Mitsubishi Tanabe Pharma Corp.'s Medicago Inc. plans to "imminently" seek Health Canada approval for its plant-based COVID-19 vaccine candidate, MT-2766, after top-line phase III results showed an overall vaccine efficacy rate of 71% against all variants of SARS-CoV-2.
LONDON – New research shows the extent to which an individual’s immune response to the SARS-CoV-2 virus is affected by which variants they are initially exposed to, a finding that has consequences for attempts to update vaccines against emerging variants of concern.
LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial.
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market.
Whether it’s the highly mutated Omicron variant emerging in South Africa as biopharma researchers scramble to create custom-made vaccines in record time or the institutional mandates juxtaposed with waning vaccine immunity and the ongoing ups and downs of cases and deaths, the SARS-CoV-2 virus continues to dig its ugly spikes into an uncertain and anxious world.
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
RSS
