#jobs #lifescience Paramount Recruitment: Neuroscience Software Engineer/Scientist (Barcelona)

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Paramount Recruitment: Neuroscience Software Engineer/Scientist (Barcelona) .
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Neuroscience Software Engineer/Scientist (Barcelona)

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#jobs #lifescience Paramount Recruitment: Software Engineer (Python – Cambridge)

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#jobs #lifescience Paramount Recruitment: Software Test Automation Engineer

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#jobs #lifescience Paramount Recruitment: Front End Software Engineer (Barcelona)

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#jobs #lifescience Paramount Recruitment: Quality and Regulatory Manager

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#jobs #lifescience Paramount Recruitment: Senior Software Engineer (Python – Cambridge)

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#jobs #lifescience Imperial College London: Instrument Engineers – Space (Multiple Posts)

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Imperial College London: Instrument Engineers – Space (Multiple Posts) .
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Enanta Announces European Commission Grants AbbVie Marketing Authorization for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

  • MAVIRET is a new, 8-week, pan-genotypic treatment for hepatitis C
    patients without cirrhosis and who are new to treatment
    *
  • Marketing authorization is supported by a 97.5 percent cure**
    rate across this group of patients
    1
  • MAVIRET is approved for use in HCV patients who also have chronic
    kidney disease
    1
  • Glecaprevir, one of the two new direct-acting antivirals (DAAs) in
    MAVIRET, is Enanta’s second protease inhibitor being developed and
    commercialized by AbbVie

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that the European Commission (EC) has granted AbbVie marketing
authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily,
ribavirin-free treatment for adults with chronic hepatitis C virus (HCV)
infection across all major genotypes (GT1-6). MAVIRET is a new, 8-week,
pan-genotypic treatment for patients without cirrhosis and new to
treatment*, who comprise the majority of the estimated 71 million people
worldwide living with HCV.2,3

MAVIRET is also indicated for patients with specific treatment
challenges, including those with compensated cirrhosis across all major
HCV genotypes, and those who previously had limited treatment options,
such as patients with severe chronic kidney disease (CKD) or those with
genotype 3 chronic HCV infection.1 MAVIRET is the only
pan-genotypic treatment approved for use in patients across all stages
of CKD.1

Following this marketing authorization of MAVIRET in the European Union
(E.U.), Enanta expects to receive a $25 million milestone payment from
AbbVie.

“This authorization means that MAVIRET now has the opportunity to
address the majority of HCV patients in Europe with a simple,
pan-genotypic, 8-week treatment option, and is also approved for use in
patients across all stages of CKD,” stated Jay R. Luly, Ph.D., President
and CEO, Enanta. “We are thrilled to have our second protease inhibitor
approved and be part of this exciting new HCV regimen.”

The approval of MAVIRET is supported by data from eight registrational
studies in AbbVie’s clinical development program, which evaluated more
than 2,300 patients in 27 countries across all major HCV genotypes
(GT1-6) and special populations.

EC authorization is supported by data from AbbVie’s registrational
studies showing a combined 97.5 percent (n=779/799)† cure** rate with
just 8 weeks of treatment in GT1-6 patients without cirrhosis and new to
treatment.1 This high cure rate was achieved in patients with
varied patient and viral characteristics and including those with CKD.1
For compensated cirrhotic patients, a 98 percent (n=201/205)‡ cure rate
was achieved with 12 weeks of treatment.1 For GT3
treatment-experienced patients with or without compensated cirrhosis, a
96 percent (n=66/69) cure rate was achieved with 16 weeks of treatment.1
In registrational studies for MAVIRET, less than 0.1 percent of patients
discontinued treatment due to adverse reactions.1 The most
commonly reported adverse reactions (incidence greater than or equal to
10 percent) were headache and fatigue.1

MAVIRET combines two new, potent‡‡ direct-acting antivirals
that target and inhibit proteins essential for the replication of the
hepatitis C virus. The presence of most genotypes or baseline mutations
that are commonly associated with resistance have been shown to have
minimal impact on the efficacy of MAVIRET.

EC authorization follows the European Medicines Agency’s review of
MAVIRET under accelerated assessment, which is granted to new medicines
of major public health interest. AbbVie’s MAVIRET treatment is now
licensed for use in all 28 member states of the E.U., as well as
Iceland, Liechtenstein and Norway. AbbVie’s investigational,
pan-genotypic regimen has also been granted accelerated review
designations by other regulatory authorities, including the U.S. Food
and Drug Administration and the Japanese Ministry of Health, Labour and
Welfare.

*Patients without cirrhosis and new to treatment [either treatment-naive
or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or
SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic
response at 12 weeks post treatment (SVR12) are considered cured of
hepatitis C.
†Data were pooled from 8-week arms of the ENDURANCE-1
and 3, and SURVEYOR-2 studies.
‡Data were pooled from 12-week GT3
treatment-naive, compensated cirrhotic arm of the SURVEYOR-2 and
EXPEDITION-1 studies.
‡‡ Based on EC50 values of glecaprevir and
pibrentasvir against full-length or chimeric replicons encoding NS3 or
NS5A from laboratory strains and chimeric replicons from clinical
isolates.1

About MAVIRET® (glecaprevir/pibrentasvir)
MAVIRET® is
approved in the European Union for the treatment of chronic hepatitis C
virus (HCV) infection in adults across all major genotypes (GT1-6).
MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that
combines glecaprevir (100mg), an NS3/4A protease inhibitor, and
pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.

MAVIRET is an 8-week, pan-genotypic option for patients without
cirrhosis and new to treatment*, who comprise the majority of people
living with HCV. MAVIRET is also approved as a treatment for patients
with specific treatment challenges, including those with compensated
cirrhosis across all major genotypes, and those who previously had
limited treatment options, such as patients with severe chronic kidney
disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is
a pan-genotypic treatment approved for use in patients across all stages
of CKD.

EU Indication
MAVIRET is indicated for the treatment of
chronic hepatitis C virus (HCV) infection in adults.

Important EU Safety Information
Contraindications:
MAVIRET
is contraindicated in patients with severe hepatic impairment
(Child-Pugh C). Concomitant use with atazanavir-containing products,
atorvastatin, simvastatin, dabigatran etexilate, ethinyl
oestradiol-containing products, and strong P-gp and CYP3A inducers, such
as rifampicin, carbamazepine, St. John’s wort, phenobarbital, phenytoin,
and primidone.

Special warnings and precautions for use:
Hepatitis B
virus reactivation

Cases of hepatitis B virus (HBV)
reactivation, some of them fatal, have been reported during or after
treatment with direct-acting antiviral agents. HBV screening should be
performed in all patients before initiation of treatment.

Hepatic impairment
MAVIRET is not recommended in patients
with moderate hepatic impairment (Child Pugh-B).

Patients who failed a prior regimen containing an NS5A- and/or an
NS3/4A-inhibitor

MAVIRET is not recommended for the
re-treatment of patients with prior exposure to NS3A/4A and/or
NS5A-inhibitors.

Adverse Reactions
Most common (≥10 %) adverse reactions for
MAVIRET were headache and fatigue.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV). Enanta has also discovered novel protease inhibitors that
have been developed as part of AbbVie’s hepatitis C virus (HCV)
treatment regimens under a collaboration that now provides Enanta a
payment stream, which it is using to fund its research and development
programs. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

FORWARD LOOKING STATEMENTS
This press release contains
forward-looking statements, including statements with respect to the
prospects for commercialization of MAVIRET in the E.U. and the prospects
for commercialization regulatory approval for MAVIRET in other
jurisdictions. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and projections
about Enanta’s business and the industry in which it operates and
management’s beliefs and assumptions. The statements contained in this
release are not guarantees of future performance and involve certain
risks, uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from what
is expressed in such forward-looking statements. Important factors and
risks that may affect actual results include: the efforts of AbbVie (our
collaborator developing MAVIRET) to commercialize MAVIRET successfully
in the E.U. and to obtain regulatory approvals of the
glecaprevir/pibrentasvir (G/P) combination and commercialize it
successfully in other jurisdictions; the regulatory and marketing
efforts of others with respect to competitive treatment regimens for
HCV; regulatory and reimbursement actions affecting MAVIRET, any
competitive regimen, or both; the need to obtain and maintain patent
protection for glecaprevir and avoid potential infringement of the
intellectual property rights of others; and other risk factors described
or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2016 and other periodic reports
filed more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.

1 MAVIRET® tablets (glecaprevir/pibrentasvir) Summary of
product characteristics. Maidenhead, UK. AbbVie, Ltd.
2
Decisions Resources Group. Hepatitis C virus: disease landscape &
forecast 2016. January 2017.
3 World Health
Organization. Global Hepatitis Report 2017. http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1.

Contacts

Investor Contact
Enanta Pharmaceuticals
Carol Miceli,
617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

#jobs #lifescience National Physical Laboratory (NPL): Higher or Senior Research Scientist Optical Cavity and Ultra-Stable Laser Development – Teddington

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: National Physical Laboratory (NPL): Higher or Senior Research Scientist Optical Cavity and Ultra-Stable Laser Development – Teddington .
£31,500 – £43,000:

National Physical Laboratory (NPL):
The UK`s National Physical Laboratory sits at the intersection between scientific discovery and real world application as one of the…
Teddington

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#jobs #lifescience De La Rue: Product Steward – Overton, Basingstoke

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: De La Rue: Product Steward – Overton, Basingstoke .
Competitive Salary:

De La Rue:
We are looking for a capable and determined Product Steward who is seeking an intellectual challenge in a…
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