Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Futura, Genentech, Mustang, Precigen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ascendis, BMS, Idorsia, Incyte, Karyopharm, Novartis, Xeris.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) commitment of up to $483 million to accelerate Moderna Inc.’s mRNA vaccine candidate, mRNA-1273, in efforts to fight coronavirus (SARS-CoV-2) would enable the company to supply millions of doses per month in 2020 and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.
LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data are available, expected in August or September.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chi-Med, Everest, Redhill, Seattle Genetics.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clarus Therapeutics, Cynata Therapeutics, Evolus, Halix, Highlight Therapeutics, Lipocine, Nicox, Ocumension Therapeutics, Redhill Biopharma, Retrotope, Roche, Storm Therapeutics.
RSS
