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 issued final guidance in the form of a question-and-answer guide to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the...
Akorn, a specialty generic pharmaceutical company, and its US subsidiaries have filed for voluntary protection under Chapter 11 of the US Bankruptcy Code to execute an in-court sale of its business.
In connection with the filing made in the US...
Gilead Sciences and Arcus Biosciences, a Hayward, California clinical-stage company focused on cancer immunotherapies, have entered into a 10-year partnership, worth up to $2 billion, to co-develop and co-commercialize current and future...
The latest on manufacturing and potential treatments for COVID-19 with news from GSK, Roche, Merck & Co., Gilead, WHO, and Amarin.
GSK To Produce 1 Billion Doses of COVID-19 Vaccine Adjuvant GlaxoSmithKline (GSK) has announced its intention to...
The Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization providing vaccine development and advanced manufacturing capability to the UK, has been awarded £131 million ($161 million) by the UK government to create a...
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has acquired Praha Vaccines, part of the Cyrus Poonawalla Group, a Pune, Maharashtra, India-based business group, for approximately $167 million to expand manufacturing...
Merck & Co. has made two moves to advance vaccine candidates against COVID-19: an announced acquisition of Themis Bioscience, a Vienna, Austria-based clinical-stage biopharmaceutical company that is developing a COVID-19 vaccine, and a...
The latest on potential COVID-19 treatments, vaccines, and diagnostics with news from GSK, Apple, Google, Fujifilm, Inovio, and CanSino Biologics, and Covis Pharma.
News from GSK, Apple, Google and Fujifilm
GSK, Mammoth Biosciences To Develop...
AstraZeneca has been awarded more than $1 billion from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services,...
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, and which is developing a mRNA vaccine candidate against the novel coronavirus, announced a public offering of 17,600,000 shares of...
The International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership, convened a virtual meeting...
The European Medicines Agency (EMA) is waiving fees for on-site GMP inspections of drug makers and blood establishments that have undergone remote inspections during COVID-19.
Plasma Master Files inspections are also in the scope of this...
A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), featuring NME approvals from Novartis, Eli Lilly and Company, Seattle Genetics, Incyte,...
The US Food and Drug Administration has issued guidance documents to help accelerate the development of prevention and treatment options for COVID-19. The FDA says the guidances make the process for submitting applications to initiate studies for...
Bristol Myers Squibb (BMS) and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have received a Refusal to File Letter from the US Food and Drug Administration (FDA) regarding the biologics license...
