Roche received FDA Emergency Use Authorization for new test to measure level of SARS-CoV-2 antibodies
On Dec. 2, 2020, Roche announced that its Elecsysﾮ Anti-SARS-CoV-2 S antibody test had received Emergency Use Authorization…
UK medicines regulator approved first UK COVID-19 vaccine
On Dec. 2, 2020, the first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, was given approval for…
Codex DNA released new synthetic genomes for the fight against COVID-19
On Dec. 2, 2020, Codex DNA announced the release of seven new synthetic SARS-CoV-2 genomes for use in…
Lilly announced 650,000 additional doses of COVID-19 neutralizing antibody bamlanivimab purchased by US government
On Dec. 2, 2020, Eli Lilly announced that the U.S. government had purchased 650,000 additional doses of the…
Pfizer and BioNTech achieved first authorization in the world for a vaccine to combat COVID-19
On Dec. 2, 2020, Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in…
FDA approved first PSMA-targeted PET imaging drug for men with prostate cancer
On Dec. 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) ﾖ the first drug for…
US Department of Defense awarded $50 million in university research equipment award
On Dec. 1, 2020, the U.S. Department of Defense announced awards to 150 university researchers totaling $50 million…
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…
FDA approved first drug to treat rare metabolic disorder
On Nov. 23, 2020, the FDA approved Alnylam Pharmaceuticals’s Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria…
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…