Biopharma News

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

A new study published in JAMA Internal Medicine found that manufacturers do not report a portion of adverse events to FDA within the federally mandated time frame of 15 days.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

 Teva announced that it has signed a definitive agreement to acquire the generic-drug business of Allergan in a transaction valued at $40.5 billion. The deal is expected to close in the first quarter of 2016.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.

The PD-1 inhibitor was approved as a first-line therapy and for previously treated patients with advanced melanoma.

The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.

Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

Sanofi's new business-unit structure focuses on growth drivers.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

The acquisition will bolster Celgene’s immunotherapy pipeline.

This collaboration is said to be the first established between the Crick and a pharmaceutical company.

 The United States Treasury Department introduced policy in September 2014 to discourage companies from merging with foreign companies in another fiscal jurisdiction to escape tax responsibilities. The policy was enacted to make inversion more difficult and to curb a company’s acquisition of a related foreign company for the sole purpose of avoiding United States corporate tax rates.

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.