Biopharma News

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The acquisition would combine Sangamo’s ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

The company opened its new global headquarters in Japan.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

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.

The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.

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.