The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court.
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector.
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
In keeping with federal standards for classifying race and ethnicity data, the U.S. FDA issued a draft revision to broaden its 2016 guidance on the collection of such data in clinical trials.
Becoming the first treatment for children ages 1 to 11 with eosinophilic esophagitis (EE), Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) was cleared by the U.S. FDA on Jan. 25.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness.
Final rules the U.S. SEC adopted Jan. 24 to beef up disclosure requirements and investor protection in initial public offerings by special purpose acquisition companies (SPACs) and de-SPAC transactions could be the death knell for the SPAC market. They also could open the door for the SEC to regulate companies like biopharma and med-tech startups as investment companies.
What’s the status of the U.S. FTC’s investigation into pharmacy benefit managers’ (PBMs) role in prescription drug prices? Inquiring minds in the Senate really want to know, especially since the investigation began more than 18 months ago. “We urge the FTC to complete its 6(b) study in a timely manner,” 14 senators, led by Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.), wrote in a Jan. 22 letter to FTC Chair Lina Khan.
Quality-of-life claims in a TV ad for breast cancer drug Kisqali (ribociclib) earned Novartis AG the first untitled letter of 2024 from the U.S. FDA’s Office of Prescription Drug Promotion (OPDP).
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