Baxter announced $50 million investment to expand sterile fill/finish manufacturing site in Bloomington, Ind
On Nov. 24, 2020, Baxter announced a $50 million expansion of its sterile fill/finish manufacturing facilities located in…
Oxford University reported breakthrough on global COVID-19 vaccine
On Nov. 23, 2020, the University of Oxford, in collaboration with AstraZeneca, announced interim trial data from its…
AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
On Nov. 23, 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of AZD1222…
Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adults
On Nov. 23, 2020, Merck, known as MSD outside the U.S. and Canada, announced the company had submitted…
Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric…
Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseﾮ for COVID-19
On Nov. 23, 2020, Bellerophon Therapeutics announced that the independent Data Monitoring Committee (DMC) had completed its pre-specified…
National Resilience launched as the worldﾒs most advanced biopharmaceutical manufacturing ecosystem
On Nov. 23, 2020, National Resilience, founded by ARCH Venture Partnersﾒ Robert Nelsen, launched as the worldﾒs most…
FDA authorized monoclonal antibodies for treatment of COVID-19
On Nov. 21, 2020, the FDA issued an emergency use authorization (EUA) for Regeneron Pharmaceuticals’ casirivimab and imdevimab…
Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
On Nov. 21, 2020, Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together (also known as…
Aptima HIV-1 Quant Dx assay receivds additional FDA approval for use as aAid in diagnosis of HIV infection
On Nov. 30, 2020, Hologic announced that the FDA had approved a diagnostic claim for its HIV-1 (human…
Broad Institute rapid COVID-19 test delivered accurate results with minimal equipment
On Nov. 20, 2020, researchers at the Broad Institute of MIT and Harvard announced they had developed a…
Pfizer and BioNTech to submit Emergency Use Authorization Request to the FDA for COVID-19 vaccine
On Nov. 20, 2020, Pfizer and BioNTech announced they submitted a request to the Food and Drug Administration…
NIH expanded research to improve COVID-19 testing among underserved and vulnerable populations
On Nov. 20, 2020, the National Institutes of Health (NIH) awarded nearly $45 million to expand the research…
Prior COVID-19 infection offered protection from re-infection for at least six months
On Nov. 20, 2020, the University of Oxford announced a study suggested that individuals who have previously had…
Eiger announced FDA approval of Zokinvyﾙ (lonafarnib) treatment for Hutchinson-Gilford Progeria Syndrome
On Nov. 20, 2020, Eiger BioPharmaceuticals announced that the FDA had approved ZokinvyTM (lonafarnib) for the treatment of…
Lilly’s neutralizing antibody bamlanivimab received interim authorization from Health Canada as treatment for COVID-19
On Nov. 20, 2020, Eli Lilly announced that Health Canada had granted authorization under the Interim Order Respecting…
FX06 clinical trial for treatment of most severely affected patients with COVID-19 begun in France
On Nov. 19, 2020, F4 Pharma announced the inclusion of the first patient with severe COVID-19 in a…
Oxford Coronavirus vaccine produced strong immune response in older adults
On Nov. 19, 2020, the University of Oxford announced that the ChAdOx1 nCov-2019 coronavirus vaccine had been shown…
ApiJect approved for $590 million loan from US International DFC to build drug manufacturing facility in North Carolina
On Nov. 19, 2020, ApiJect Systems, a public benefit corporatio, announced that it had been approved by the…
BioVersys announced first subjects dosed in phase 1 clinical trial of BV100
On Nov. 18, 2020, BioVersys announced a milestone by entering clinical development with the start of Phase 1…
Relief Therapeutics selected CRO and CDMO for RLF-100TM in Europe
On Nov. 18, 2020, RELIEF THERAPEUTICS announced the appointment of Syneos Healthﾮ, a leading global clinical research organization…
Pfizer and BioNTech announced phase 3 study of COVID-19 vaccine candidate met all efficacy endpoints
On Nov. 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing…
Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
The US Dept of Veterans Affairs, federal partners plan for COVID-19 vaccination distribution
On Nov. 17, 2020, the U.S. Dept. of Veterans Affairs (VA) announced it was working with the Centers…
CureVac established European-based network for manufacturing of COVID-19 vaccine candidate, CVnCoV
On Nov. 17, 2020, CureVac announced that it had accelerated the expansion of its manufacturing network to deliver…
FDA authorized first COVID-19 test for self-testing at home
On Nov. 17, 2020, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test…
Overweight and obese younger people at greater risk for severe COVID-19
On Nov. 17, 2020, UT Southwestern researchers reported that being younger doesnﾒt protect against the dangers of COVID-19…
NIH to fund research of racial disparities in pregnancy-related complications and deaths
On Nov. 17, 2020, the NIH announced funding of new research examining racial and ethnic disparities in pregnancy-related…
European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
Bausch Health announced investigational in vitro data indicating inactivation of SARS-CoV-2 with eye drops
On Nov. 16, 2020, Bausch Health announced the results of new investigational in vitro data showing that two…