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.
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.
As expected, the FDA granted approval for Comirnaty, the brand name that the companies have used in Europe for months, on 23 August, following the emergency use authorization granted in December 2020
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.
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.
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.
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.
At the Bank of America health care conference, pharma leaders speculated on what Trump’s executive order on drug pricing could mean for US and European drug prices.
The acquisition of Boston Pharma’s once-a-month FGF21 analog adds to GSK’s liver disease portfolio.
Vyepti revenues rise by nearly 70% in the first quarter.
