BioTalent Canada Welcomes the Federal Government’s Three-year Funding Commitment for the Student Work Placement Program

BioTalent Canada Welcomes the Federal Government’s Three-year Funding Commitment for the Student Work Placement Program




BioTalent Canada Welcomes the Federal Government’s Three-year Funding Commitment for the Student Work Placement Program

OTTAWA, Ontario–(BUSINESS WIRE)–#ait–BioTalent Canada applauds the Government of Canada’s decision in Budget 2025 to grant a further 3-year extension to the Student Work Placement Program (SWPP). This important step signals that Canada is treating youth employment and skills development as a strategic, long-term investment in our workforce development and economic sovereignty.


“Today’s announcement is a very positive one for young Canadians, for employers, and for Canada’s competitiveness,” said Rob Henderson, President & CEO of BioTalent Canada. “By making SWPP a fixture on the talent landscape for the foreseeable future, the government is unlocking stable pathways into meaningful work for young talent and helping employers build the future-ready workforce we so urgently need.”

The Student Work Placement Program over its 8-year lifetime, has delivered strong outcomes: by linking post-secondary students with meaningful, paid work opportunities, the program helps translate classroom learning into on-the-job experience, gives employers access to emerging talent, and strengthens Canada’s labour market resilience. The extension is reflective of the current program’s high rate of satisfaction among employers and students, the partnerships forged, and its efficiency in delivery.

Mr. Henderson added: “This isn’t simply good news, it’s a signal that Canada values its young people, invests in their potential, and expects them to be part of the solution to our national productivity and innovation challenges. Our job now is to make this commitment count.”

About BioTalent Canada

BioTalent Canada supports the people behind life-changing science. Trusted as the go-to source for labour market intelligence, BioTalent Canada guides bio-economy contributors with evidence-based data and industry-driven standards. BioTalent Canada, as a workforce development council, is focused on igniting the industry’s brainpower, bridging the gap between job-ready talent and employers, and ensuring the long-term agility, resiliency, and sustainability of one of Canada’s most vital sectors.

BioTalent Canada has received varied distinctions following a thorough and independent analysis of the organization. By practicing the same industry standards it recommends to partners, the organization has been honored with the following titles:

  • Great Place to Work® since 2019 and one of the Best Workplaces in Healthcare for 2023 by Great Place to Work Canada®
  • The Best Leader in Diversity, Equity, and Inclusion at the 2024 Best Ottawa Business Awards
  • 2024 Collaboration Catalyst by Magnet Network
  • One of Canada’s Best Places to Work by HRD Canada for 2024
  • 5-Star Diversity, Equity and Inclusion Employer by Canadian HR Reporter since 2023
  • Employer of Choice by Canadian HR Reporter for 2025

For more information, visit biotalent.ca.

Contacts

Media Contact:

Eli Duern

Marketing and Communications Project Manager

BioTalent Canada

eduern@biotalent.ca
613-235-1402 ext. 225

Bristol Myers Squibb Announces Cash Tender Offers to Purchase Certain Notes

Bristol Myers Squibb Announces Cash Tender Offers to Purchase Certain Notes




Bristol Myers Squibb Announces Cash Tender Offers to Purchase Certain Notes

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) (“Bristol Myers Squibb” or the “Offeror”), announced the commencement of tender offers (“Offers”) to purchase for cash certain of its outstanding notes (collectively, the “Notes”) as described in the tables below.


Pool 1

Offers to purchase for cash up to $4,000,000,000 aggregate purchase price for the securities listed in the priority order below.

Title of

Security

CUSIP/ ISIN
Number(s)

Principal Amount

Outstanding

Acceptance

Priority Level

Reference

U.S. Treasury

Security(1)

Bloomberg

Reference

Page

Fixed

Spread

(basis

points)(1)

Early Tender

Premium(2)

4.950% Notes due 2026

110122ED6/ US110122ED68

$1,000,000,000

1

4.000% UST due February 15, 2026

FIT3

10

$50

3.200% Notes due 2026

110122CN6/ US110122CN68/ 110122CA4/ US110122CA48/ U11009BA1/ USU11009BA16

$1,749,998,000

2

4.125% UST due June 15, 2026

FIT3

10

$50

4.900% Notes due 2027

110122EE4/ US110122EE42

$1,000,000,000

3

4.000% UST due January 15, 2027

FIT4

10

$50

3.900% Notes due 2028

110122DE5/ US110122DE50/ 110122BQ0/ US110122BQ09/ U11009AQ7/ USU11009AQ76

$1,456,162,000

4

4.125% UST due November 15, 2027

FIT5

20

$50

4.900% Notes due 2029

110122EF1/ US110122EF17

$1,750,000,000

5

3.625% UST due October 31, 2030

FIT1

10

$50

3.400% Notes due 2029

110122CP1/ US110122CP17/ 110122CB2/ US110122CB21/ U11009BB9/ USU11009BB98

$2,399,977,000

6

3.625% UST due October 31, 2030

FIT1

15

$50

Pool 2

Offers to Purchase for cash up to $3,000,000,000 aggregate purchase price for the securities listed below in the priority listed below.

Title of

Security

CUSIP/ ISIN
Number(s)

Principal Amount

Outstanding

Acceptance

Priority Level

Reference

U.S. Treasury

Security(1)

Bloomberg

Reference

Page

Fixed

Spread

(basis

points)

Early Tender

Premium(2)

6.875% Debenture due 2097

110122AC2/ US110122AC22

$62,417,000

1

4.750% UST due August 15, 2055

FIT1

140

$50

6.400% Notes due 2063

110122EC8/ US110122EC85

$1,250,000,000

2

4.750% UST due August 15, 2055

FIT1

85

$50

6.250% Notes due 2053

110122EB0/ US110122EB03

$1,250,000,000

3

4.750% UST due August 15, 2055

FIT1

70

$50

5.650% Notes due 2064

110122EL8/ US110122EL84

$1,750,000,000

4

4.750% UST due August 15, 2055

FIT1

85

$50

5.900% Notes due 2033

110122DZ8/ US110122DZ89

$1,000,000,000

 

5

4.250% UST due August 15, 2035

FIT1

25

$50

5.750% Notes due 2031

110122DY1/ US110122DY15

$1,000,000,000

6

3.625% UST due October 31, 2030

FIT1

30

$50

5.550% Notes due 2054

110122EK0/ US110122EK02

$2,750,000,000

7

4.750% UST due August 15, 2055

FIT1

70

$50

5.200% Notes due 2034

110122EH7/ US110122EH72

$2,500,000,000

8

4.250% UST due August 15, 2035

FIT1

35

$50

5.100% Notes due 2031

110122EG9/ US110122EG99

$1,250,000,000

9

3.625% UST due October 31, 2030

FIT1

30

$50

(1)

The Total Consideration (as defined below) for each series of Notes will be based on the fixed spread for the applicable series of Notes plus the yield of the specified Reference U.S. Treasury Security for that series as of 10:00 a.m. (New York City time) on November 18, 2025 unless extended with respect to any Offer (as defined below) (such date and time with respect to an Offer, as the same may be extended with respect to such Offer, the “Price Determination Date”). The Total Consideration does not include the applicable Accrued Coupon Payment (as defined below), which will be payable in cash in addition to the applicable Total Consideration. For the avoidance of doubt, the Early Tender Premium is included in the Total Consideration calculated based on the fixed spread for the applicable series of Notes and is not in addition to the Total Consideration.

 

(2)

Payable, as part of the applicable Total Consideration, per each $1,000 principal amount of the specified series of Notes validly tendered at or prior to the applicable Early Tender Deadline (as defined below) and accepted for purchase (the “Early Tender Premium”). The total consideration for each $1,000 principal amount of each series of Notes validly tendered at or prior to the applicable Early Tender Deadline (including the Early Tender Premium) is referred to as the “Total Consideration” for such series. Holders of Notes (each, a “Holder” and collectively, “Holders”) who validly tender Notes of a series after the applicable Early Tender Deadline, but at or prior to the applicable Expiration Date (as defined below), will receive the tender consideration for any such series accepted for purchase by the Offeror, which is equal to the Total Consideration minus the Early Tender Premium (with respect to such series, the “Tender Consideration”).

The outstanding debt securities listed in (i) the first table above labeled “Pool 1” are referred to collectively as the “Pool 1 Notes,” and (ii) the second table above labeled “Pool 2” are referred to as the “Pool 2 Notes.” The Pool 1 Notes and the Pool 2 Notes are referred to collectively as the “Notes,” and each series of Notes is referred to as a “series.” The offers to purchase the Pool 1 Notes are referred to collectively as the “Pool 1 Offers,” the offers to purchase the Pool 2 Notes are referred to as the “Pool 2 Offers,” and each offers to purchase a series of Notes is referred to as an “Offer.”

The Offers are subject to the terms and conditions described in the Offer to Purchase dated November 3, 2025 (as it may be amended or supplemented from time to time, the “Offer to Purchase”) which sets forth a detailed description of the Offers, including (i) the Acceptance Priority Procedures (as described below), (ii) a $4,000,000,000 maximum aggregate purchase price of the Pool 1 Notes validly tendered in the Pool 1 Offers, excluding the applicable Accrued Coupon Payments (the “Pool 1 Maximum”), and (iii) a $3,000,000,000 maximum aggregate purchase price of the Pool 2 Notes validly tendered in the Pool 2 Offers, excluding the applicable Accrued Coupon Payments (the “Pool 2 Maximum”).

The primary purpose of the Offers is to acquire the maximum principal amount of Pool 1 Notes and Pool 2 Notes in the designated priority order for which the aggregate purchase price (excluding the applicable Accrued Coupon Payments) does not exceed the Pool 1 Maximum and the Pool 2 Maximum, respectively. Notes that are accepted and purchased in the Offers will be canceled and will no longer remain outstanding obligations of the Offeror. The Offers are subject to certain other general conditions as described in the Offer to Purchase, as well as the condition that BMS Ireland Capital Funding Designated Activity Company, a wholly-owned subsidiary of Bristol Myers Squibb (“Finance Sub”), shall have completed an offering of debt securities (the “New Notes Offering”) on terms and conditions satisfactory to Bristol Myers Squibb that results in the receipt of net proceeds that, when taken together with approximately $3.0 billion of Bristol Myers Squibb’s cash on hand, is sufficient to pay the consideration for all Notes validly tendered (and not validly withdrawn) and accepted for purchase by Bristol Myers Squibb, plus accrued and unpaid interest and related fees and expenses (the “Financing Condition”). The Offers are not conditioned on any minimum amount of Notes being tendered, and none of the Offers are conditioned on the consummation of the other Offers. Each Offer may be amended, extended or, upon failure of a condition to be satisfied or waived prior to the applicable Early Tender Deadline (for any Offers for which the Offeror elects to exercise its Early Settlement Right (as defined below)) or the applicable Expiration Date (for any Notes not settled on the Early Settlement Date), terminated individually.

The Offers will each expire at 5:00 p.m. (New York City time) on December 3, 2025, unless extended or earlier terminated by the Offeror (such date and time with respect to an Offer, as the same may be extended with respect to such Offer, the “Expiration Date”). To be eligible to receive the Total Consideration, which includes the Early Tender Premium, Holders must validly tender their Notes at or prior to 5:00 p.m. (New York City time) on November 17, 2025, unless extended (such date and time with respect to an Offer, as the same may be extended with respect to such Offer, the “Early Tender Deadline”). Holders who validly tender their Notes after the applicable Early Tender Deadline, but at or prior to the applicable Expiration Date, will be eligible to receive the Tender Consideration for any such series accepted for purchase. Bristol Myers Squibb expects to use the net proceeds from the New Notes Offering by the Finance Sub announced today, together with approximately $3.0 billion of Bristol Myers Squibb’s cash on hand, to pay to Holders whose Notes are accepted in an Offer the Total Consideration or the Tender Consideration, as applicable, and any Accrued Coupon Payments.

All Holders whose Notes are accepted in an Offer will receive a cash payment equal to accrued and unpaid interest on such Notes to, but not including, the relevant Settlement Date (as defined below) (the “Accrued Coupon Payment”) in addition to their Total Consideration or Tender Consideration, as applicable.

  • Notes may be validly withdrawn at any time at or prior to 5:00 p.m. (New York City time) on November 17, (such date and time with respect to an Offer, as the same may be extended with respect to such Offer), but not thereafter, unless extended with respect to any Offer. Holders should not tender any Notes that they do not wish to be accepted for purchase.

Subject to the satisfaction or waiver of the Financing Condition and the other conditions of the Offers, the “Acceptance Priority Procedures” will operate concurrently, but separately, for the Pool 1 offers and the Pool 2 offers, in each case, as follows:

  • first, if the aggregate cash purchase price (excluding the applicable Accrued Coupon Payments) of all Pool 1 Notes or Pool 2 Notes, as applicable, validly tendered at or prior to the applicable Early Tender Deadline by Holders does not exceed the applicable maximum limit, then the Offeror will accept all such Notes. However, if the aggregate cash purchase price (excluding the applicable Accrued Coupon Payments) of all Pool 1 Notes or Pool 2 Notes, as applicable, validly tendered at or prior to the applicable Early Tender Deadline by Holders exceeds the applicable maximum limit, then the Offeror will (i) accept such Notes for purchase for cash, starting at the highest acceptance priority level (level 1) and, if there is more than one priority level, moving sequentially to each lower acceptance priority level (the lowest of which is level 6 in the case of the Pool 1 Offers and 9 in the case of the Pool 2 Offers), until the aggregate cash purchase price (excluding the applicable Accrued Coupon Payments) of such Notes equals the applicable maximum limit, (ii) prorate the series of such Notes with the lowest acceptance priority level accepted for purchase for cash and (iii) not accept for purchase for cash (x) any such Notes of a series with an acceptance priority level below the prorated series or (y) any Pool 1 Notes or Pool 2 Notes, as applicable, validly tendered after the applicable Early Tender Deadline; and
  • second, if the applicable maximum limit is not exceeded at the applicable Early Tender Deadline, the Offeror will repeat the steps described in the prior bullet with respect to all Pool 1 Notes or Pool 2 Notes, as applicable, validly tendered after the applicable Early Tender Deadline, but at or prior to the applicable Expiration Date, in order to determine the aggregate principal amount of such Notes that the Offeror will accept for purchase in the Pool 1 Offers and/or the Pool 2 Offers, as applicable.
  • All Pool 1 Notes, regardless of acceptance priority level, that are validly tendered at or prior to the applicable Early Tender Deadline will have priority over Pool 1 Notes validly tendered after the applicable Early Tender Deadline and at or prior to the applicable Expiration Date.
  • All Pool 2 Notes, regardless of acceptance priority level, that are validly tendered at or prior to the applicable Early Tender Deadline will have priority over Pool 2 Notes validly tendered after the applicable Early Tender Deadline and at or prior to the applicable Expiration Date.

Provided that the Financing Condition and the other conditions to the applicable Offer have been satisfied or waived by the Offeror by the applicable Early Tender Deadline, the Offeror may, but is not obligated to, elect to exercise its right (the “Early Settlement Right”), with respect to any Offer for which the conditions have been satisfied or waived, to settle all Notes validly tendered at or prior to the applicable Early Tender Deadline and accepted for purchase in such Offer (the “Early Settlement Date”). The Early Settlement Date will be determined at the Offeror’s option and is currently expected to occur on the third business day immediately following the Early Tender Deadline. If the Offeror elects to exercise its Early Settlement Right with respect to any Offer, the Offeror will settle all Notes validly tendered at or prior to the applicable Early Tender Deadline and accepted for purchase in such Offer on the Early Settlement Date. If the Offeror elects to exercise its Early Settlement Right with respect to any Offer, the Offeror will announce in a press release promptly after the applicable Early Tender Deadline that it is exercising its Early Settlement Right with respect to such Offer. On the Early Settlement Date, all Notes validly tendered at or prior to the applicable Early Tender Deadline and accepted for purchase in the Offer for which the Offeror has elected to exercise its Early Settlement Right will receive the applicable Total Consideration and Accrued Coupon Payment. The “Final Settlement Date,” if any, is the date on which the Offeror will settle all Notes validly tendered and accepted for purchase and not previously settled on the Early Settlement Date. The Final Settlement Date is expected to be the second business day following the applicable Expiration Date, unless extended with respect to any Offer. Each of the Early Settlement Date and the Final Settlement Date is referred to as a “Settlement Date.”

Promptly after the Price Determination Date, the Offeror intends to issue a press release specifying, among other things, the Offer Yield and Total Consideration for each series of Notes, the aggregate principal amount of Notes validly tendered at or prior to the applicable Early Tender Deadline and, if applicable, accepted in each Offer and the proration factor (if any) applied to such validly tendered Notes with respect to each Offer.

The Offeror expressly reserves the right, in its sole discretion, subject to compliance with applicable law and regulations, not to purchase any Notes or to extend, amend and/or terminate its Offers and to amend or waive the Financing Condition and any of the other terms and conditions of any Offer. Holders are advised to read carefully the Offer to Purchase for full details of and information on the procedures for participating in the Offer, as applicable. If the Offeror terminates any Offer with respect to one or more series of Notes, it will give written notice thereof to the Tender and Information Agent (as defined below) and will make a public announcement thereof as promptly as practicable, and all Notes tendered pursuant to such terminated Offer will be returned promptly to the tendering Holders thereof. With effect from such termination, any Notes blocked in The Depository Trust Company (“DTC”) will be released. Holders are advised to check with any bank, securities broker or other intermediary through which they hold Notes as to when such intermediary would need to receive instructions from a beneficial owner in order for that holder to be able to participate, or withdraw their instruction to participate, in the Offers before the deadlines specified herein and in the Offer to Purchase. The deadlines set by any such intermediary and DTC for the submission and withdrawal of tender instructions will also be earlier than the relevant deadlines specified herein and in the Offer to Purchase.

The Offeror has retained Citigroup Global Markets Inc., Deutsche Bank Securities Inc., Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC as dealer managers for the Offers. Questions regarding terms and conditions of the Offers should be directed to Citigroup Global Markets Inc. at (800) 558-3745 (toll-free) or (212) 723-6106 (collect) or Deutsche Bank Securities Inc. at (866) 627-0391 (toll-free) or (212) 250-2955 (collect) or Goldman Sachs & Co. LLC at (800) 828-3182 (toll-free) or (212) 357-1452 (collect) or Morgan Stanley & Co. LLC at (800) 624-1808 (toll-free) or (212) 357-1452 (collect). Global Bondholder Services Corporation will act as the tender agent and the information agent for the Offers (the “Tender and Information Agent”).

The full details of the Offers, including instructions on how to tender Notes, are included in the Offer to Purchase. Holders are strongly encouraged to read carefully the Offer to Purchase, including documents incorporated by reference therein, because they will contain important information. The Offer to Purchase is available on Global Bondholder Services Corporation’s website at https://www.gbsc-usa.com/bristol-myers/ or obtained from Global Bondholder Services Corporation at (855) 654-2014 (toll-free) or (212) 430-3774 (collect). You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Offers.

None of the Offeror or its affiliates, its board of directors, the dealer managers, the Tender and Information Agent or the trustee with respect to the Notes is making any recommendation as to whether Holders should tender any Notes in response to the Offers, and neither the Offeror nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

After the applicable Expiration Date, Bristol Myers Squibb or its affiliates may from time to time purchase additional Notes in the open market, in privately negotiated transactions, through tender offers, exchange offers or otherwise, or Bristol Myers Squibb may redeem any series of Notes pursuant to the terms of the indenture governing the Notes. Any future purchases may be on the same terms or on terms that are more or less favorable to Holders of Notes than the terms of the Offers and, in either case, could be for cash or other consideration. In particular, to the extent that less than all of the outstanding 4.950% Notes due 2026, 4.900% Notes due 2027 or 3.900% Notes due 2028 are tendered and accepted for purchase pursuant to the Offers, the Offeror may, at its sole discretion (but is under no obligation to do so), give a notice of optional redemption with respect to such series of Notes to redeem all or a portion of such series of Notes that remain outstanding after completion of the Offers in accordance with their terms. The price paid in any such redemption will be determined in accordance with the terms of the applicable series of Notes, and such price may differ significantly from the Total Consideration or the Tender Offer Consideration for such series of Notes pursuant to the Offers. Depending on the results of the Offers, such redemption notice, if any, may be given by the Offeror on or after the Early Tender Deadline. The Offer to Purchase does not constitute a notice of redemption and does not create an obligation to issue any notice of redemption, redeem any series of Notes or satisfy or discharge the indenture governing the Notes.

Offer and Distribution Restrictions

This announcement is for informational purposes only. This announcement is not an offer to sell or purchase, a solicitation of an offer to sell or purchase, or the solicitation of tenders with respect to any of Notes described herein. The Offers are being made solely pursuant to the Offer to Purchase. The Offers are not being made to Holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Offers to be made by a licensed broker or dealer, the Offers will be deemed to be made on behalf of the Offeror by the dealer managers or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction. Neither this announcement nor the Offer to Purchase is an offer to sell, or the solicitation of an offer to purchase, any securities in the New Notes Offering.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements regarding, among other things, the timing, terms, conditions and other aspects of the Tender Offer and the New Notes Offering. You can identify these forward-looking statements by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of, among other things, the Offers and the New Notes Offering and the use of proceeds therefrom, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed.

Forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond its control and could cause its future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: general market conditions which might affect the Tender Offer and the New Notes Offering; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; and access to capital markets.

Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in its Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this press release are made only as of the date of this press release and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve.

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Contacts

For more information:
Media Relations:
media@bms.com

Investor Relations:
investor.relations@bms.com

KCAS Bio Strengthens Board of Directors with Appointment of Paul Kirchgraber and Kurt Doyle

KCAS Bio Strengthens Board of Directors with Appointment of Paul Kirchgraber and Kurt Doyle




KCAS Bio Strengthens Board of Directors with Appointment of Paul Kirchgraber and Kurt Doyle

OLATHE, Kan.–(BUSINESS WIRE)–KCAS Bio, a leading contract research organization (CRO) specializing in comprehensive bioanalytical and biomarker services, is delighted to announce the appointment of Dr. Paul Kirchgraber and Mr. Kurt Doyle to its Board of Directors. Their addition marks a significant milestone in KCAS Bio’s continued growth and strategic evolution in the global life sciences industry. KCAS Bio is headquartered in the Kansas City, Kansas metropolitan area with operating sites in the greater Philadelphia area; Lyon, France; and a partnership in Melbourne, Australia. The Company is backed by Vitruvian Partners, one of the world’s leading growth-focused investment firms.


Dr. Paul Kirchgraber brings decades of leadership experience in clinical research and laboratory operations. He served as Executive Vice President and CEO of Covance, Labcorp’s Drug Development Division, where he led global teams in drug and medical device development in over 60 countries. Dr. Kirchgraber has experience running global pre-clinical, central and bioanalytical labs as well as phase one through four clinical services. He also served as Chairman of the Association of Clinical Research Organizations. His expertise in laboratory medicine and strategic operations will be instrumental in guiding KCAS Bio’s scientific and business initiatives.

Mr. Kurt Doyle is a seasoned executive with deep experience in commercial strategy and business development within the pharmaceutical and biotech sectors. He has spent 26 years at IQVIA, most recently as Senior Vice President – Large Pharma and Specialty Services, where he drove growth through client engagement, operational excellence, and strategic partnerships. Mr. Doyle’s insights into market dynamics and customer needs will support KCAS Bio’s mission to deliver high-quality, client-focused solutions across the drug development continuum.

“We are thrilled to welcome Paul and Kurt to our Board,” said John Bucksath, CEO of KCAS Bio. “Their combined experience and leadership will be invaluable as we continue to expand our capabilities and deliver innovative solutions to our clients. Their strategic vision aligns perfectly with our commitment to scientific excellence and operational excellence.”

Sophie Bower-Straziota, Partner at Vitruvian Partners, commented, “KCAS Bio has grown tremendously since we backed John and his team. We are delighted to welcome Paul and Kurt to the Board to support KCAS Bio’s continued expansion in its ability to serve the world’s largest pharma companies and biotechs in accelerating time to market for their most valuable therapeutics.”

The appointments of Dr. Kirchgraber and Mr. Doyle reflect KCAS Bio’s dedication to building a world-class leadership team to support its mission of accelerating life-changing therapies to market.

Further information:

About KCAS Bio – KCAS Bio is a leading global Contract Research Organization providing comprehensive GLP-compliant bioanalytical and biomarker development testing services for the biopharma industry. The company offers a complete range of bioanalytical services from early discovery support through new product registration, providing market leading expertise in biological (large molecule) and synthetic (small molecule) drug candidates. Vitruvian’s investments have positioned KCAS Bio to continue growing operations across all its sites globally; continue the rapid hiring of top scientific talent and focus on outstanding customer service; and accelerate internationalization including through acquisitions. KCAS Bio is headquartered in Olathe, Kansas and has c. 380 employees. Further information regarding KCAS Bio can be found at www.kcasbio.com.

About Vitruvian – Vitruvian Partners is a global growth-focused investor with offices across London, Miami, San Francisco, Stockholm, Munich, Madrid, Luxembourg, Mumbai, Singapore, and Shanghai. Vitruvian focuses on dynamic situations characterized by rapid growth and change across asset-light industries. Vitruvian has over $20 billion of active funds which have backed many leaders in their sectors, including Just Eat, Arrive, Skyscanner, Medison, CRF Health, DeepIntent, Global-e, and Darktrace. Further information can be found at www.vitruvianpartners.com.

Contacts

For media inquiries, please contact:

Media Relations
KCAS Bio

Phone: (913) 248-3000

Email: pressrelease@kcasbio.com
Website: https://www.kcasbio.com

Kyowa Kirin International Announces Appointment of Julie Dehaene-Puype as President for the Region

Kyowa Kirin International Announces Appointment of Julie Dehaene-Puype as President for the Region




Kyowa Kirin International Announces Appointment of Julie Dehaene-Puype as President for the Region

  • Julie Dehaene-Puype joins Kyowa Kirin as new President of the International Region
  • Jeremy Morgan will retire at the end of December 2025 after a two-month leadership transition period

GALASHIELS, Scotland & MARLOW, England–(BUSINESS WIRE)–Kyowa Kirin International (“KKI”), a group company of Kyowa Kirin Co., Ltd. (TSE:4151, “Kyowa Kirin”), a Japan-based Global Specialty Pharmaceutical Company, today announced the appointment of Julie Dehaene-Puype as President for the Region, effective 1 November 2025. Julie follows the tenure of Jeremy Morgan, who has served as President for the International Region since 2023. Morgan will serve in an advisor role to the business through to the end of 2025, working in partnership with Dehaene-Puype to ensure a successful and smooth change for the company.


“We are very pleased to welcome Julie to the company in the role as President of KKI,” said Tomohiro Sudo, Chief International Business Officer of Kyowa Kirin. “Julie joins us with extensive experience in global biotech and pharma spanning a 25-year career. I am confident that her expertise and her strong passion and care for people and patients will significantly contribute to KKI’s future growth for patients’ smiles, and we are looking forward to working in partnership with her toward our Vision for 2030.”

“I want to thank Jeremy Morgan on behalf of Kyowa Kirin,” said Abdul Mullick, Ph.D., President and COO of Kyowa Kirin. “For his unwavering leadership and care for KKI employees, and for putting patients first. From the moment Jeremy joined KKI, he brought a purpose and an energy for the needs of the communities we serve. We thank Jeremy for the lasting impact he has made whilst at the helm of Kyowa Kirin, and for carrying the business through transformation into a stable, growing organization that is truly living our purpose to make people smile.”

Julie Dehaene-Puype joins Kyowa Kirin with more than 25 years of experience in the global pharmaceutical industry spanning general management, commercial operations, new product development and regulatory affairs. Julie’s background encompasses roles across a number of global pharmaceutical organisations including Mundipharma, Takeda, Merck/MSD, and Schering-Plough. Julie also sits on the board of Lytix Biopharma as a Non-Executive Director.

“I am thrilled to be joining Kyowa Kirin – a company with a 76-year legacy of science, innovation and partnership, and a deep commitment to advancing care in rare diseases and oncology,” stated Dehaene-Puype. “From my first days, I can already feel the passion and drive of the people at KKI, united by a shared purpose: To make more people smile. I look forward to working with my new colleagues to deliver even more for the patients who place their trust in us.”

Julie has a PharmD, a Masters in Pharmaceutical Regulatory Affairs and a Masters in Biological and Medical Sciences from the University of Lille, France. She has lived and worked in France, Belgium, Switzerland and the US. Currently, she resides in Switzerland, and she will be regularly present in the Marlow, UK headquarters as well as in the country offices throughout the region.

The leadership change announced today echoes role changes across the wider company. Earlier in the year, the global entity announced a new dual CEO-COO leadership structure to help support the business’ continued growth, with Abdul Mullick appointed President and COO, to oversee the execution of all business operations at the global level.

About Kyowa Kirin

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International.

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

Contacts

For more information, please contact:
Stacey Minton

Senior Vice President, Corporate Affairs, Kyowa Kirin International

stacey.minton@kyowakirin.com

Sarah McDonald-Barker

Director, Corporate Affairs, Kyowa Kirin International

sarah.mcdonald@kyowakirin.com

Merz Aesthetics® Introduces New BELOTERO® Syringe Offering Greater Precision, Comfort and Ease of Use

Merz Aesthetics® Introduces New BELOTERO® Syringe Offering Greater Precision, Comfort and Ease of Use




Merz Aesthetics® Introduces New BELOTERO® Syringe Offering Greater Precision, Comfort and Ease of Use

Redesigned syringe seamlessly blends innovation and functionality, setting a new standard for precision and ease in the injection experience.

RALEIGH, N.C.–(BUSINESS WIRE)–Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the launch of a new syringe for its category-leading hyaluronic acid (HA) brand BELOTERO®. The new syringe is ergonomically engineered to elevate the treatment experience, offering greater precision, comfort, and ease of use. The new syringe will launch first in Europe and then will expand to markets worldwide.




“As the first region to introduce this innovation ahead of our global expansion, I’m proud to share this exciting milestone in BELOTERO®’s history as a trusted leader in hyaluronic acid treatments,” said Gonzalo Mibelli, President EMEA region.

What is BELOTERO®?

BELOTERO® is the first and only biomimetic hyaluronic acid (HA) treatment with a Cohesive Polydensified Matrix (CPM)® gel, designed to mimic characteristics and behavior of the skin and deep layers. The brand features a full portfolio with tailored solutions to enhance facial features, improve skin quality, and reduce signs of aging, with natural-looking, long-lasting results. BELOTERO® recently marked 20 successful years in the aesthetics market, with over 18 million syringes sold worldwide, a true testament to its legacy.3

Smart Design. Precise Control.

“From a design perspective, the new BELOTERO® syringe delivers both aesthetics and functionality, particularly with its excellent haptics and ergonomic finger-grip,” said Dr. Tatjana Pavicic, a board-certified dermatologist in Munich, Germany. “The anti-slip, signature color-coded silicone surfaces enhance user experience, providing easy identification, practitioner comfort, and stability during procedures.”

With a patent-protected design developed exclusively for BELOTERO®, the new premium syringe, with the same trusted formula, stands out in the global marketplace with several key improvements, such as:

  • Ergonomic Design: The redesigned syringe offers a more comfortable grip, making handling easier during procedures.4
  • Precision at Every Angle: Engineered for consistent syringe performance, the syringe adapts to various angles, providing greater control and stability.
  • Improved Safety Design: An integrated Luer Lock system keeps the needle securely attached, supporting safer administration.

Clinically Validated and Recognized by Experts.

“We are thrilled that our new BELOTERO® syringe has already been recognized by a panel of expert users for providing the volume control, adaptability and consistent handling we know our customers and patients are looking for,” said Alexis Stern, Global Chief Marketing Officer at Merz Aesthetics. “In fact, 93% of users rated the new BELOTERO® syringe as easy and intuitive.”4

The new BELOTERO® syringe will launch starting with BELOTERO® Balance Lidocaine, BELOTERO® Soft Lidocaine, and BELOTERO® Intense Lidocaine in Austria, Belgium, Netherlands, Luxembourg, Germany, Italy, Switzerland, Spain, Portugal, the United Kingdom, Ireland, and Malta, followed by a phased global rollout. All BELOTERO® products with the current syringe remain safe and effective to use as indicated.

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients, and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

Important BELOTERO® Soft Lidocaine, BELOTERO® Balance Lidocaine, and BELOTERO® Intense Lidocaine Hyaluronic Acid Treatment Considerations (Regions to update based on local safety language)

BELOTERO® Soft Lidocaine is an injectable biodegradable implant intended for filling of perioral fine lines. BELOTERO® Soft Lidocaine is a device without an intended medical purpose. BELOTERO® Soft Lidocaine is indicated for injection into the superficial to mid-dermis for treatment of perioral fine lines.

BELOTERO® Balance Lidocaine is an injectable biodegradable implant intended for filling of facial wrinkles and folds as well as for lip enhancement. BELOTERO® Balance Lidocaine is a device without an intended medical purpose. BELOTERO® Balance Lidocaine is indicated for injection into the superficial to mid-dermis for treatment of naso-labial folds, marionette lines, perioral lines and oral commissures. BELOTERO® Balance Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.

BELOTERO® Intense Lidocaine is an injectable biodegradable implant intended for filling of deep facial wrinkles and folds as well as to restore and enhance soft tissue volume. BELOTERO® Intense Lidocaine is a device without an intended medical purpose. BELOTERO® Intense Lidocaine is indicated for injection into the deep dermis for treatment of nasolabial folds and marionette lines. BELOTERO® Intense Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.

References

  1. Patent Note: WO 2005/085329 “Biocompatible crosslinked gel.”
  2. Casabona G, et al. 2025, AMWC Congress, The Cohesive Polydensified Matrix Hyaluronic Acid (CPM-HA) Gels Demonstrate Biomimetic Tissue Plane Adaptation: An Integrative Analysis of Physiochemical Properties.
  3. Data on File. (CE approval).
  4. Data on file. 2021 Emergo Design Change Validation Report.

 

Contacts

Media Contact
Merz Aesthetics

Global Corporate Communications

6501 Six Forks Road, Raleigh NC 27615

919-302-3296

media@merz.com

Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus

Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus




Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus

– Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion –

– Gazyva has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide –

– If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity –

– These positive results follow the recent U.S. FDA approval and positive EU CHMP opinion for Gazyva in lupus nephritis, alongside positive Phase III data from the INShore study in idiopathic nephrotic syndrome –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from the Phase III ALLEGORY study of Gazyva® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva versus standard therapy. SRI is a tool that assesses changes in disease severity, symptoms and physical condition to indicate whether treatment is effective at controlling disease activity. All key secondary endpoints were also met. No new safety signals were identified, and safety was in line with the well-characterized profile of Gazyva.


“Systemic lupus erythematosus is a lifelong condition that can cause irreversible damage to the major organs in the body, leading to life-threatening complications. These pivotal results are unprecedented in demonstrating that by effectively controlling disease activity, Gazyva may delay or prevent further organ damage in people with SLE,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to sharing the data with global health authorities, with the goal of making this potentially transformative new standard of care available as quickly as possible.”

All key secondary endpoints were met, with results showing statistically significant and clinically meaningful benefits with Gazyva versus standard therapy including British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response at week 52, sustained corticosteroid control from week 40 to 52, sustained SRI-4 from week 40 to 52, a six-point improvement in SLE disease activity score (SRI-6) at 52 weeks, and time to first flare over 52 weeks as defined by the British Isles Lupus Assessment Group (BILAG) index.

SLE affects over three million people worldwide, mostly women diagnosed between the ages of 15 and 45, with women of color disproportionately impacted. Frequent flares of disease activity inflame and damage multiple organs. Around half of the patients will progress to lupus nephritis, a potentially life-threatening kidney complication, within five years of diagnosis. Achieving better disease control can reduce flares, limit further damage to the organs and lower the risk of developing lupus nephritis.

Data will be presented at an upcoming medical meeting and shared with health authorities as soon as possible, including the U.S. Food and Drug Administration and the European Medicines Agency. If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, an underlying cause of disease.

ALLEGORY is the third positive Phase III study for Gazyva in immune-mediated diseases, in addition to REGENCY in lupus nephritis and INShore in idiopathic nephrotic syndrome. This growing evidence suggests that Gazyva, designed to attack and destroy targeted B cells, both directly and together with the body’s immune system, may help address disease activity across a spectrum of autoimmune or immune-related diseases.

In addition to SLE, Gazyva is being investigated in children and adolescents with lupus nephritis, as well as adults with membranous nephropathy, as part of our ambition to be leaders in immune-mediated rheumatology and nephrology diseases.

About Gazyva

Gazyva® (obinutuzumab) is a humanized monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva is approved for adults with lupus nephritis in the U.S. who are receiving standard therapy. In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in the European Union, with a final decision expected from the European Commission in the near future. Gazyva is also approved in 100 countries for various types of hematological cancers.

About the ALLEGORY Study

ALLEGORY [NCT04963296] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study, investigating the efficacy and safety of Gazyva® (obinutuzumab) compared with standard therapy in adults with systemic lupus erythematosus (SLE) on standard therapy. The study enrolled approximately 300 people, who were randomized 1:1 to receive Gazyva or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva for up to 104 weeks. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and rising. Due to the non-specific symptoms, it can take two to six years for an accurate diagnosis. During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.

Around half of people with SLE will develop lupus nephritis within five years of a lupus diagnosis. In lupus nephritis, the disease activity primarily affects the kidneys and there is a risk of end-stage kidney disease, where dialysis and transplant are the only treatment options.

There is a need for additional targeted therapies that can effectively control disease activity and potentially delay or prevent the onset of lupus nephritis.

GAZYVA Indications

GAZYVA® (obinutuzumab) is a prescription medicine used:

  • With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment
  • With the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment
  • With chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment
  • for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy

Important Safety Information

The most important safety information patients should know about GAZYVA

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA:

Patients should NOT receive GAZYVA if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past.

Additional possible serious side effects of GAZYVA:

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion-related reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion-related reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Symptoms of infusion-related reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
  • Hypersensitivity Reactions Including Serum Sickness: Some patients receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue GAZYVA
  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN
  • Serious, Including Fatal, Infections: While the patient is taking GAZYVA, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If the patient develops a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection.
  • Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections
  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking GAZYVA, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If the patient’s platelet count gets too low, their treatment may be delayed or reduced
  • Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by the patient’s doctor as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.

The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.

The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion infusion-related reactions, and neutropenia.

Before receiving GAZYVA, patients should talk to their doctor about:

  • Immunizations: Before receiving GAZYVA therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines
  • Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may harm their unborn baby. The patient should speak to their doctor about using GAZYVA while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment
  • Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patients should not breastfeed while taking GAZYVA and for 6 months after your last dose

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.

GAZYVA is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech in Immunology

Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated inflammatory diseases. Our pipeline includes over a dozen clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery and R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Kendall Tich, (650) 467-6800

Advocacy Contact:

Meg Harrison, (617) 694-7060

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary




Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

  • Samsung Epis Holdings to be listed on Korea Exchange (KRX) on November 24, 2025
  • Samsung Epis Holdings to focus on exploring next-generation growth drivers and optimizing business strategies for its subsidiaries ‒Samsung Bioepis and a new company under Samsung Epis Holdings
  • Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings while the new subsidiary company under Samsung Epis Holdings will focus on developing next-generation biotechnology platforms

INCHEON, Korea–(BUSINESS WIRE)–#SamsungBioepis–Samsung Epis Holdings Co., Ltd. today announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.




Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. “The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world,” said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. “By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers.”

Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings will optimize business strategies for its subsidiaries and maximize corporate and shareholder value through proactive R&D and investment. Samsung Epis Holdings will implement and deploy a focused growth strategy designed to ensure efficient and effective resources while reinforcing the business strategies and platforms for the two subsidiaries.

The New Subsidiary Company

The new subsidiary company under Samsung Epis Holdings will develop next-generation biotechnology platforms targeting various modalities to identify future growth engines beyond the biosimilar business and drive innovation. The new subsidiary will focus on transforming highly scalable core technologies into platforms and discovering diverse new drug candidates, including joint development with global pharmaceutical companies.

For more information about Samsung Epis Holdings and its new subsidiary, please visit: https://www.samsungepisholdings.com/en/

Samsung Bioepis Co., Ltd.

Samsung Bioepis will continue to focus on its core business, including research and development, manufacturing, supply distribution, and commercialization of biologic medicines. Since its foundation in 2012, Samsung Bioepis has developed the industry’s most rapidly advancing biosimilar medicines portfolio, with 11 biosimilars approved and available around the world. In 2024, the company achieved record-breaking sales of KRW 1.5377 trillion and operating profit of KRW 435.4 billion. Samsung Bioepis will focus on strengthening its development capabilities, with a goal of securing 20+ biosimilars in the long-term. Samsung Bioepis has already opened up access to biologic medicines across immunology, oncology, ophthalmology, hematology, and nephrology, and the company is expanding into other therapeutic areas to address unmet needs of patients. For more information about Samsung Bioepis, please visit: www.samsungbioepis.com and follow Samsung Bioepis on social media – LinkedIn, X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

Where to Get TMS Therapy in Colorado Springs Starts with Serenity Mental Health Centers

Where to Get TMS Therapy in Colorado Springs Starts with Serenity Mental Health Centers




Where to Get TMS Therapy in Colorado Springs Starts with Serenity Mental Health Centers

Serenity clinics offer accessible TMS treatment for mental health.

COLORADO SPRINGS, Colo.–(BUSINESS WIRE)–Serenity Mental Health Centers, a leader in innovative psychiatric care and one of the fastest-growing mental health providers in the nation, is setting the standard for TMS therapy in Colorado Springs.




Serenity’s board-certified psychiatrists and psychiatric mental health nurse practitioners provide full-spectrum mental health services tailored to each patient’s needs. Treatments include psychiatric evaluations, medication management, transcranial magnetic stimulation (TMS) therapy, and ketamine treatment for conditions such as depression, anxiety, PTSD, OCD, and more. These evidence-based approaches are designed for patients seeking both traditional support and non-medication treatment options.

“When people are looking for where to get TMS therapy in Colorado Springs, they need more than directions; they need hope,” said Tricia Pease, COO and co-founder. “Serenity’s call center staff is ready and available to help patients get the care they need, and fast.”

Serenity’s outpatient model includes flexible scheduling and same-day appointments, breaking down barriers that often prevent patients from receiving timely care. Serenity is committed to providing patient-first psychiatry and to becoming the go-to destination for TMS therapy in Colorado Springs.

With an 84% response rate and 78% remission rate for TMS patients, Serenity is considered one of the best TMS therapy clinics in Colorado Springs for those seeking alternatives to medication.

To book an appointment, visit https://serenitymentalhealthcenters.com/colorado-springs/ or call 719-414-2331.

About Serenity Mental Health Centers

Serenity Mental Health Centers is a leading provider of comprehensive mental health services, dedicated to transforming the lives of patients through compassionate, innovative, and evidence-based care. With 35 locations across the country, Serenity offers a wide range of treatments tailored to address various mental health conditions, including depression, anxiety, OCD and PTSD. Our highly skilled team of psychiatrists, nurse practitioners and mental health specialists combine innovative therapies like Transcranial Magnetic Stimulation (TMS) and ketamine infusion with personalized care to help patients achieve lasting wellness. Serenity is committed to expanding access to quality mental health care and fostering hope and recovery for individuals and families in the communities we serve. For more information, go to serenitymentalhealthcenters.com.

Contacts

For more information, contact:
Jillian DiMarco

jdimarco@serenityhealthcare.com

Serenity Mental Health Centers Expands Access in Colorado Springs with FDA-cleared Accelerated Deep TMS Protocol

Serenity Mental Health Centers Expands Access in Colorado Springs with FDA-cleared Accelerated Deep TMS Protocol




Serenity Mental Health Centers Expands Access in Colorado Springs with FDA-cleared Accelerated Deep TMS Protocol

Patients nationwide can access faster, convenient TMS treatment.

COLORADO SPRINGS, Colo.–(BUSINESS WIRE)–Serenity Mental Health Centers, a leader in innovative psychiatric care and one of the fastest-growing mental health providers in the nation, today announced that its patients now have immediate access to the FDA-cleared accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol from BrainsWay for the treatment of Major Depressive Disorder (MDD), including cases with comorbid anxiety.




“Because Serenity already uses BrainsWay machines in its clinics, patients can now benefit immediately from this faster, convenient, and non-invasive treatment option,” said Tricia Pease, COO and co-founder of Serenity Mental Health Centers. “We are committed to being the best TMS clinic in Colorado Springs.”

Serenity’s board-certified psychiatrists and psychiatric mental health nurse practitioners provide full-spectrum mental health services tailored to each patient’s needs. Treatments include psychiatric evaluations, medication management, TMS, and ketamine treatment for conditions such as depression, anxiety, PTSD, OCD, and more. These evidence-based approaches are designed for patients seeking both traditional support and non-medication treatment options.

Serenity’s outpatient model includes flexible scheduling and same-day appointments, breaking down barriers that often prevent patients from receiving timely care. Serenity is committed to providing patient-first psychiatry and to becoming the go-to destination for TMS therapy in Colorado Springs.

With an 84% response rate and 78% remission rate for TMS patients, Serenity is considered one of the best TMS clinics in Colorado Springs for those seeking alternatives to medication.

To book an appointment, visit https://serenitymentalhealthcenters.com/colorado-springs/ or call 719-414-2331.

About Serenity Mental Health Centers

Serenity Mental Health Centers is a leading provider of comprehensive mental health services, dedicated to transforming the lives of patients through compassionate, innovative, and evidence-based care. With 35 locations across the country, Serenity offers a wide range of treatments tailored to address various mental health conditions, including depression, anxiety, OCD and PTSD. Our highly skilled team of psychiatrists, nurse practitioners and mental health specialists combine innovative therapies like Transcranial Magnetic Stimulation (TMS) and ketamine infusion with personalized care to help patients achieve lasting wellness. Serenity is committed to expanding access to quality mental health care and fostering hope and recovery for individuals and families in the communities we serve. For more information, go to serenitymentalhealthcenters.com.

Contacts

For more information, contact:
Jillian DiMarco

jdimarco@serenityhealthcare.com

Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition

Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition




Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to Pfizer’s pending acquisition of Metsera (NASDAQ: MTSR).


The termination of the waiting period under the HSR Act satisfies the regulatory review requirements under the previously announced proposed acquisition of Metsera, which was set to expire on November 7.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of October 31, 2025. This release contains forward-looking information about, among other topics, Pfizer’s proposed acquisition of Metsera that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks and uncertainties related to the impact of Novo Nordisk’s proposal on the proposed acquisition; risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain the requisite vote by Metsera stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made or accepted; the risk that the merger agreement may be terminated; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships, including Metsera’s ability to attract and retain highly qualified management and other clinical and scientific personals; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s or Metsera’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Metsera’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of Metsera’s pipeline products or Pfizer’s commercialized and/or pipeline products; risks associated with Metsera conducting clinical trials and preclinical studies outside of the United States; Metsera’s reliance on third parties to conduct clinical trials and preclinical studies and for the manufacture and shipping of its product candidates; the risk that Metsera’s product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with Metsera’s license and collaboration agreements and future strategic alliances; Metsera’s ability to obtain, maintain, defend and enforce patent or other intellectual property protection for current or future product candidates or technology; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for Pfizer’s or Metsera’s pipeline products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of such products; uncertainties regarding the impact of COVID-19; and competitive developments.

You should carefully consider the foregoing factors and the other risks and uncertainties that affect Pfizer’s business described in the “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” sections of Pfizer’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the U.S. Securities and Exchange Commission, all of which are available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Pfizer assumes no obligation to, and does not intend to, update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Pfizer does not give any assurance that it will achieve its expectations.

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com
Investor Contact: IR@Pfizer.com