The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Krigen Pharmaceuticals, a privately held Indian pharmaceutical company, is investing $7 million in a new US manufacturing facility in Lillington, North Carolina. Krigen will manufacture IV bags and liquid injectables in a new 55,000-square-foot...
The US Food and Drug Administration (FDA) has approved Roche’s Polivy (polatuzumab vedotin-piiq) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Polivy was...
Athenex, a pharmaceutical company specializing in the discovery, development and commercialization of cancer therapies, has voluntarily suspended production activities at its active pharmaceutical ingredient (API) plant in China.
The...
Merck and Co. has agreed to acquire Tilos Therapeutics, a biopharmaceutical company developing therapeutics targeting the latent TGFβ complex against cancer, fibrosis and autoimmune diseases, in a deal valued up to $773 million. Merck, through a...
Sanofi has announced that its current Chief Executive Officer (CEO) Olivier Brandicourt plans to retire, effective September 1, 2019, and has named Paul Hudson, most recently head of Novartis Pharmaceuticals, as Sanofi’s new CEO. With that move,...
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...
