Humanigen initiated submission for lenzilumab Marketing Authorization in COVID-19, to United Kingdomﾒs MHRA
On Jun. 14, 2021 Humanigen announced it had initiated a rolling review submission for Marketing Authorization (MA) by…
Merck announced supply agreement with U.S. Government for molnupiravir, an Investigational oral antiviral treatment of COVID-19
On Jun. 8, 2021, Merck announced it had entered into a procurement agreement with the U.S. government for…
RECOVERY trial found aspirin does not improve survival for patients hospitalised with COVID-19
On Jun. 8, 2021, the University of Oxford announced that the RECOVERY trial found aspirin does not improve…
Senolytics reduced COVID-19 symptoms in preclinical studies
On Jun. 8, 2021, Mayo Clinic researchers and colleagues at the University of Minnesota showed that COVID-19 exacerbates…
Innovation Pharma completed enrollment in phase 2 clinical trial for COVID-19
On Jun. 3, 2021, Innovation Pharma announced that it had achieved full patient enrollment in its randomized, double-blind,…
NIH clinical trial evaluating mixed COVID-19 vaccine schedules began
On Jun. 1, 2021, the National Institutes of Health announced that it had started a Phase 1/2 clinical…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved LUMAKRAS for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
On May 28, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved LUMAKRAS (sotorasib)…
Humanigen submitted application to FDA for Emergency Use Authorization for lenzilumab in COVID-19
On May 28, 2021, Humanigen announced that the company had submitted an application to the FDA requesting Emergency…
Novartis and Molecular Partners announced start of EMPATHY clinical trial for ensovibep for treatment of COVID-19
On May 27, 2021, Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase…
Patient enrollment reached 90 percent in Innovation Pharma’s phase 2 clinical trial of brilacidin for COVID-19
On May 27, 2021, Innovation Pharma announced that patient enrollment in the Company’s 120-patient, Phase 2 clinical trial…
Patient enrollment reached 90 percent in Innovation Pharmaceuticals phase 2 clinical trial of Brilacidin for COVID-19
On May 27, 2021, Innovation Pharmaceuticals announced that patient enrollment in the Companyﾒs 120-patient, Phase 2 clinical trial…
AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan
On May 21, 2021, AstraZeneca announced that it had been granted a special approval for emergency use in…
Brazilian HRA authorized Sorrento phase 2 pivotal clinical trial of COVI-MSCﾙ in hospitalized COVID-19 patients with ARDS
On May 20, 2021, Sorrento Therapeutics announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed…
APEIRON Biologics’ APN01 selected for large-scale U.S. trial in COVID-19
On May 19, 2021, APEIRON Biologics announced the next development steps for APN01 (alunacedase alfa) for the treatment…
Medicago and GSK announced positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate
On May 18, 2021, GlaxoSmithKline and Medicago reported positive interim Phase 2 clinical trial safety and immunogenicity data…
INOVIO announced positive data from phase 2 clinical trial evaluating INO-4800 COVID-19 DNA vaccine
On May 10, 2021, Inovio Pharma announced positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded…
NEJM published phase 2b clinical trial results demonstrating efficacy of COVID-19 vaccine against B.1.351 variant
On May 5, 2021, Novavax announced the publication of results from the initial primary analysis of a Phase…
Pfizer and BioNTech received Health Canada authorization of COVID-19 vaccine in adolescents
On May 5, 2021, Pfizer and BioNTech announced that Health Canada had expanded the Interim Order authorization for…
Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccine
On May 3, 2021, Novavax announced that it had initiated a pediatric expansion of its Phase 3 clinical…
Innovation Pharma surpassed 50 percent enrollment in phase 2 clinical trial of Brilacidin for COVID-19
On Apr. 28, 2021, Innovation Pharma announced that enrollment had surpassed 50 percent of the total targeted number…
NIH established new childhood asthma clinical research network
On Apr. 23, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announced that it had awarded…
Clinical trial of therapeutics for severely ill hospitalized COVID-19 patients began
On Apr. 22, 2021, the NIH announced that a phase 3 trial to test the safety and efficacy…
Valneva initiated pivotal phase 3 clinical trial for inactivated, COVID-19 vaccine using Dynavax’s CpG 1018ﾙ adjuvant
On Apr. 21, 2021, Dynavax Technologies announced Valneva had initiated a pivotal Phase 3 clinical trial for its…
Large clinical trial launched to study repurposed drugs to treat COVID-19 symptoms
On Apr. 19, 2021, the NIH announced that it was funding a large, randomized, placebo-controlled Phase 3 clinical…
Experimental antiviral for COVID-19 was effective in hamster study
On Apr. 15, 2021, the National Institutes of Health announced that the experimental antiviral drug MK-4482 significantly decreased…
Novavax announced participation in University of Oxford Com-COV2 study comparing mixed COVID-19 vaccine combinations
On Apr. 14, 2021, Novavax announced its participation in an expanded investigator-initiated Phase 2 clinical trial called Comparing…
NIAID trial of Anti-CD14 antibody to treat COVID-19 respiratory disease began
On Apr. 13, 2021, a clinical trial testing the safety and efficacy of an investigational monoclonal antibody for…
Positive topline data showed Fostamatinib met primary endpoint of safety in phase 2 clinical trial in hospitalized COVID-19 patients
On Apr. 13, 2021, Rigel Pharma announced the completion of patient enrollment in a multi-center Phase 2 clinical…
NIH began study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines
On Apr. 7, 2021, the National Institutes of Health (NIH) announced that a clinical trial was underway to…
Positive phase 1/2 results reported for Valneva’s inactivated COVID-19 vaccine candidate using CpG 1018ﾙ adjuvant
On Apr. 5, 2021, Dynavax Technologies announced that Valneva had reported positive initial results for Part A of…