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The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
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.
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
In keeping with the 21st Century Cures Act, the U.S. FDA issued a draft guidance describing a standards recognition program for regenerative medicine therapies at the Center for Biologics Evaluation and Research that’s intended to facilitate the development of the therapies and reduce the regulatory burden.
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 lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
The European Commission and the U.S. Department of Health and Human Services (HHS) recently signed an arrangement to strengthen their cooperation on preparedness and response to public health threats.
Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week.
Winding down its current term, the U.S. Supreme Court on June 13 declined to hear appeals filed by Insys Therapeutics Inc. founder John Kapoor and former regional sales director Sunrise Lee.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
