The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Roche’s Genentech and Xencor, a Monrovia, California-based clinical-stage biopharmaceutical company, have formed a research and license agreement to develop and commercialize IL-15 cytokine therapeutics in a deal worth up to $460 million.
Xencor...
Tris Pharma, a Monmouth Junction, New Jersey-based specialty pharmaceutical company, is expanding its voluntary recall of infant ibuprofen by adding three additional lots to its US recall. The recall applies to ibuprofen oral suspension drops, USP,...
Samsung Bioepis, a Incheon, Korea-based biosimilars company, has formed a licensing agreement for biosimilars in China with AffaMed Therapeutics, a newly formed biopharmaceutical company founded and funded by C-Bridge Capital, a private-equity firm...
As part of its strategy to integrate digital technologies and medical science, Sanofi has named Ameet Nathwani, MD, as Chief Digital Officer in addition to his current role of Executive Vice President and Chief Medical Officer. As Chief Digital...
The US Food and Drug Administration (FDA) has approved Sanofi’s Cablivi (caplacizumab-yhdp) for treating thrombotic thrombocytopenic purpura (aTTP), a rare disease that causes blood clotting. The drug was approved in combination with plasma...
AbbVie and Teneobio, a Menlo Park, California-based biopharmaceutical company, and its affiliate TeneoOne, have entered into a global strategic transaction to develop and commercialize an immunotherapeutic for treating multiple myeloma.
TeneoBio...
The US Food and Drug Administration (FDA) has cited a formulations manufacturing plant in Bachupally, Hyderabad, India of Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, with the issuance of a Form 483 with 11...
The US Food and Drug Administration (FDA) has launched a new pilot program as part of its implementation of the Drug Supply Chain Security Act (DSCSA), a federal law that outlines steps to build an electronic, interoperable system to identify and...
Otsuka Pharmaceutical and Click Therapeutics, a New York-based developer of software as prescription medical treatments, have signed a collaboration agreement, worth up to $302 million, to develop and commercialize a prescription digital...
Progenics Pharmaceuticals, a New York-based company developing pharmaceuticals and imaging analysis technology for treating cancer, has acquired a manufacturing facility in Somerset, New Jersey for $8 million. The facility will serve as the launch...
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock issued a joint statement regarding the FDA’s ongoing investigation into impurities found in...
As part of the implementation of the European Union’s Falsified Medicines Directive, the European Medicines Agency (EMA) has highlighted that most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are...
The European Medicines Agency (EMA) has announced that companies that make “sartan” blood-pressure medicines (also known as angiotensin II receptor blockers) are now required to review their manufacturing processes so that they do not produce...
Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has formed a worldwide collaboration and license agreement, worth up to $440 million, with MeiraGTx, a New York- and London-based clinical stage...
Merck KGaA has announced a $70-million investment to expand its research and development (R&D) facility in Billerica, Massachusetts. The new building will span 145,000 square feet and provide new laboratory and collaborative working space to...
