The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
The latest contributions from Merck & Co., Allergan, Bayer, and Merck KGaA in funding and donations supporting relief efforts against COVID-19.
Merck & Co. Commits Additional $10 M to COVID-19 Relief Efforts Merck & Co. and the Merck...
A roundup of developments from the UK (AstraZeneca) and the US (Amgen, Fresenius Kabi).
UK
AstraZeneca Gains Global Rights to Allergan’s Autoimmune Disease DrugAstraZeneca has completed its previously communicated agreement with...
The latest developments on diagnostics and testing for COVID-19 featuring news from Thermo Fisher, Quidel, and Rutgers University.
FDA Provides First Emergency Use OK for COVID-19 Antigen TestLast week (May 9, 2020), the US Food and Drug...
The latest from pharma companies on potential COVID-19 treatments and vaccines with news from Moderna, Novavax, Gilead, Mylan, Lilly, Glenmark, and Sorrento.
News from Moderna, Novavax, Gilead Sciences, and Mylan
FDA Fast-Tracks Moderna’s...
Merck & Co. plans to consolidate its New Jersey campuses into a single New Jersey headquarters location in Rahway by the end of 2023. Additionally, the company announced Organon & Co. as the name of the pending spin-off of its women’s...
The US Food and Drug Commissioner Stephen Hahn provided an update on FDA surveillance inspections during the COVID-19 pandemic.
The FDA “will continue to utilize and implement additional alternative inspection tools and approaches while postponing...
AbbVie has completed its $63-billion acquisition of Allergan following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court (Allergan is headquartered in Dublin,...
Alexion Pharmaceuticals, a Boston-based biopharmaceutical company focused on rare diseases, has agreed to acquire Portola Pharmaceuticals, a South San Francisco-based commercial-stage biopharmaceutical company, for $1.4 billion.
Portola’s lead...
The latest from pharma companies on potential COVID-19 treatments and diagnostics with news from Roche, Amgen, Incyte, Lilly, Regeneron, CSL and others.
News from Roche, Amgen, Incyte, Regeneron, Lilly, and CSL
FDA OKs Emergency Use for Roche’s...
