AbbVie announced positive topline results from its Phase 3 TEMPO-2 trial for tavapadon, a potential new treatment for early-stage Parkinson’s disease. The drug significantly improved motor symptoms compared to a placebo, paving the way for a 2025 FDA submission.
Applied Therapeutics’ New Drug Application (NDA) for govorestat, a potential treatment for Classic Galactosemia, was rejected by the FDA. While the reasons remain unclear, this unexpected setback significantly impacts APLT stock and the future of the drug. However, the company’s ongoing SORD program remains unaffected and offers a potential path to future revenue.
Adial Pharmaceuticals has successfully completed a pharmacokinetic (PK) study of its drug candidate AD04 for Alcohol Use Disorder (AUD). This study, which met FDA requirements, provides crucial data for optimizing the design of upcoming Phase 3 clinical trials and potentially securing approval through a 505(b)(2) pathway. The results demonstrated that AD04 delivers lower ondansetron exposure than standard ondansetron tablets due to its lower dose, but exposure increases proportionally with dose and can be taken with or without food.
Rapt Therapeutics, Inc. (RAPT) saw its stock plummet by over 46% on Monday after the company announced the termination of its zelnecirnon (RPT193) program due to a serious adverse event (SAE) of liver injury. The program was being investigated in two Phase 2 clinical trials for asthma and atopic dermatitis, but both trials were placed on FDA clinical hold in February 2024. This decision followed a liver injury requiring a transplant in a patient participating in the atopic dermatitis trial. The company subsequently closed both studies and discontinued the zelnecirnon program, highlighting the challenges faced in drug development due to safety concerns. Rapt Therapeutics is now focusing on developing next-generation CCR4 compounds with improved safety profiles.
The FDA’s recent decision to impose a 2 ppm THC limit on hemp meal for animal feed is sparking controversy, drawing criticism for its lack of scientific justification and its potential to stifle the burgeoning hemp industry. This article delves into the history of the FDA’s relationship with hemp, explores the double standards in regulation, and argues for a science-based approach to hemp regulation.
The FDA has issued a warning and recall for Hologic Inc.’s BioZorb Marker products, implantable devices used for marking soft tissues. This follows reports of serious adverse events, including pain, infection, and device migration. The recall mandates the return of all unused BioZorb devices and advises healthcare providers on managing existing implants.
Eli Lilly has filed lawsuits against medical spas and online vendors for allegedly selling unauthorized versions of tirzepatide, the active ingredient in its weight-loss medication, Zepbound. This action comes despite the recent resolution of the FDA-declared tirzepatide injection shortage. Eli Lilly argues that these vendors are offering counterfeit products without FDA approval and are engaging in misleading advertising practices.
Gilead Sciences has announced the voluntary withdrawal of the accelerated approval for its cancer drug Trodelvy in treating locally advanced or metastatic urothelial cancer in the US. This decision, made in consultation with the FDA, follows results from a confirmatory Phase 3 study that did not meet the primary endpoint of overall survival. The withdrawal does not affect other approved indications for Trodelvy within or outside the US.
GSK’s investigational oral antibiotic, gepotidacin, for uncomplicated urinary tract infections (uUTIs) in adult and adolescent females has received Priority Review from the FDA. This could be the first new class of oral antibiotics for uUTIs in over 20 years.
Novavax Inc. (NVAX) shares plummeted on Wednesday after the FDA placed a clinical hold on the company’s Investigational New Drug (IND) application for its combined COVID-19/influenza vaccine candidate. The hold was triggered by a single instance of motor neuropathy reported in a participant outside the U.S., raising concerns about the vaccine’s safety.
