COVID-19 boosters for the fall should contain an omicron component, the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) said June 28, voting 19-2 to make that recommendation.
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling.
An agreement has been reached in the U.K. to pay a fixed annual fee for two antibiotics, regardless of how often the drugs are prescribed, in a bid to prevent their overuse and slow the development of antimicrobial resistance.
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
Valneva SE has struggled to get its COVID-19 vaccine on the market, but efforts to get the first Lyme disease vaccine approved in years now appear firmly on track after partner Pfizer Inc. invested €90.5 million (US$94.9 million) in the project. New York-based Pfizer has been working with Saint-Herblain, France based Valneva on the Lyme disease vaccine since April 2020, when the big pharma bought into the development program for the vaccine candidate codenamed VLA-15 for $130 million.
Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18.
In May, Sidekick Health AB revealed an expanded partnership with New York-based Pfizer Inc. for autoimmune-related conditions. Now, it has joined forces with Eli Lilly and Co. to help patients battling breast cancer with its gamified platform. The companies plan to introduce the integrated digital therapeutic starting in July with the roll out beginning in Germany.
After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older.
A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an U.S. NDA submission for treating COVID-19. While some data for the oral antiviral fell short of statistical significance, other companies are not far behind Pfizer in their drive for FDA acceptance using similar approaches.
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling.
