RedHill Biopharma expanded U.S.-based manufacturing capacity of opaganib for COVID-19
On Nov. 25, 2020, RedHill Biopharma announced partnerships with two leading, U.S.-based manufacturers for large-scale manufacturing of opaganib….
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…
Moderna announced EC approval of purchase agreement for 80 million doses of mRNA COVID-19 vaccine
On Nov. 25, 2020, Moderna announced that the European Commission (EC) has approved an agreement to secure 80…
BioNTech and InstaDeep announce AI Innovation Lab to develop novel immunotherapies
On Nov. 25, 2020, BioNTech and InstaDeep announced a multi-year strategic collaboration aimed at applying the latest advances…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…