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…
-
-
EMA accepted Pfizerﾒ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…
-
UTSW researchers identified mechanism by which exercise strengthens bones and immunity
On Feb. 25, 2021, scientists at the Childrenﾒs Medical Center Research Institute at UT Southwestern announced they had…
-
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…
-
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…
-
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…
-
Biotechnology | Disease | FDA | Genomics | Therapeutics
FDA approved targeted treatment for rare Duchenne muscular dystrophy mutation
On Feb. 25, 2021, the U.S. Food and Drug Administration (FDA) granted approval to Sarepta Therapeutics for Amondys…
-
IDMC found clear efficacy for REGEN-COVﾙ in phase 3 COVID-19 outpatient outcomes trial
On Feb. 25, 2021, Regeneron announced changes to the phase 3 trial assessing investigational REGEN-COVﾙ (casirivimab with imdevimab)…
-
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…
-
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…
-
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…
-
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…
-
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…
-
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 PerkinElmerﾮ COVID-19 Antigen Test for the qualitative detection…
-
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,…
-
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…
-
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 announced it had completed enrollment of PREVENT-19, its pivotal Phase 3 study in…
-
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…
-
First identification of human cases of avian influenza A(H5N8) infection
On Feb. 20, 2021, Russian authorities reported the detection of influenza A(H5N8) virus infection in seven poultry workers…
-
G7 leaders committed US$ 4.3 billion to finance global equitable access to tests, treatments and vaccines
On Feb. 19, 2021, the ACT Accelerator partnership welcomed over US$ 4.3 billion of new investments from the…
-
Johnson & Johnson announces submission to WHO for EUL of investigational single-shot COVID-19 vaccine candidate
On Feb. 19, 2021, Johnson & Johnson announced that Janssen-Cilag had submitted for Emergency Use Listing (EUL) to…
-
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine
Pfizer and BioNTech submited COVID-19 vaccine stability data at standard freezer temperature to the FDA
On Feb. 19, 2021, BioNTech announced the submission of new data to the FDA demonstrating the stability of…
-
Luminex received BARDA funding to support development and validation of test combining SARS-CoV-2 and Flu/RSV respiratory pane
On Feb. 19, 2021, Luminex announced that it had received $11.3 million in funding from the Biomedical Advanced…
-
Agilent announced immunoassay kit to detect SARS-CoV-2 antibodies
On Feb. 18, 2021, Agilent Technologies announced the launch of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay…
-
Plans underway for pediatric COVID-19 vaccine trials
On Feb. 18, 2021, Washington University pediatric infectious diseases doctors announced plans to launch clinical trials in the…
