The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
Roivant Sciences, a New York-based healthcare company, and Sumitomo Dainippon Pharma, have signed a definitive agreement for the creation of a broad strategic alliance and to form a new company owned and supported by Sumitomo Dainippon Pharma, in a...
The US Food and Drug Administration (FDA) has issued a report on the root causes and potential solutions for drug shortages, including proposing a new system to measure and rate the quality management maturity of manufacturing facilities. The new...
Johnson & Johnson (J&J) has reached an agreement in principle for $4 billion with certain state attorneys general over opioid litigation and has reduced its previously-reported third-quarter earnings to reflect the possible deal.
“Johnson...
Zentiva has agreed to acquire the Central and Eastern European (CEE) business of Alvogen, a provider of generics, biosimilars and over-the-counter (OTC) products, for an undisclosed amount. Zentiva is the former European generics business of...
Roche has extended its tender offer period relating to its pending $4.3-billion acquisition of Spark Therapeutics, a Philadelphia-based gene-therapy company, from October 30, 2019 to November 25, 2019. Roche had previously extended the offer period...
