The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Biogen has completed its previously announced acquisition of Nightstar Therapeutics (NST), a clinical-stage gene therapy company based in London, for a total transaction value of approximately $800 million, taking into account expected transaction...
The Discovery Labs, a platform company that develops co-working laboratory and office space for healthcare, life sciences and technology-enabled companies, has announced it is redeveloping a pair of sites in Pennsylvania, the former...
Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, reports that the US Food and Drug Administration (FDA) has issued 11 observations following an inspection of the company’s manufacturing facilities in St. Louis, Missouri. The...
The US Food and Drug Administration (FDA) is opening a public docket to gain public input on the potential of requiring certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use, blister packaging.
The FDA is...
Iovance Biotherapeutics, a late-stage biotechnology company specializing in immunotherapies for cancer, has entered into a lease agreement to build a 136,000 square-foot cell-therapy production facility in Philadelphia, Pennsylvania for commercial...
Boehringer Ingelheim (BI) and Gubra, a provider of contract services for drug discovery and development, have entered into a collaboration and license agreement for the development of poly-agonist peptides to treat obesity. This new research and...
Mallinckrodt, a specialty pharmaceutical company, has updated its plans to create two independent, publicly traded companies: one focused on innovative specialty branded pharmaceuticals and the other concentrated primarily in specialty generic...
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...
