The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Health experts, researchers, and major funders met at the World Health Organization headquarters in Geneva this week (week of February 10, 2020) to prioritize research and funding to address the coronavirus outbreak.
They met to assess the current...
Johnson & Johnson’s Janssen reports it will further expedite its investigational coronavirus (COVID-19) vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the...
A roundup of developments from Australia (CSL), Germany (Bayer), India (Lupin, Wockhardt), and the US (GE).
Australia
CSL Partners with University of Queensland to Develop Coronavirus Vaccine
CSL, a biotechnology company for vaccines and...
The US Food and Drug Administration (FDA) has issued six final guidances relating to manufacturing and clinical development of gene therapies and a draft guidance relating to gene therapies and orphan-drug designation.
The six final guidances...
Novo Nordisk plans to invest DKK 800 million ($117 million) to upgrade and expand facilities at its production site in Kalundborg, Denmark, which currently manufacture a range of products for diabetes treatment.
The facilities will be rebuilt and...
Bristol-Myers Squibb (BMS) and BioMotiv, a drug-development accelerator company that is focused on early-stage drug development, have launched Anteros Pharmaceuticals, a biopharmaceutical company focused on developing drugs for fibrotic and other...
AstraZeneca plans to invest $200 million in its manufacturing facility in North Ryde, Sydney, Australia to increase the facility’s production capabilities for respiratory medicines to treat asthma and chronic obstructive pulmonary disease.
The...
GlaxoSmithKline (GSK) and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, agreed to collaborate on developing a vaccine for...
The World Health Organization (WHO) reports that $675 million is needed for a coronavirus global preparedness and response plan and the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provided updates to the actions...
A roundup of developments from Dominican Republic and Germany, (Fresenius Kabi), India (Aurobindo), and the US (FDA).
Dominican Republic
Fresenius Kabi Expands Apheresis Sets Production Site in Dominican Republic
Fresenius Kabi, a Bad Homburg,...
Merck & Co. plans to spin off products from its Women’s Health, Legacy Brands, and Biosimilars businesses to form a new, yet-to-be-named, independent, publicly traded company (NewCo) while retaining higher growth products in Merck. The spinoff...
Sandoz, the generics and biosimilars arm of Novartis, has completed its acquisition of the Japanese business of Aspen Global Inc. (AGI), a wholly owned subsidiary of the specialty and branded pharmaceutical company, Aspen Pharmacare, in a deal...
As part of an investigation of potential nitrosamine impurities in metformin, the active pharmaceutical ingredient (API) in diabetes medications, the US Food and Drug Administration (FDA) reported that the levels of nitrosodimethylamine (NDMA), a...
The US Food and Drug Administration (FDA) has outlined its actions to advance development of coronavirus (2019-nCoV) medical countermeasures for the outbreak in Wuhan, China. This includes collaboration with interagency partners, product...
Johnson & Johnson (J&J) has announced that it is launching a multi-pronged response to the coronavirus (2019-nCoV or Wuhan coronavirus) outbreak, which includes initiating development of a vaccine candidate against 2019-nCoV and broadly...
