The US Food and Drug Administration’s full approval of Pfizer Inc./BioNTech SE’s COVID-19 vaccine BNT162b2, now Comirnaty, has expanded the companies’ options for marketing it.
Coronavirus Update: FDA Approves Pfizer/BioNTech's Comirnaty
The FDA granted an expected, though long-awaited, approval to the COVID-19 vaccine. Also, Korean regulators have begun a review of Russian vaccine CoviVac, while Bavarian Nordic has initiated a Phase II study of its vaccine booster candidate and received a commitment for up to DKK 800m from the Danish government.
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Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
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A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
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Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.
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Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.
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The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.
Recent moves in the industry include C-suite changes at 23andMe, Biomea Fusion & Alector, plus Bicycle Therapeutics acquires chief medical officer from ImmunoGen.
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Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.