The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
Danish vaccines manufacturer Bavarian Nordic A/S is to be taken private in a DKK233 per-share deal valuing the company at DKK19 billion (US$2.97 billion). The deal needs the support of 90% of Bavarian Nordic shareholders to go through, and as things stand may not reach that target because it does not have the support of the largest shareholder, the Danish pension fund ATP, which owns 10.17%.
It’s not surprising that, of all the recommendations the U.S. CDC’s vaccine advisory board made at its June meeting, the first one Health and Human Services Secretary Robert Kennedy signed off on would essentially remove thimerosal from influenza vaccines in the U.S. What is surprising is the time it took for him to do so, given his long-held position on the preservative used in multidose vials and his insistence that a thimerosal presentation and vote be added to the agenda.
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
Respiratory vaccines specialist Vicebio Ltd. is to be acquired by Sanofi SA in a $1.6 billion deal, of which $1.15 billion will be paid up front. The acquisition rests on an ongoing phase I trial of the lead asset, VXB-241, a bivalent vaccine that is intended to provide protection against both respiratory syncytial virus and metapneumovirus. The interim analysis of the study showed a favorable safety and tolerability profile in adults, ages 60 and older, and validated the underlying vaccine technology, which is applicable to a wide range of respiratory viruses.
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
SK Bioscience Ltd. announced that the company has submitted an investigational new drug (IND) application to the South Korean Ministry of Food and Drug Safety.
As of May 2023, the WHO recommends the use of a monovalent XBB.1 descendent lineage, such as omicron XBB.1.5, as the vaccine antigen for COVID-19 vaccines. However, BA.2.86 and its descendent lineages, such as JN.1, have emerged and rapidly spread worldwide.
Led by the American Academy of Pediatrics, several medical groups went to court July 7 to force Health and Human Services Secretary Robert Kennedy to restore the CDC’s COVID-19 vaccine recommendations for pregnant women and healthy children ages 6 months to 17 years.
With no U.S. CDC director in place yet, Health and Human Services Secretary Robert Kennedy recently adopted two vaccine recommendations from the April meeting of the Advisory Committee for Immunization Practices (ACIP), making them official CDC recommendations and ensuring coverage of the vaccines for the specified populations.
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