The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Xellia Pharmaceuticals, a specialty pharmaceutical company focused on anti-infective treatments and globally headquartered in Copehangen, Denmark, has entered into an agreement to divest its Raleigh, North Carolina manufacturing plant to Sagent...
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has appointed Alessandro Riva, MD, as Chief Executive Officer of its new innovation company. Dr. Riva is currently Executive Vice President, Oncology Therapeutics and...
US Food and Drug Administration Commissioner Scott Gottlieb has announced that he will be leaving his post in the next month. He made the announcement on March 5 (2019) and cited family commitments as the reason for his departure.
“This is a very...
The US Food and Drug Administration (FDA) is updating the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic “sartan”-containing products, angiotensin II receptor blockers (ARBs), used to treat high blood...
Endo International, a generics and specialty branded pharmaceutical company, has announced that its subsidiaries, Endo Ventures Limited, Par Pharmaceutical, Inc. and Par Formulations Private Limited, have terminated their respective agreements to...
Novartis and Blackstone Life Sciences, a private investment firm, have launched Anthos Therapeutics, a new biopharmaceutical company focused on advancing targeted therapies for high-risk cardiovascular patients. The company will be based in...
Biogen has entered into an agreement to acquire Nightstar Therapeutics (NST), a clinical-stage gene- therapy company based in London, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Under the terms of...
Abpro, a Woburn, Massachusetts-based biotechnology company developing antibody therapeutics, and NJCTTQ, a pharmaceutical company based in Nanjing, China, have entered into an agreement to develop multiple bispecific antibody therapies in...
Amgen has received a favorable verdict from a jury from a federal district court in Delaware regarding two patents related to its anti-cholesterol drug, Repatha (evolocumab). Amgen has been involved in ongoing litigation with Sanofi and Regeneron...
The US Food and Drug Administration (FDA) has issued draft guidance, Quality Considerations for Continuous Manufacturing, to specify key quality considerations and provide recommendations for how applicants should address these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 to Acquire Spark Therapeutics for $4.3 Billion
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...
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...
