A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
The global biopharma is using Reify Health’s StudyTeam software to streamline and automate clinical trial functions, including recruiting and enrollment.
Amgen and Takeda will join fellow big pharma companies Sanofi, GSK, and Janssen, in working to progress Feldan’s intracellular drug delivery technology.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
A restructuring programme which closed two US facilities and slashed hundreds of jobs has paid off says Amgen, attributing increased margins to better manufacturing efficiencies.
Amgen has retracted a study showing how grizzly bears could hold the key to understanding diabetes after one of the authors was found to have manipulated data.
Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information...
A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.
Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
Researchers from Amgen have published results detailing a method
that improves the analysis of the sugar groups attached to
monoclonal antibodies (MAbs) and proteins.
Amgen has announced the 'indefinite postponement' on plans for its
$1bn (€0.71bn) manufacturing facility in Cork, Ireland, following
further navel gazing by the company.
A US judge has backed Amgen's court motion, ruling that Roche's
Mircera infringes one of its composition patents. Roche is standing
firm against the allegations.
Amgen is rushing to discover how interleukin-17 causes
inflammation and bone destruction in rheumatoid arthritis, as it
could provide a valuable new therapeutic target.
Swiss drug major Roche is facing a delay in bringing its EPO drug
Mircera (continuous erythropoietin receptor activator) to market in
the US after the Food and Drug Administration sent it an
'approvable' notice for the product.
The decision of the US Supreme Court not to hear Amgen's appeal in
a patent infringement case against Sanofi-Aventis and Shire,
involving the anaemia drug Epogen (epoetin alfa), may weaken
Amgen's position in keeping another...
Biotech giant Amgen has posted healthy results for the first
quarter following a positive performance by its blockbuster anaemia
drug Aranesp (darbepoetin alfa).
Predix Phamaceuticals has formed a collaboration with Amgen in a
deal that aims to develop S1P1 modulators for the treatment of
autoimmune diseases. The agreement has the potential to become a
$300m (€235m) payout for Predix.
Biotechnology company, Amgen, and Biovitrum have expanded its
existing license agreement for its treatment of metabolic
disorders, focusing on type 2 diabetes, which currently afflicts
over 160 million people worldwide.
Responding to growing demand, Biotechnology giant Amgen has
announced an expansion of its manufacturing facilities in Puerto
Rico, investing $1 billion (€835 million) in the project over the
next four years.
Amgen are to create a European Development Centre in the UK,
significantly increasing UK R&D employee numbers. Amgen's
announcement echoes the UK Government's commitment to attract more
R&D investment with a view...
Amgen are to create a European Development Centre significantly
boosting UK drug R&D. The announcement echoes the UK
Government's commitment to attract more R&D investment with a
view to making the UK a leader in biotechnology.
Pharmaceutical companies are set to face stiff competition, as
generic forms of best-selling biologic drugs will capture a
significant market share. The expiration of drug patents, which
expire within the next few years, opens up...
Two $500m-plus licensing deals reveal the rewards available to
biotech firms with novel drugs, but also the lengths large
biopharma companies will now go to secure exclusive rights to
promising candidates, even if they are in the...