The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Lupin a Mumbai, India-based pharmaceutical company, has agreed to sell its entire stake in its Japanese subsidiary, Kyowa Pharmaceutical Industry Co., for JPY 57.4 billion ($527 million) to the private-equity firm, Unison Capital Partners. The...
A roundup of developments and latest news from India (Aurobindo, Biocon) and the US (Cosette Pharmaceuticals).
India
FDA Issues Form 483 to Aurobindo API Mfg Facilities in India
The US Food and Drug Administration (FDA) has issued a Form 483...
The US Food and Drug Administration (FDA) has approved Celgene’s and Acceleron’s Pharma Reblozyl (luspatercept-aamt) for treating anemia in adult patients with beta thalassemia, a rare blood disorder, who require red-blood-cell transfusions....
Novartis’ Sandoz has agreed to acquire the Japanese business of Aspen Global Inc. (AGI), a wholly owned subsidiary of the specialty and branded pharmaceutical company, Aspen Pharmacare, for up to EUR 400 million ($440 million). Aspen’s portfolio in...
Biogen has proposed a new $310-million transaction with Samsung Bioepis, a biosimilar biopharmaceutical joint venture between Samsung BioLogics and Biogen, for the exclusive rights to commercialize two new ophthalmology biosimilars, SB11...
AstraZeneca has announced three large-scale initiatives in China to advance global research and development (R&D) for innovative new medicines. The company is creating a new global R&D center and an artificial intelligence (AI) innovation...
Endo International, a generics and specialty branded pharmaceuticals company, has announced that Paul V. Campanelli, President and Chief Executive Officer (CEO) has notified the company’s Board of Directors of his intention to retire, and the Endo...
Takeda Pharmaceutical has agreed to divest a portfolio of 20 select products to Stada Arzneimittel, a generics and specialty pharmaceuticals company, for a total value of $660 million. The portfolio includes over-the-counter and prescription...
Sandoz, a Novartis Company, has received US Food and Drug Administration (FDA) approval for its biosimilar, Ziextenzo (pegfilgrastim-bmez), the biosimilar to Amgen’s Neulasta (pegfilgrastim), for treating febrile neutropenia. Neulasta is one of...
The US Food and Drug Administration (FDA) has placed a partial hold on clinical trials for the intrathecal administration of Novartis’ Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy, or AVXS-101.
AveXis, a Novartis company, is studying...
A roundup of developments and latest news from Germany (AstraZeneca, Takeda) and India (Zydus Cadila).
Europe
AstraZeneca to Divest Rights to Cheplapharm for Seroquel Products in EU and Russia
AstraZeneca has agreed to the sale and license of...
President Donald J. Trump has announced his intent to nominate Dr. Stephen Hahn, Chief Medical Executive at the University of Texas MD Anderson Cancer Center (MDACC), to be the next Commissioner of the US Food and Drug Administration (FDA). He...
Roche has formed a research collaboration and licensing agreement with Dicerna Pharmaceuticals, a developer of RNAi medicines, in a deal worth up to $1.67 billion focused on developing treatments for hepatitis B virus (HBV) infection.
Under the...
Bayer has completed the sale of its Dr. Scholl’s consumer footcare business to Yellow Wood Partners, a Boston-based private investment firm, for a purchase price of $585 million.
Dr. Scholl’s generated sales of $234 million in 2018. Yellow Wood...
Amgen has entered into a global strategic oncology collaboration with BeiGene, a Beijing-headquartered company, under which Amgen will acquire an equity stake in BeiGene for approximately $2.7 billion.
The companies will collaborate for the...
