Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

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...

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...

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...

Mylan Pharmaceuticals is conducting a voluntary nationwide recall in the US of one lot of aprazolam tablets, USP C-IV 0.5 mg, to the consumer level due to the potential presence of foreign substance. Mylan says the clinical impact from the foreign...

Gilead Sciences and Glympse Bio, a developer of non-invasive technology for disease activity, have entered into a strategic collaboration for nonalcoholic steatohepatitis (NASH) clinical development. Glympse Bio’s proprietary synthetic biomarkers,...