Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
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.
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.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
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 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, 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 now expected to start on Monday, Dec. 7.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
HONG KONG – Shanghai and New Jersey-based Lianbio has landed a commitment of up to $70 million in non-dilutive capital from a new collaboration with Pfizer Inc., just weeks raising $310 million in an oversubscribed crossover financing round.
