Biopharma News

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.

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

Biomax Informatics AG and Pierre Fabre announced that they have entered into a collaboration to create an integrated antibody sequence and knowledge database.

GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.

The Canadian Green Cross facility will produce intravenous immunoglobulin and albumin.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.