The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Teva Pharmaceutical Industries has appointed John Nason, Teva’s Senior Vice President of European Technical Operations, as President, Teva Active Pharmaceutical Ingredients (TAPI), a role in which he will lead the company’s vertically integrated...
Mylan has purchased the worldwide rights to commercialize two of Novartis’ global cystic fibrosis products consisting of TOBI Podhaler (tobramycin inhalation powder) and TOBI solution (tobramycin inhalation solution), for approximately $463...
Lannett, a Philadelphia-headquartered generic drug manufacturer, has stopped expansion plans for its active pharmaceutical ingredient (API) manufacturing plant in Cody, Wyoming.
Lannett says the decision to stop expansion on the API plant owned by...
The US Food and Drug Administration (FDA) has published a draft guidance, Postapproval Changes to Drug Substances which discusses how the risk of one or more changes to a drug-substance manufacturing process during the drug-product application...
Novartis has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to Aurobindo Pharma USA for $1 billion, consisting of $900 million in cash plus $100...
Otsuka America Pharmaceutical, which received US Food and Drug Administration (FDA) approval for a so-called “smart pill” in 2017, has formed a partnership to support the marketing in the US of the drug–device combination product of Abilify...
The US Food and Drug Administration (FDA) has published an internal policy that outlines the agency’s risk-based, site-selection model for inspecting foreign drug-manufacturing facilities and has highlighted other ways in which the agency is...
The US Food and Drug Administration (FDA) has approved Merck & Co.’s two new HIV-1 medicines: Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300...
BioMarin, a San Rafael, California-based biopharmaceutical company, is investing $43 million in a new drug-product filling project at its Shanbally, County Cork, Ireland facility, according to information from IDA Ireland, a non-commercial,...
The US Food and Drug Administration (FDA) has provided an update on its investigation into an impurity found in certain samples of valsartan, which is used to treat high blood pressure and heart failure. The investigation began in June 2018 after a...
Emergent BioSolutions, a Rockville, Maryland-based specialty biopharmaceutical company and contract manufacturer, has agreed to acquire Adapt Pharma, a Dublin, Ireland-based specialty pharmaceutical company, and its leading product Narcan (naloxone...
Boehringer Ingelheim (BI) has broken ground to construct a new production facility for solid-dose drugs in Ingelheim am Rhein, Germany. This new solids launch facility will focus on development activities for drugs in tablet form and manufacture...
WuXi AppTec, a Shanghai, China-headquartered contract service provider, has appointed Edward Hu, the company’s Chief Financial Officer (CFO), as Co-Chief Executive Officer (CEO) of the company. Hu will continue to report to Dr. Ge Li, Chairman and...
The European Commission (EC) has approved Novartis’ Kymriah (tisagenlecleucel), a chimeric antigen receptor (CAR) T-cell therapy, for two indications in leukemia and lymphoma. Kymriah was the first CAR-T cell therapy approved by the US Food and...
Roche's Genentech is planning staff reductions of more than 200 at its biomanufacturing facility in San Mateo, California. The company reported the changes in an August 10, 2018 WARN (Worker Adjustment and Retraining Notification Act) filing with...
