Amgen, Inc.

FDA rejects Camurus' rare hormone disorder drug; Amgen to launch Eylea biosimilar in US after appeals court decision.

Amgen to launch biosimilar of Regeneron's Eylea after U.S. appeals court ruling in its favor.

The ADC market, driven by technological advancements and personalized medicine, is expected to reach ~USD 26 billion by 2030 with a CAGR of ~14%. North America leads due to high cancer incidence and strong biopharmaceutical sector. Key players include F. Hoffmann-La Roche Ltd, DAIICHI SANKYO COMPANY, LIMITED, and Pfizer Inc. The market is dynamic, influenced by regulatory frameworks and innovation in linker technologies and payloads.

Tolerance Bio, a biopharmaceutical company focused on thymus function manipulation, closed a $17.2 million seed financing round. The company aims to develop iPSC-based cell therapies and pharmacological treatments for immune-mediated diseases, including cancer and autoimmunity. The technologies were developed by a team with extensive experience in biopharma, including former executives from Provention Bio and Celimmune.

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.

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.

FDA delays decision on sotorasib plus panitumumab for chemorefractory metastatic CRC with KRAS G12C mutation to January 17, 2025, to review supplemental information. Supported by CodeBreaK 300 study data showing improved PFS, but OS trend not statistically significant.

Oprah Winfrey reflects on the impact of weight-loss drugs like Wegovy and Zepbound, which dominate the obesity market. The rise of GLP-1 drugs, initially for diabetes, has led to a 'silent revolution' in obesity treatment. Competition is heating up, with 16 new drugs expected by 2031. Small-cap companies like Viking Therapeutics and Terns Pharmaceuticals are emerging as key players, focusing on oral drugs and new therapeutic targets. Investors are advised to consider long-term efficacy and side effect management.