The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has been awarded a $450-million contract from the US government to manufacture and supply REGN-COV2, Regeneron's investigational double antibody cocktail that is...
The latest on manufacturing and potential treatments for COVID-19 with news from Sanofi, Mylan, GSK, Moderna, CSL Behring, CureVac, Sinovac, Zydus Cadila, and the WHO.
News from Sanofi, Mylan, GSK, Moderna, CSL Behring
Sanofi, Regeneron End US...
Merck & Co. and Foghorn Therapeutics, a Cambridge, Massachusetts-based gene-therapy company, have formed a strategic collaboration, in a deal worth up to $425 million, to discover and develop therapeutics against a transcription factor target...
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has been awarded $1.6 billion by the US government to participate in Operation Warp Speed (OWS), a US government program that aims to begin delivering millions of doses of...
A roundup of news from Japan (Fujifilm), the UK (BI, Hikma, Perrigo) and the US (Nabriva Therapeutics, Lupin, Unichem, GSK, and La Jolla Pharmaceuticals).
Japan
Fujifilm Announces Approval of Adalimumab in JapanFujifilm Kyowa Kirin Biologics, a...
The latest on manufacturing and potential treatments for COVID-19 with news from AstraZeneca, Pfizer, Gilead Sciences, Daiichi Sankyo, Merck & Co., Merck KGaA, and others.
News from AstraZeneca, Daiichi Sankyo, Merck KGaA, Gilead, and Merck...
Takeda and Carmine Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company, have signed a research collaboration agreement to discover, develop and commercialize non-viral gene therapies for two rare disease targets, in a deal...
Novartis has voluntarily withdrawn its marketing authorization application (MAA) in the European Union for Xiidra (lifitegrast ophthalmic solution), a prescription drug for treating dry eye. Novartis had acquired the drug from Takeda last...
Allergan, an AbbVie Company, and Molecular Partners, a Zurich-based clinical-stage biopharmaceutical company, have been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) for their biologics license application...
The World Health Organization (WHO) has released a detailed plan that seeks $31.3 billion in funding to support the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration launched by the WHO and others to accelerate the development,...
Advanced Accelerator Applications (AAA), a Novartis company, has executed a sales and purchase agreement for a 50,000-square-foot piece of land in Indianapolis, Indiana to build a radioligand therapy manufacturing plant.
The facility will expand...
CSL Behring has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy for treating hemophilia B from uniQure, an Amsterdam-based gene-therapy company, in a deal worth up to $2 billion ($450...
The US Food and Drug Administration has issued final guidance that provides recommendations to pharmaceutical manufacturers on actions to take when an employee who has been directly involved in manufacturing drugs has a confirmed infection of...
Mylan reports that a US federal district court has invalidated a patent for Biogen's Tecfidera (dimethyl fumarate), a drug to treat relapsing multiple sclerosis (MS), which opens a path for Mylan to launch a generic version of the drug upon...
Bayer has agreed to pay between $10.1 billion and $10.9 billion to resolve current and future product-liability litigation in the US over its glyphosate-based herbicide, Roundup, which the company acquired in its $63-billion acquisition of the...
