BioNTech, Fosun Pharma Vaccinate Patients in New Phase 1 Chinese Study August 6, 2020 BioNTech is supplying the vaccine for the China trial from its manufacturing facilities in Europe. Read More
Yourgene’s SARS-CoV-2 Test Obtains CE Mark August 5, 2020 The diagnostic kit also includes an internal control to identify when samples are of poor quality and may give invalid results. Read More
FDA Retires MedWatch to Manufacturers Program August 5, 2020 The agency said FAERS provides manufacturers the same information within the same time frame or more quickly. Read More
Clinical Reference Laboratory Gets EUA for COVID-19 Saliva Test August 4, 2020 CRL is aiming to process more than 50,000 tests a day. Read More
Wockhardt to Provide COVID-19 Vaccine Manufacturing to the UK August 4, 2020 The company will begin production next month at its facility in North Wales. Read More
Pfizer, BioNTech to Supply Japan With 120 Million Doses of COVID-19 Vaccine August 3, 2020 Pfizer and BioNTech began a phase 2/3 trial of their lead COVID-19 vaccine candidate on July 27. Read More
PharmaCyte’s Licensed SARS-CoV-2 Tests Earn CE Mark July 31, 2020 The company will seek FDA authorization for a pool testing protocol that would allow multiple samples to be analyzed together. Read More
RedHill Biopharma Starts Global Trial of Yeliva for COVID-19 July 31, 2020 Participants will receive Yeliva or a placebo along with the standard-of-care. Read More
Caption Health’s AI Software Cleared July 30, 2020 The software offers “comparable performance to an expert quantitative measurement,” the company said. Read More
Sanofi and GSK to Supply UK 60 Million Doses of COVID-19 Vaccine July 30, 2020 Sanofi plans to begin a phase 1/2 trial of the vaccine in September, followed by a phase 3 study by the end of the year. Read More
Bruker Earns CE Mark for PCR COVID-19 Test July 29, 2020 The test demonstrated 100 percent accuracy in two clinical trials. Read More
HHS Reserves COVID-19 Vaccine Manufacturing Capacity at Fujifilm’s Texas Facility July 29, 2020 The contract will accelerate an expansion at the facility for completion by fall 2020. Read More