ABBVIE

FDA approves fourth indication for AbbVie's Botox Cosmetic, expanding its use beyond facial wrinkles.

The FTC's 2023 revised merger guidelines impact pharmaceutical industries with stricter HHI and market share requirements, emphasizing direct evidence of market dominance and ecosystem competition. The FTC scrutinizes pharmaceutical mergers for market concentration, innovation, and entry barriers, with ongoing investigations into Novo Nordisk/Catalent and AbbVie/Cerevel mergers. The EC investigates Zoetis for potential abuse of dominance post-merger, and the FTC challenges fraudulent patents to prevent market monopolization. Pharmaceutical companies are increasingly merging with biotech firms to offset patent expirations and enhance product portfolios.

FDA approves Vyalev, a 24-hour subcutaneous levodopa infusion for advanced Parkinson's disease, showing superior motor fluctuation control compared to oral carbidopa/levodopa. AbbVie's Vyalev aims to provide continuous symptom management without surgery, with Medicare coverage expected in 2025.

FDA approves Avadel's sodium oxybate for pediatric narcolepsy, AbbVie's foscarbidopa/foslevodopa for advanced Parkinson's, and finds daily oral edaravone not superior in ALS treatment.

The FDA approved VYALEV, a 24-hour continuous infusion of levodopa-based medication for advanced Parkinson’s disease, offering a non-surgical alternative to oral medications. VYALEV, composed of foscarbidopa and foslevodopa, demonstrated superior improvement in motor fluctuations in pivotal and open-label studies, though it also showed common side effects like infusion site events, hallucinations, and dyskinesia.

Allergan Aesthetics announces FDA approval of BOTOX® Cosmetic for temporary improvement in moderate to severe platysma bands, expanding its indications to include forehead lines, frown lines, crow's feet lines, and now platysma bands.

Allergan Aesthetics, an AbbVie company, announces U.S. FDA approval of BOTOX Cosmetic for temporary improvement in moderate to severe vertical platysma bands in adults, expanding its aesthetic indications beyond the face.

Apremilast (Otezla) is now available for pediatric patients with moderate to severe plaque psoriasis, marking the first oral treatment approved for this age group. This development highlights the need for pediatric-specific research and the importance of addressing disparities in psoriasis care, particularly for patients with skin of color. Advocacy efforts by organizations like the National Psoriasis Foundation emphasize the significance of inclusive research and accessible treatments for all patients.

Study on MM treatment decision-making highlights QoL, duration of response, and side effects as top attributes for patients, care partners, and physicians. Differences in preferences and trade-offs underscore the importance of shared decision-making (SDM) to align treatment plans with patient values and improve outcomes.