The Oncologic Drugs Advisory Committee will review two drugs for sarcoma indications on March 20: Merck/Ariad’s Taltorvic (ridaforolimus) and GlaxoSmithKline’s Votrient (pazopanib). With a three-week median PFS advantage in its pivotal trial, ridaforolimus could face the same questions about clinically significant benefit that led to revocation of Avastin’s metastatic breast cancer claim.
The clinical significance of the progression-free survival benefit seen with Merck & Co. Inc./Ariad Pharmaceuticals Inc.’s investigational sarcoma treatment Taltorvic (ridaforolimus) is likely to be a key discussion point for FDA’s Oncologic Drugs Advisory Committee during its March 20 review of the mTOR inhibitor.
Ridaforolimus was associated with a median PFS benefit of three weeks in its pivotal trial, an advantage that FDA reviewers...
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
