The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Arrowhead, Avenue, Bausch, Cardiol, Clearside, Eyenovia, Merck & Co., PTC, Recce, Ridgeback.
LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: J&J, Kintor, Merck & Co., Moderna.
LONDON – A new National Security Act coming into force on Jan. 4, 2022, will extend the U.K. government’s power to scrutinize and intervene in foreign acquisitions and bring a swathe of domestic life sciences companies within the ambit of national security legislation for the first time.
Marking September as the second busiest month, 2021 is more than 6% ahead of last year in terms of reported clinical data, although the gap between the two years has narrowed significantly from 26% in April.
DUBLIN – Oncopeptides AB has withdrawn its troubled multiple myeloma
drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA. The move comes less than a week before the FDA’s Oncologic Drugs Advisory Committee was due to consider the drug’s safety profile because of data anomalies that surfaced over the summer.
Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, BMS, Currax, Glaxosmithkline, Intellia, Merck, Neuren, Regeneron, Sanofi, Sio, Small, Tetra, Tryp, Ultimovacs.
The push for legislation that would lower prescription drug prices in the U.S. has mounted in recent months, but support for Medicare pricing negotiations has faltered in the past few weeks. Sen. Bob Menendez (D-N.J.) is the latest Senate Democrat to signal his aversion to giving the government the authority to negotiate prices with drugmakers, breathing new life into hopes that the pharmaceutical industry will yet again escape a mechanism that critics say would suppress innovation at the expense of patients in desperate need of state-of-the-art therapies.
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