Biological E Limited started phase I/II clinical trial of its COVID-19 vaccine candidate
On Nov. 16, 2020, Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies, and Baylor…
Moderna announced longer shelf life for its COVID-19 vaccine candidate at refrigerated temperatures
On Nov. 16, 2020, Moderna announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remained stable at…
Innovation Pharma announced overseas regulatory filing submitted for COVID-19 clinical study
On Nov. 16, 2020, Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) has been submitted to…
Tonix Pharmaceuticals reported positive immune response results from COVID-19 Vaccine candidate
On Nov. 16, 2020, Tonix Pharmaceuticals announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox…
BioNTech and Fosun Pharma approved to commence COVID-19 vaccine candidate BNT162b2 trial in China
On Nov. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutica announced that the China National Medical Products Administration had…
INOVIO announced initiation of phase 2/3 clinical trial for COVID-19 DNA vaccine candidate, INO-4800
On Nov. 16, 2020, INOVIO announced that it had received clearance from the the U.S. Food & Drug…
Aegis Sciences launched combined test for SARS-CoV-2 and influenza A/B virus
On Nov. 16, 2020, Aegis Sciences announced that it had launched a combined test for SARS-CoV-2 and influenza…
European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
Johnson & Johnson Initiated second global phase 3 clinical trial of Janssen COVID-19 vaccine candidate
On Nov. 15, 2020, Johnson & Johnson announced that it continued to enroll and vaccinate study participants for…
Moderna’s COVID-19 vaccine candidate met primary endpoint in first interim analysis of phase 3 COVE study
On Nov. 15, 2020, an independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of…
COVID-19 patients treated with fluvoxamine had lower likelihood of clinical deterioration over 15 days
On Nov. 14, 2020, JAMA reported that in a preliminary study, adult outpatients with symptomatic COVID-19 treated with…
CHMP recommended EU approval of Roche’s Xofluza (baloxavir marboxil) for the treatment of influenza
On Nov. 13, 2020, Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
Biotechnology | Chemical | FDA | Therapeutics
FDA approved Merck’s KEYTRUDA (pembrolizumab) in combination with chemo for patients with TNBC
On Nov. 13, 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, Merck’s…
Cardiac arrest treatment that uses life support machine boosted survival
On Nov. 13, 2020, the NIIH announced that using a life support machine to replicate the functions of…
Biotechnology | COVID-19 | FDA | Therapeutics
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure
On Nov. 13, 2020, NeuroRx and Relief Therapeutics announced that to-date, 150 patients (out of a targeted enrollment…
Biotechnology | FDA | Oncology | Therapeutics
Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer
On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for…
Swissmedic began rolling review of Moderna’s mRNA vaccine against COVID-19
On Nov. 13, 2020, Moderna announced that Swissmedic had started a rolling review of mRNA-1273, the Company’s vaccine…
Respiratory failure in COVID-19 usually not driven by cytokine storm
On Nov. 13, 2020, a study from Washington University School of Medicine in St. Louis and St. Jude…
Albert Einstein College of Medicine received $5 million NIH grant to study HIV and HPV cancers in Africa
On Nov. 13, 2020, Albert Einstein College of Medicine announced that it had received a five-year, $4.9 million…
CALAVI did not meet the primary endpoint in patients hospitalised with respiratory symptoms of COVID-19
On Nov. 12, 2020, AstraZeneca announced that the CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised…
CureVac’s COVID-19 vaccine candidate, CVnCoV, suitable for standard fridge temperature logistics
On Nov. 12, 2020, CureVac announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined…
Gates Foundation announced funds to develop COVID-19 vaccines and increase access in low-income countries
On Nov. 12, 2020, the Bill & Melinda Gates Foundation announced new commitments totaling $70 million to global…
Vaxart announced additional data from Hamster Challenge Study of its oral COVID-19 vaccine
On Nov. 12, 2020 Vaxart announced additional results from its Hamster Challenge Study. The study evaluated Vaxartﾒs recombinant…
CIRM Board approved four new clinical trials
On Nov.12, 2020, the governing Board of the California Institute for Regenerative Medicine (CIRM) approved four new clinical…
Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
Early mutation in SARS-CoV-2 virus in Europe led to its domination world wide
On Nov. 12, 2020, a study published in Science by a team of researchers in the U.S. and…
Treatments for people with early COVID-19 infection urgent research focus
On Nov. 11, 2020, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D., and…
COVISHIELD completed enrollment of phase III clinical trials under partnership of ICMR and Serum Institute
On Nov. 11, 2020, the Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) announced…
Mateon and Windlas Biotech announced agreement to commercialize ARTIVEDA against COVID-19
On Nov. 11, 2020, Mateon Therapeutics announced an agreement with Windlas Biotech of India to commercialize ARTIVeda. ARTIVeda…
Moderna completed case accrual for first planned interim analysis of mRNA vaccine against COVID-19
On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of…