The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Senate Committee on Health, Education, Labor & Pensions (HELP) held a confirmation hearing this week (November 20, 2019) for President Donald Trump’s nominee for the US Food and Drug Administration’s (FDA) Commissioner, Dr. Stephen Hahn....
Mylan and Pfizer have announced Viatris as the name of the new company to be formed by the planned combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, which was announced earlier this year...
The US Food and Drug Administration (FDA) has approved Pfizer’s Abrilada (adalimumab-afzb) as a biosimilar to AbbVie’s blockbuster drug, Humira (adalimumab), an anti-inflammatory drug. Abrilada has been approved for the treatment of patients with...
Eli Lilly and Company has announced plans to invest $400 million in its manufacturing facilities at its Lilly Technology Center campus in Indianapolis, Indiana. The investment includes enhancements to existing manufacturing facilities that make...
Roche has agreed to acquire Promedior, a Lexington, Massachusetts-based clinical-stage biopharmaceutical company with a portfolio of molecules for treating serious fibrotic diseases, in a deal worth up to $1.4 billion.
Under the agreement, Roche...
Novo Nordisk and Dicerna Pharmaceuticals, a biopharmaceutical company specializing in ribonucleic acid interference (RNAi) therapies, have formed a collaboration to discover and develop therapies for treating liver-related cardio-metabolic...
Bristol-Myers Squibb (BMS) has completed its $74-billion acquisition of Celgene following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by...
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...
