Pfizer and BioNTech submitted application for Conditional Marketing Authorization for COVID-19 vaccine
On Dec. 1, 2020, Pfizer and BioNTech announced they had submitted on Nov. 30, 2020, a formal Application…
VBI Vaccines announced submission of BLA to FDA for 3-antigen prophylactic Hepatitis B vaccine
On Dec. 1, 2020, VBI Vaccines announced the submission of a Biologics License Application (BLA) to the FDA…
Experimental vaccine for deadly tickborne virus effective in cynomolgus macaques
On Nov. 25, 2020, the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes…
Jaguar Health announced development of Crofelemer for inflammatory diarrhea, with ‘Long-Hauler’ COVID-19 patients
On Nov. 30, 2020, Jaguar Health subsidiary, Napo Pharmaceuticals, announced that Jaguar and Napo are planning to develop…
NIH announced restructured HIV clinical trials networks
On Nov. 30, 2020, The National Institute of Allergy and Infectious Diseases (NIAID) announced the clinical investigators and…
DARPA and JPEO awarded contract to SmartPharm for development of rapid COVID-19 countermeasure,
On Nov. 27, 2020, SmartPharm Therapeutics, a wholly-owned subsidiary of Sorrento Therapeutics, announced that it had been awarded…
NIAID announced fourth iteration of COVID-19 treatment trial was underway
On Nov. 25, 2020, the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes…
AIM ImmunoTech announced patient dosed in study of Ampligen as combo treatment for patients with cancer and COVID-19
On Nov. 25, 2020, AIM ImmunoTech announced that Roswell Park Comprehensive Cancer Centerﾒs Phase 1/2a study evaluating the…
Altimmune announced submission of Investigational NDA for AdCOVIDﾙ a single-dose intranasal COVID-19 vaccine
On Nov. 25, 2020, Altimmune announced that it had submitted an Investigational New Drug (IND) application to the…
BioNTech and Fosun Pharma announced start of phase 2 clinical trial of mRNA COVID-19 vaccine in China
On Nov. 25, 2020, BioNTech and Shanghai Fosun Pharmaceutica jointly announced that their lead mRNA COVID-19 vaccine candidate…
University of Saskatchewan research team sequenced the genomes for 15 wheat varieties
On Nov. 25, 2020, a University of Saskatchewan research team announced it had sequenced the genomes for 15…
Immune cells trained in the gut protect the brain
On Nov. 24, 2020, National Institutes of Health researchers reported they had found that the brainﾒs protective membranes…
Commonly used antibiotic showed promise for combating Zika infections
On Nov. 24, 2020, preclinical study by the National Institutes of Health (NIH) suggested FDA-approved tetracycline-based antibiotics may…
Less than 10% of people in the U.S. had detectable SARS-CoV-2 antibodies as of September 2020
On Nov. 24, 2020, JAMA reported that fewer than 10% of people in tye U.S. as of September…
MediciNova announced initiation of master virus seed stock production for intranasal COVID-19 vaccine
On Nov. 24, 2020, MediciNova announced development progress on its intranasal SARS-CoV-2 vaccine for COVID-19 utilizing BC-PIV, a…
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…
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…
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…