The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
Bristol-Myers Squibb and Celgene have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion.
“Together with Celgene, we...
Eli Lilly and Company and AC Immune SA, a Lausanne, Switzerland-based biopharmaceutical company, have formed an agreement to research and develop tau aggregation inhibitor small molecules for the potential treatment of Alzheimer's disease (AD) and...
Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, has announced it will move forward as an independent company following a decision from the Supreme Court of the State of Delaware to allow Fresenius Kabi AG, a...
The US Food and Drug Administration (FDA) has released two guidances, one final and one draft, to advancie the agency’s biosimilars policy framework. The guidances describe the agency’s plan to implement Congress’ direction that the FDA transition...
Gilead Sciences has appointed Daniel O’Day, currently Chief Executive Officer (CEO) of Roche Pharmaceuticals, as Chairman of the Board of Directors and CEO of Gilead, effective March 1, 2019. John C. Martin, current Chairman, Gilead Sciences’ Board...
The US Food and Drug Administration (FDA) is withdrawing a proposed rule from 2013 that, if finalized, would have allowed generic drug makers to independently—meaning, without prior FDA review and approval—update and promptly distribute new safety...
The US Food and Drug Administration (FDA) has issued final guidance, Data Integrity and Compliance With Drug CGMP, which updates a 2016 guidance for ensuring data integrity and compliance with current good manufacturing practice (CGMP), in response...
Boehringer Ingelheim (BI) has announced staff reductions in France as part of a post-integration plan of Sanofi’s animal-health business (Merial), which BI acquired in 2017. The reorganization includes the elimination of 327 positions (197 in human...
