The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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Novartis has voluntarily withdrawn its marketing authorization application (MAA) in the European Union for Xiidra (lifitegrast ophthalmic solution), a prescription drug for treating dry eye.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...
Merck & Co. has completed its previously announced acquisition of Themis Bioscience, a Vienna, Austria-based biopharmaceutical company developing vaccines and immune-modulation therapies for infectious diseases and cancer.
With the completion...
Bristol-Myers Squibb has sold a former 1.2-million-square-foot life-sciences campus in the Princeton, New Jersey area to the real-estate firms, Lincoln Equities Group and H.I.G. Realty Partners. The 433-acre campus is located seven miles from...
Gilead Sciences has agreed to acquire a 49.9% equity interest in Pionyr Immunotherapeutics, a South San Francisco, California-based biopharmaceutical company developing cancer immunotherapies, in a deal worth up to $1.74 billion.
Pionyr has two...
Sanofi Pasteur, the vaccines business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for...
The latest on manufacturing and potential treatments for COVID-19 with news from Novartis, the National Institutes of Health, Gilead, GSK, Congress, Inovio, and Cipla.
News from Novartis, NIH, Gilead, GSK, Congress
Novartis Discontinues Trial of...
AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), led by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by...
