The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Food and Drug Administration (FDA) has approved Amgen’s and Allergan’s biosimilar of Roche’s Herceptin (trastuzumab). Their biosimilar, Kanjinti (trastuzumab-anns), was approved for the treatment of HER2-overexpressing adjuvant and...
Vertex Pharmaceuticals has made two deals, worth up to $1 billion each, to enhance its gene-editing capabilities in drug development. The company is expanding its collaboration with CRISPR Therapeutics, a gene-editing company developing gene-based...
Amgen, along with Merck and Co., Eli Lilly and Company, and the Association of National Advertisers, have filed suit against the US Department of Health and Human Services’ (HHS) regarding a recent HHS rule requiring list prices to be included for...
Pfizer has entered into a merger agreement with Array BioPharma, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule medicines for cancer and other diseases, for a total...
Genmab, a biotechnology company specializing in antibody therapeutics for the treatment of cancer, has entered into a worldwide license and option agreement with Janssen Biotech, part of Johnson & Johnson, to develop and commercialize...
Boehringer Ingelheim (BI) has opened a new production plant in Sant Cugat del Valles, Spain, to produce and package Respimat, an inhalation device for patients with asthma and chronic obstructive pulmonary disease (COPD).
BI invested more than EUR...
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...
