The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Albireo, Amryt, Bebig, Beigene, Citius, Chugai, Lipocine, Pfizer, Rafarma, Sinovac, Sorrento, Tricida, Tvax, United, Valeo.
TORONTO – Ontario and British Columbia med-tech companies have received CA$1.4 million (US$1 million) from Ottawa’s Supercluster fund, making a difference they said for patients suffering the long-range effects of COVID-19, chronic disease and undergoing joint replacement surgery.
No one will be sad to see the back of a horrendous year, with the raging pandemic bringing the world to its knees. However, the potential end to this dire situation is now tantalizingly in sight. The collective sigh of relief was certainly demonstrated by investors. According to Cowen & Co. analysts, “the sector had its strongest rally since the Spring and the biotech indices kept pace with the broader markets."
With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
LONDON – The first of 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine arrived in the U.K., after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration beginning Dec. 8.
Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
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