Gilead announced long-acting HIV-1 capsid inhibitor, lenacapavir, achieved primary endpoint in phase 2/3 study
On Nov. 18, 2020, Gilead Sciences announced topline results from the Phase 2/3 CAPELLA trial evaluating the company’s…
OHSU study screened wastewater, test volunteers for coronavirus
On Nov. 18, 2020, Oregon Health & Science University (OHSU) announced an initiative that will attempt to discern…
Biotechnology | COVID-19 | FDA | Therapeutics
RedHill’s second COVID-19 candidate cleared by FDA for phase 2/3 Study in symptomatic COVID-19 disease
On Nov. 17, 2020, RedHill Biopharma announced that the U.S. Food and Drug Administration (FDA) had cleared the…
Mayo Clinic reported 900 employees contracted COVID-19 from local community
On Nov. 17, 2020, the Mayo Clinic reported that more than 900 employees had contracted COVID-19 in the…
Celdara Medical secured SBIR funding to develop an adjuvanted universal flu vaccine
On Nov. 17, 2020, Celdara Medical announced that the National Institute of Allergy and Infectious Disease (NIAID) of…
bioMerieux announced CE marking of ARGENE SARS-CoV-2 diagnostic test to include saliva specimens
On Nov. 16, 2020, bioMerieux announced the expansion of its ARGENE range for the detection of SARS-CoV-2. As…
RedHill completed enrollment for COVID-19 US phase 2 study with opaganib
On Nov. 16, 2020, RedHill Biopharma announced that the U.S. Phase 2 study with opaganib (Yeliva, ABC294640)1 in…
Wellcome Sanger Institute and COG-UK received £122M UK investment for COVID-19 genomic surveillance
On Nov. 16, 2020, the UK Department for Health and Social Care Testing Innovation Fund announced £12.2M funding…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Sorrento announced IND filing for COVI-DROPS against SARS-CoV-2
On Nov. 11, 2020, Sorrento Therapeutics announced that it was filing an investigational new drug application (IND) for…
DSMB analysis recommended continuance of P3 COVID-19 ARDS trial
On Nov. 11, 2020, Mesoblast announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with…
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…
Medigen Vaccines and BlueWillow Biologics partnered to Develop intranasal vaccine for SARS-COV-2
On Nov. 19, 2020, Medigen Vaccine Biologics and BlueWillow Biologics announced a partnership to develop S-2P-NE-01, a nasal…
Ultragenyx announced plans to build large-scale gene therapy manufacturing facility for rare diseases
On Nov. 9, 2020, Ultragenyx announced that it planned to build a new large-scale gene therapy manufacturing facility…