Biopharma News

The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.

Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.

The companies will partner to develop T-cell therapies for cancer.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.

The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.