Organon

Trump's health nominees, including CDC's Dave Weldon and FDA's Marty Makary, could bring significant changes. Merck's Winrevair showed positive results in a Phase 3 trial, while Cassava's sumifilam failed in Alzheimer's treatment. FDA approved BridgeBio's Attruby for ATTR-CM, priced lower than Pfizer's drugs. Singulair linked to mental health issues. Sarclisa trials highlighted racial disparities in clinical trial composition.

Daré Bioscience reports financial results for Q3 2024, highlighting progress in its development programs including Ovaprene®, Sildenafil Cream 3.6%, DARE-HPV, DARE-VVA1, and DARE-PTB1, supported by grants and strategic funding. The company anticipates significant milestones in 2025.

FDA accepts Ionis Pharmaceuticals' donidalorsen NDA for hereditary angioedema, sets PDUFA date for August 21, 2025. Clonidine hydrochloride extended-release liquid approved for ADHD in pediatric patients. PDUFA date for Dermavant's tapinarof cream extended to March 12, 2025. MenACWY vaccination program reduced meningococcal disease incidence by 59% among 11-23 year-olds.

FDA accepted Shanghai Henlius Biotech and Organon's BLA for HLX14, a denosumab biosimilar. Supported by phase 1 and 3 trials, HLX14 aims to replicate PROLIA/XGEVA's efficacy.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB-009P. Litigations continue between Amgen and biosimilar developers Celltrion, Samsung Bioepis, and Fresenius Kabi. Sandoz's Jubbonti®/Wyost® was approved as interchangeable with Prolia®/Xgeva®.

The PDUFA date for Organon's tapinarof cream, 1% to treat atopic dermatitis in adults and children aged 2 years and up, has been extended to March 12, 2025. The FDA requested final datasets from a long-term extension study, leading to a 3-month extension. Organon remains confident in the efficacy and safety data for tapinarof cream, 1%.

The FDA accepted Organon and Shanghai Henlius Biotech's BLA for HLX14, a denosumab biosimilar. HLX14 is intended for osteoporosis and bone mass increase in various patient groups. The BLA is supported by comparative quality and clinical studies. Organon has exclusive commercialization rights in the US, EU, and Canada. The FDA approved the first denosumab biosimilars, Wyost and Jubbonti, in March 2024.

At CIIE, Gilead Sciences submits market application for HIV drug lenacapavir, while Organon unveils SJ02, a long-acting FSH for infertility. Pfizer announces China approval for prostate cancer treatment Talazoparib, and Johnson & Johnson's Teclistamab Injection is approved for multiple myeloma.

Organon announced the FDA extended the review date for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis to March 12, 2025, from December 12, 2024. The extension was due to the FDA requesting additional datasets from a long-term extension study, with no concerns raised regarding safety and efficacy.