The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
AveXis, a Novartis company, has received approval from the US Food and Drug Administration (FDA) for Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy for pediatric patients with spinal muscular atrophy (SMA), a rare neuromuscular...
Eli Lilly and Company has entered into a licensing agreement with Centrexion Therapeutics, a late-clinical stage biopharmaceutical company, to acquire the exclusive global rights for CNTX-0290, a potential non-opioid treatment for chronic pain...
Merck & Co. has entered into a definitive agreement with Peleton Therapeutics, a clinical-stage biopharmaceutical company, under which Merck, through a subsidiary, will acquire all outstanding shares of Peleton for $1.05 billion upfront plus a...
Roche’s Genentech has entered into a global collaboration and licensing agreement with Parvus Therapeutics, a privately held biopharmaceutical company, to develop, manufacture and commercialize Navacim therapeutics for treating autoimmune...
Civica Rx, a pharmaceutical company providing drugs in shortage, and Xellia Pharmaceuticals, a specialty pharmaceutical company specializing in anti-infectives, have signed a product supply agreement under which Xellia will manufacture essential...
The US Food and Drug Administration (FDA) has issued final guidance, Considerations in Demonstrating Interchangeability With a Reference Product, on the pathway for “interchangeable” biologics. The final guidance on interchangeability will provide...
Novartis has announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension, a bone marrow stimulant, to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour...
B. Braun Medical, which develops, manufactures, and markets products for infusion therapy and pain management, has announced a $1-billion investment in new and enhanced IV therapy manufacturing facilities. The investments include a new...
Nestlé has entered into exclusive negotiations with a consortium led by the private equity firm, EQT, and a wholly owned subsidiary of the Abu Dhabi Investment Authority (ADIA) for the sale of Nestlé Skin Health for a value of CHF 10.2 billion...
Pfizer has agreed to acquire Therachon Holding AG, a Basel, Switzerland-based clinical-stage biotechnology company focused on rare diseases, in a deal with up to $810 million.
Under the terms of the agreement, Pfizer will acquire Therachon for...
Pizer has opened a new 175,000-square-foot manufacturing facility in Andover, Massachusetts to support manufacture of clinical supplies for the company’s BioTherapeutics Pharmaceutical Sciences organization. Pfizer’s Andover site houses commercial...
Bayer has announced that it will invest $150 million in its pharmaceutical development and manufacturing site in Berkeley, California to build a Cell Culture Technology Center that will be used to support Bayer's portfolio of biologics.
The new...
Novo Nordisk has announced a plan, beginning in early 2020, to have its global production to be completely powered by renewable electricity, with a 10-year goal of achieving zero carbon emissions from operations and transportation.
The...
H. Lundbeck A/S, a Valby, Denmark biopharmaceutical company, has agreed to acquire Abide Therapeutics, a San Diego, California-based clinical-stage biopharmaceutical company, for $250 million upfront and up to $150 million in future development and...
Novartis has entered into an agreement with Takeda Pharmaceutical to acquire the assets associated with Xiidra (lifitegrast ophthalmic solution), a prescription drug for treating dry eye, for $3.4-billion upfront and up to $1.9 billion in potential...
