The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
In another recall of “sartan”-containing products, Teva Pharmaceuticals USA has expanded its voluntary recall to the consumer level in the US of losartan potassium tablets, used in antihypertensive drugs. The expanded recall includes six lots of...
Merck and Co. has been selected by the US Food and Drug Administration (FDA), along with Walmart, IBM, and KPMG, to participate in a pilot program in support of the US Drug Supply Chain Security Act (DSCSA) to identify, track and trace prescription...
Aurobindo Pharma, a manufacturer of generic pharmaceuticals and a contract manufacturer, has received a Form 483 with 10 observations, following an inspection by the US Food and Drug Administration (FDA) in May 2019 at the company’s formulation...
Roche and Spark Therapeutics, a commercial gene-therapy company based in Philadelphia, have received a request for additional information from the US Federal Trade Commission (FTC) regarding Roche’s pending $4.3-billion acquisition of Spark....
Luxembourg and the Netherlands have joined the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) inspections. The FDA has confirmed the capability of...
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...
