The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA)’s Center for Drug Evaluation and Research (CDER), featuring NME approvals from Bayer, Merck & Co., Daiichi, Shield Therapeutics and...
Perrigo, a pharmaceutical company of generic drugs and over-the-counter (OTC) products, specified in its second-quarter 2019 results that it has not set a specific date for its previously announced plan to separate its prescription pharmaceuticals...
A federal district court judge has ruled against Sandoz, the generics business of Novartis, in patent litigation relating to Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug, Enbrel (etanercept), an anti-inflammatory drug with...
Senator Chuck Grassley (R-IA), Chairman of the US Senate Finance Committee, has submitted a letter to US Department of Health and Human Services’ (HHS) Secretary Alex Azar and the US Food and Drug Administration’s (FDA) Acting Commissioner Norman...
GlaxoSmithKline’s (GSK) President of US Pharmaceuticals, Jack Bailey, has decided to step down from his role at the end of 2019. GSK has appointed Maya Martinez-Davis, currently Regional President, Latin America Region at EMD Serono, to succeed...
The US Food and Drug Administration (FDA) has issued a statement addressing product-testing data used to support the production process in the biologics license application (BLA) for Novartis’ Zolgensma (onasemnogone abeparvovec-xioi), a gene...
Boehringer Ingelheim (BI) and the University of Texas MD Anderson Cancer Center have formed a multi-year partnership to conduct collaborative research on therapies for various types of cancers, including the establishment of a joint Virtual...
Bayer has agreed to acquire BlueRock Therapeutics, a developer of cell therapies in neurology, cardiology and immunology, in a deal worth up to $600 million. BlueRock develops engineered cell therapies using a proprietary induced pluripotent stem...
Mallinckrodt, a specialty pharmaceutical company, has announced the company is suspending for now its previously announced plans to spin off its specialty generics business into a stand-alone company based on current market conditions and...
Vertex Pharmaceuticals has announced that its Board of Directors has approved the planned transition of Reshma Kewalramani, MD, its current Chief Medical Officer, to become President and Chief Executive Officer (CEO) and to serve on Vertex’s Board...
Sosei Heptares, a Tokyo-headquartered pharmaceutical company, has entered into a strategic multi-target partnership with Takeda Pharmaceutical to discover, develop and commercialize small molecules and biologics that modulate G protein-coupled...
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 July 31, 2019 to September 3, 2019.
Roche extended the offer period to provide...
Pfizer has completed the closing of its joint venture with GlaxoSmithKline (GSK) that combines the companies’ respective consumer healthcare businesses. Pfizer owns a 32% equity stake in the joint venture and GSK 68%. The combined business, which...
Novartis has announced that the Superior Court of Quebec has granted Sandoz Canada the right to buy back its former sterile-manufacturing facility in Boucherville, Quebec, Canada. The site has been under receivership, and as an interim measure, the...
The US Department of Health and Human Services (HHS) has announced that it and the US Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways for the safe importation of certain drugs...
