The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Food and Drug Administration (FDA) has issued draft guidance, Quality Considerations for Continuous Manufacturing, to specify key quality considerations and provide recommendations for how applicants should address these considerations in...
Ipsen, a pharmaceutical company headquartered in Paris, and Clementia Pharmaceuticals, a biopharmaceutical company headquartered in Montreal, have entered into an agreement for Ipsen to acquire Clementia for approximately $1.31 billion. The move...
Morphic Therapeutic, a biotechnology company developing oral integrin therapies, based in Waltham, Massachusetts, has entered into a research and development (R&D) collaboration with Janssen Biotech for over $725 million, if milestones are...
AbbVie and Voyager Therapeutics, a clinical-stage gene therapy company based in Cambridge, Massachusetts, have formed a strategic collaboration and option agreement to develop and commercialize vectorized antibodies for treating Parkinson’s disease...
Roche and Spark Therapeutics, a commercial gene-therapy company based in Philadelphia, have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics for $4.3 billion or $114.50 per share in an all-cash...
Merck & Co. and Immune Design, a late-stage immunotherapy company headquartered in Seattle, Washington, have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for $5.85 per share in cash for...
The US Food and Drug Administration (FDA) has issued a draft guidance to promote development and appropriate use of consensus standards in pharmaceutical quality and also has launched a pilot program to engage with the industry on post-approval...
The US Food and Drug Administration (FDA) has confirmed the capability of two additional European Union (EU) member states, Poland and Slovenia, to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US.
Poland and...
Allogene Therapeutics, a clinical-stage biotechnology company developing allogeneic chimeric antigen receptor T cell (CAR T) therapies for cancer, and headquartered in South San Francisco, California, has entered into a lease agreement to build a...
AveXis, a Novartis gene-therapy company headquartered in Bannockburn, Illinois, plans to invest an additional $60 million to expand its manufacturing center in Durham County, North Carolina to manufacture medicines for rare genetic diseases. Avexis...
SK Biopharmaceuticals, a pharmaceutical company based in Gyeonggi, South Korea, and Arvelle Therapeutics, a biopharmaceutical company based in Basel, Switzerland, have entered into an exclusive $530-million licensing agreement for Arvelle to...
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, plans to spin off its innovation business into a new company as a wholly owned subsidiary of Glenmark based in the US. The company’s Board of Directors has given an...
Roche’s Genentech and Xencor, a Monrovia, California-based clinical-stage biopharmaceutical company, have formed a research and license agreement to develop and commercialize IL-15 cytokine therapeutics in a deal worth up to $460 million.
Xencor...
Tris Pharma, a Monmouth Junction, New Jersey-based specialty pharmaceutical company, is expanding its voluntary recall of infant ibuprofen by adding three additional lots to its US recall. The recall applies to ibuprofen oral suspension drops, USP,...
Samsung Bioepis, a Incheon, Korea-based biosimilars company, has formed a licensing agreement for biosimilars in China with AffaMed Therapeutics, a newly formed biopharmaceutical company founded and funded by C-Bridge Capital, a private-equity firm...
