The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Biohaven Pharmaceutical, a clinical-stage biopharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 505 (b) (2) new drug application (NDA) for Nurtec (riluzole) for treating...
Strides Pharma, a Bangalore, India-based pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) for violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals...
Celltrion, an Incheon, Korea-based biopharmaceutical company developing innovator drugs and biosimilars, and Nan Fung Group, a Hong Kong-based conglomerate, have formed a joint-venture company, Vcell Healthcare, to develop biosimilars in China....
The US Food and Drug Administration (FDA) has approved multiple applications for first generics of Pfizer’s blockbuster drug, Lyrica (pregabalin), for treating neuropathic pain and epilepsy. The approvals were granted to Teva Pharmaceuticals, Dr....
Astellas Pharma has entered into an exclusive license agreement, worth up to $625 million, with Frequency Therapeutics, a biopharmaceutical company focused on small-molecule drugs, to develop and commercialize Frequency Therapeutics’ regenerative...
Sanofi has signed an agreement with Roche for the exclusive over-the-counter (OTC) rights in the US to Roche’s Tamiflu (oseltamivir phosphate) for the prevention and treatment of influenza. Tamiflu is currently sold in the United States by Roche’s...
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the US at the patient level due to mislabeling of certain vials. Certain vials from these two lots were labeled as Kogenate FS but actually...
Gilead Sciences has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Novartis will receive an upfront payment and is...
Boehringer Ingelheim (BI) has entered into a collaboration and license agreement, in a deal worth up to in up EUR 1.1 billion ($1.2 billion), with Bridge Biotherapeutics, a clinical-stage biopharmaceutical company, to develop Bridge...
Yellow Wood Partners, a Boston-based private investment firm, has entered into a definitive agreement to buy the Dr. Scholl’s business, consisting of foot-care products, from Bayer for $585 million. Bayer says that the divestiture will enable it to...
Roche and Spark Therapeutics have agreed to amend their agreement for their $4.3-billion merger to allow for a closing date through April 30, 2020 from January 31, 2020. The move follows an earlier request by the US Federal Trade Commission (FTC)...
Gilead Sciences and Galapagos, a Mechelen, Belgium-based pharmaceutical company focused on small-molecules drugs in inflammation, fibrosis, and osteoarthritis, have entered into a 10-year global research and development collaboration in a deal...
Kite, a Gilead Sciences biopharmaceutical company for cancer immunotherapies, has announced plans for a 67,000-square-foot facility in Oceanside, California for the development and manufacturing of viral vectors. Viral vectors are a starting...
Boehringer Ingelheim (BI) has agreed to acquire Amal Therapeutics, a private Swiss biotechnology company developing cancer immunotherapies and therapeutics cancer vaccines, for a total transaction value of EUR 325 million ($365 million) consisting...
PL Developments (PLD), a manufacturer, packager and distributor of over-the-counter (OTC) pharmaceutical products, has acquired Teva Pharmaceuticals’ US store-brand portfolio, which includes Teva’s nicotine chewing gum.
The acquisition will add a...
