Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease.
LONDON – A fourth COVID-19 vaccine is on the road to approval in Europe, with Novavax Inc. announcing positive interim data from the phase III U.K. trial of NVX-CoV2373. The vaccine was 89.3% effective at a time when there was a high rate of infection in the country, and in the face of the newly identified variant, B 1.1.7, which is more transmissible. There also was positive data, though slightly less sparkly, from a phase IIb study in South Africa, where NVX-CoV2373 showed 60% efficacy in preventing mild, moderate and severe COVID-19 disease.
In a move that will enable both a broadening of its portfolio and a strengthening of its IP position, Neubase Therapeutics Inc. has acquired technology from Vera Therapeutics Inc. for creating peptide-nucleic acid scaffolds. The deal will extend the ability of Neubase's Patrol platform, a tool for addressing the causal mechanism of genetic disease, to directly modulate the human genome to resolve both rare and common diseases, including cancers, the company said.
Innate Pharma SA’s unexpected return to partner Astrazeneca plc all rights, in the U.S. and EU, to Lumoxiti (moxetumomab pasudotox-tdfk) for hairy cell leukemia likely triggered unease in at least some investors.
In light of its ongoing restructuring of priorities, Medigene AG, of Planegg/Martinsried, Germany, is now discontinuing its MDG-1021 development program. The company was planning a phase I study of the T-cell receptor-modified T-cell (TCR-T) therapy that targets the antigen HA-1 in patients with relapsed or persistent blood cancers after allogeneic hematopoietic stem cell transplantation.
HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant, originally developed for allergic rhinitis, for the treatment of COVID-19 and age-related declines in immune function.
For at least the past decade – under both the Obama and Trump administrations, and perhaps even in previous administrations – the U.S. Department of Health and Human Services has been using the “Bank of BARDA” to routinely cover millions of dollars of unrelated spending at the Office of Assistant Secretary for Preparedness and Response, the U.S. Office of Special Counsel said in letters yesterday to President Joe Biden and Congress.
Little more than half-a-year after closing its $78 million series A financing, Artiva Biotherapeutics Inc. has inked a new global licensing deal with Merck & Co. Inc. to develop up to three natural killer (NK) cell therapies engineered with chimeric antigen receptors (CAR) against tumor-associated antigens of its choosing. Merck will pay Artiva $30 million up front for two initial programs, plus $15 million more should it opt into the third. Each program carries $612 million in potential development and commercial milestone payments. With unfettered success, total deal value could hit $1.88 billion, plus royalties.
The latest global regulatory news, changes and updates affecting biopharma, including: Biden orders review of scientific-integrity policies; Canada to build rare disease drug strategy; South African variant in U.S..
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