CDC Advisory Committee recommended single-shot COVID-19 vaccine for adults 18 and older in US
On Feb. 28, 2021, Johnson & Johnson announced that the U.S. Centers for Disease Control and Preventionï¾’s (CDC)…
Johnson & Johnson single-shot COVID-19 vaccine authorized by US FDA for Emergency Use
On Feb. 27, 2021, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) had issued…
Roche SARS-CoV-2 rapid rntigen test received special approval for at-home patient self-testing in Germany
On Feb. 26, 2021, Roche announced it had been granted special approval by the German Federal Institute for…
Innovation Pharma provided study details for phase 2 clinical trial of Brilacidin in hospitalized COVID-19 patients
On Feb. 26, 2021, Innovation Pharmaceuticals announced that after an interim review, by an independent Data Monitoring Committee…
Novavax and Takeda finalize license agreement for Novavaxï¾’ COVID-19 vaccine candidate in Japan
On Feb. 26, 2021, Novavax and Takeda Pharmaceutical announced an exclusive license agreement for Takedaï¾’s development, manufacturing and…
Johnson & Johnson COVID-19 vaccine candidate recommended for EUA by FDA advisory committee
On Feb. 26, 2021, Johnson & Johnson announced that the FDA Vaccines and Related Biological Products Advisory Committee…
EMA accepted Pfizerï¾’s MAA for investigational 20-valent pneumococcal conjugate vaccine
On Feb. 26, 2021, Pfizer announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization…
EMA issued advice on Regeneron’s antibody cocktail (casirivimab with imdevimab) for COVID-19 patients
On Feb. 26, 2021, Regeneron announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use…
Biotechnology | Disease | FDA | Genomics | Life Science News | Therapeutics
FDA approved targeted treatment for rare Duchenne muscular dystrophy mutation
On Feb. 25, 2021, the FDA granted approval to Sarepta Therapeutics for Amondys 45 (casimersen) injection for the…
FDA allowed more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine
On Feb. 25, 2021, the U.S. Food and Drug Administration announced that it was allowing undiluted frozen vials…
Altimmune commenced enrollment in phase 1 trial of AdCOVID needle-free, single-dose Intranasal COVID-19 vaccine candidate
On Feb. 25, 2021, Altimmune announced that it had commenced enrollment in a Phase 1 clinical trial of…
Chimerix reported promising topline results from first cohort of a randomized COVID-19 trial with DSTAT
On Feb. 25, 2021, Chimerix reported topline results from the first cohort of its randomized, double-blind, placebo-controlled Phase…
Pfizer and BioNTech initiated sudy to evaluate COVID-19 booster and new vaccine variants
On Feb. 25, 2021, Pfizer and BioNTech announced they had begun an evaluation of the safety and immunogenicity…
IDMC found clear efficacy for REGEN-COVï¾™ in phase 3 COVID-19 outpatient outcomes trial
On Feb. 25, 2021, Regeneron announced changes to the phase 3 trial assessing investigational REGEN-COVï¾™ (casirivimab with imdevimab)…
UTSW researchers identified mechanism by which exercise strengthens bones and immunity
On Feb. 25, 2021, scientists at the Childrenï¾’s Medical Center Research Institute at UT Southwestern announced they had…
Overall deaths did not increase for most Chinese regions during the initial COVID-19 outbreak
On Feb. 24, 2021, scientists at the University of Oxford reported that overall deaths did not increase in…
COVID-19 vaccine doses shipped by the COVAX Facility head to Ghana, marked beginning of global rollout
On Feb. 24, 2021, Ghana became the first country outside India to receive COVID-19 vaccine doses shipped via…
XPhyto placed first order for 25-minute COVID-19 RT-PCR tests
On Feb. 24, 2021, XPhyto announced that it has placed the first order for its rapid point-of-care SARS-CoV-2…
NeuroRx announced that ZYESAMI (Aviptadil) had successfully demonstrated accelerated recovery from Covid-19 respiratory failure
On Feb. 24, 2021, NeuroRx, announced that the phase 2b/3 trial of ZYESAMI for the treatment of Respiratory…
Quest Diagnostics introduced new COVID-19 semi-quantitative serology test service
On Feb. 24, 2021, Quest Diagnostics introduced a new COVID-19 testing service that aids in providing insight into…
Monoclonal antibodies against MERS Coronavirus showed promise in phase 1 NIH-sponsored trial
On Feb. 23, 2021, the NIH announced that a randomized, placebo-controlled Phase 1 clinical trial of two monoclonal…
Cue received CE Mark for Its molecular point-of-care COVID-19 test
On Feb. 23, 2021, Cue Health announced that its molecular point-of-care COVID-19 Test had received the CE mark,…
Study demonstrated macrolide-resistance in S pneumoniae in the US exceeded 25 percent threshold set in CABP guidelines
On Feb. 23, 2021, Nabriva Therapeutics announced publication of a study documenting the high rates of macrolide-resistant Streptococcus…
PerkinElmer changed COVID-19 rapid testing with highly sensitive point of care antigen test for mass screening
On Feb. 23, 2021, PerkinElmer announced the launch of the PerkinElmerï¾® COVID-19 Antigen Test for the qualitative detection…
No-fault compensation programme for COVID-19 vaccines was a world first
On Feb. 22, 2021, the World Health Organization (WHO) and Chubb signed an agreement on behalf of the…
Amyris announced positive pre-clinical results for COVID-19 RNA vaccine platform
On Feb. 22, 2021, Amyris announced highly promising preliminary data in a pre-clinical study of its ribonucleic acid…
Adamis Pharma sleared to proceed with human studies of Tempol for the treatment of COVID-19
On Feb. 22, 2021, Adamis Pharma announced that the FDA had completed the safety review of the Companyï¾’s…
Biohaven’s multimodal antibody therapy demonstrated effective neutralization of multiple strains of COVID-19
On Feb. 22, 2021, Biohaven Pharmaceutical announced that a hyperimmune globulin mimic (HGM) developed with Biohaven’s proprietary MATE…
Novavax completed enrollment of PREVENT-19, COVID-19 vaccine pivotal phase 3 trial in the US and Mexico
On Feb. 22, 2021, Novavax and the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the…
BD announced collaboration for at-home rapid test for COVID-19
On Feb. 22, 2021, BD (Becton, Dickinson) and Scanwell Health, a leader in smartphone-enabled at-home medical tests, announced…