Roche announced FDA approval of Xofluza for prevention of influenza following contact with infected person
On Nov. 24, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) had approved a supplemental…
Biotechnology | COVID-19 | Disease | Therapeutics | Vaccine
NeuroRx and Relief announced successful results from expanded use of RLF-100 in patients with COVID-19
On Nov. 24, 2020, RELIEF THERAPEUTICS announced that more than 175 patients with Critical COVID-19 and Respiratory Failure…
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…
AI detected COVID-19 on chest X-rays faster and with more accuracy than radiologists
On Nov. 24, 2020, Northwestern University researchers announced they had developed a new artificial intelligence (A.I.) platform that…
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…
Mayo Clinic research confirmed critical role of masks in preventing COVID-19 infection
On Nov. 24, 2020, published data from researchers at Mayo Clinic found that physical separation reduced the exposure…
Todos Medical completed installation of lab automation equipment at Wisconsin lab for COVID-19 PCR testing
On Nov. 24, 2020, Todos Medical announced that it has completed the installation of Tecan’ laboratory automated equipment…
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…
FDA expanded approval of influenza treatment to post-exposure prevention
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) expanded the approved indication for Genentech’s Xofluza…
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…
Disease | FDA | Rare Disease
FDA approved first drug to treat rare metabolic disorder
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’s Oxlumo (lumasiran) as the…
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…
CytoDyn reached enrollment target of 293 patients for 2nd DSMC interim analysis of phase 3 COVID-19 trial
On Nov. 23, 2020, CytoDyn announced it had reached enrollment of 293 patients in its Phase 3 trial…
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…
Avian influenza virus spread rapidly in Europe
On Nov. 20, 2020, the ‘European Food Safety Authority reported that within the past month more than 300…
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…
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…
Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
XBiotech data showed effective anti-virus activity for antibodies in candidate influenza-COVID-19 therapeutic
On Nov. 19, 2020, XBiotech announced data for its breakthrough candidate therapy for treating infections of influenza and…