The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Sun Pharmaceutical Industries and Lupin Pharmaceuticals have issued separate voluntary recalls for select products due to particulate matter in vials.
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical...
Allergan has announced it will establish a research and development (R&D) site in Cambridge, Massachusetts.The site will be led by Don Frail, PhD, Senior Vice President of Research and External Scientific Innovation (RESI) and Non-Clinical and...
AstraZeneca has announced a reorganization of its research and development (R&D) and commercial units and has changed some of its executive management for those areas.
Under the new structure, AstraZeneca will form two R&D units: one...
Torrent Pharmaceuticals, an India-based pharmaceutical company, is expanding its voluntary recall from two lots of losartan potassium tablets USP to a total of 10 lots to the consumer level due to the detection of trace amounts of an...
Akorn, a specialty generic pharmaceutical company, reports that it has received a Warning Letter, dated January 4, 2019, from the US Food and Drug Administration (FDA) related to an inspection of its Decatur, Illinois manufacturing facility in...
Novartis has made an offer to acquire CellforCure, a contract development and manufacturing organization (CDMO) producing cell and gene therapies in Europe, from LFB, a French pharmaceutical company. The announcement was made December 20,...
Fujifilm Cellular Dynamics, Inc. (FCDI), a US subsidiary of Fujifilm Corporation and a developer and manufacturer of human induced pluripotent stem (iPS) cell technologies, has announced an investment of about $21 million to open a new...
Eli Lilly and Company has agreed to acquire Loxo Oncology, a Stamford, Connecticut-based biopharmaceutical company, for $235.00 per share in cash, or approximately $8.0 billion. Loxo Oncology is focused on the development and commercialization of...
Aurobindo Pharma USA, Inc., the US-based operations of Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredient manufacturer, is conducting a voluntary recall of 80 lots of amlodipine valsartan tablets USP,...
Teva Pharmaceutical Industries reports that it has resolved its ongoing dispute with Amgen over Teva’s generic cinacalcet HCl product. Teva and Amgen have been involved in patent-infringement litigation, and Teva recently received approval for, and...
Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, named Douglas S. Boothe as President and Chief Executive Officer (CEO), effective January 1, 2019. Most recently, Boothe served as the President of the generics...
Orchard Therapeutics, a Foster City, California-based clinical-stage biotechnology company, has signed a lease agreement to build-out a gene-therapy manufacturing facility in Fremont, California.
The new 150,000-square-foot facility adds to...
The US Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin (trastuzumab) from Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based pharmaceutical company. Herceptin...
Mallinckrodt, a specialty pharmaceutical company, plans to spin off a new company consisting of its specialty generics/active pharmaceutical ingredients (API) businesses and Amitiza (lubiprostone), a constipation drug to Mallinckrodt shareholders,...
GlaxoSmithKline (GSK) and Pfizer have agreed to combine their consumer health businesses into a new joint venture, with combined sales of approximately £9.8 billion ($12.7 billion). GSK will have a majority controlling equity interest of 68%, and...
