Long-acting injectable form of HIV prevention outperformed daily pill in NIH study
On Jul. 7, 2020, a pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form of the HIV drug…
The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…
National UK study investigated long-term health impacts of COVID-19
On Jul. 7, 2020, a major UK research study – PHOSP-COVID, will investigate the long-term health impacts of…
The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…
Immune Regulation partnered with DynPort Vaccine to advance drug product for COVID-19 into clinical trials
On Jul. 9, 2020, Altimmune announced that it had entered into a teaming agreement with DynPort Vaccine Company…
Emergent BioSolutions signed five-year agreement for large-scale drug substance manufacturing for Johnson & Johnsonﾒs COVID-19 vaccine candidate
On Jul. 6, 2020, Emergent BioSolutions announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, a Johnson &…
AIM ImmunoTech signed material transfer and research agreement with Japan’s National Institute of Infectious Diseases and Shionogi & Co to test Ampligen as potential vaccine adjuvant for COVID-19
On Jul. 6, 2020, AIM ImmunoTech announced that it had signed a material transfer and research agreement with…
ADMA Biologics opened its newest ADMA BioCenters plasma collection facility
On Jul. 6, 2020, ADMA Biologics announced the commencement of operations and initiation of collections at its newest…
Regeneron announced start of REGN-COV2 phase 3 COVID-19 prevention trial in collaboration with National Institute of Allergy and Infectious Diseases
On Jul. 6, 2020, Regeneron announced initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron’s investigational double antibody cocktail…
Mylan secured regulatory approval for remdesivir lyophilized powder for injection 100 mg/vial in India for restricted emergency use in COVID-19 patients
On Jul. 6, 2020, Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir…
Merck announced analyses showing additional safety and efficacy data for investigational Islatravir in combination with Doravirine in adults with HIV-1 infection
On Jul. 6, 2020, Merck announced a new analyses from the Phase 2b trial evaluating the safety and…
The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19
On Jul. 6, 2020, the FDA issued an emergency use authorization (EUA) for the third diagnostic test for…
Ignoring airborne COVID spread risky
On Jul. 6, 2020, the lack of universal recognition that COVID-19 is transmitted via airborne particles, along with…
Sinovac COVID-19 vaccine collaboration with Butantan received approval from Brazilian regulator for phase III trial
On Jul. 6, 2020, Sinovac Biotech announced that on Jul. 3, 2020, the Brazilian National Regulatory Agency, Anvisa,…
EC granted conditional Marketing Authorization for Gileadﾒs Vekluryﾮ (remdesivir) for treatment of COVID-19
On Jul. 3, 2020, Gilead Sciences announced the European Commission had granted conditional marketing authorization for Vekluryﾮ (remdesivir)…
Abivax treated first patient in phase 2b/3 ABX464 Covid-19 clinical trial
On Jul. 2, 2020, Abivax announced that the first patient has been treated in its Phase 2b/3 study…
TGen teamed with Poba Medical to produce 10,000 COVID-19 test kits per month
On Jul. 2, 2020, in response to the continuing need for more COVID-19 diagnostic tests, the Translational Genomics…
Maxim Biomedical rapid antigen COVID-19 test to deliver results in less than 15 minutes
On Jul. 2, 2020, Maxim Biomedical announced plans to produce and market as many as 3 million Maxim…
ViiV Healthcare announced FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults
On Jul. 2, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the FDA had…
NIH ACTIV vaccine working group weighed role of human challenge studies for SARS-CoV-2 vaccine development
On Jul. 1, 2020, in a Perspective for the New England Journal of Medicine, members of the NIHﾒs…
MediciNova announced IND for MN-166 (ibudilast) for prevention of ARD Syndrome in patients with COVID-19
On Jul. 1, 2020, MediciNova announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention…
Merck and Ridgeback Bio announced closing of collaboration and licensing transaction
On Jul. 1, 2020, Merck and and and Ridgeback Biotherapeutics announced that the U.S. Federal Trade Commission (FTC)…
T2 Biosystems announces US launch of COVID-19 diagnostic test
On Jul. 1, 2020, T2 Biosystems announced completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2…
OPKO Health’s BioReference Laboratories reports results of COVID-19 testing for almost one quarter of a million nursing home employees
On Jul. 1, 2020, OPKO Health announced the results of COVID-19 molecular PCR and antibody tests for nursing…
Pfizer and BioNTech announced early positive data from ongoing phase 1/2 study of mRNA-based vaccine candidate against SARS-CoV-2
On Jul. 1, 2020, Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine…
UC Berkeley launched trial of saliva test for COVID-19
On Jun. 30, 2020, scientists from the Innovative Genomics Institute (IGI) at the University of California Berkeley announced…
Gilead Sciences announced Covid-19 drug Remdesivir to cost $3,120 for typical patient on private insurance
On Jun. 29, 2020, Gilead Sciences announced that the Covid-19 drug Remdesivir will cost $3,120 for typical patient…
Oxford University dashboard highlighted potential future COVID-19 virus hotspots
On Jun. 29, 2020, the University of Oxford reported that potential COVID-19 hotspots can be identified using a…
Association between statewide school closure and COVID-19 incidence and mortality in the US
On Jun. 29, 2020, JAMA reported that U.S. populationﾖbased time series analysis conducted between March 9, 2020, and…
Altimmune received award from US DoD to fund phase 1/2 clinical trial of T-COVIDﾙ in outpatients with early COVID-19
On Jun. 29, 2020, Altimmune announced it was awarded $4.7 million from the U.S. Army Medical Research &…