Amgen, Inc.

AstraZeneca's Tezspire shows significant reductions in nasal polyp size and congestion in Phase III WAYPOINT trial, offering potential new treatment for severe chronic rhinosinusitis with nasal polyps, reducing reliance on surgery and corticosteroids.

AstraZeneca and Amgen's TEZSPIRE® (tezepelumab) showed significant reduction in nasal polyps and congestion in Phase III WAYPOINT trial for chronic rhinosinusitis with nasal polyps (CRSwNP).

The Immunomodulators market is projected to grow from $248M in 2023 to $364.7M by 2030, driven by rising autoimmune diseases, advancements in biologics, and personalized medicine. Immunomodulators are crucial for treating immune-mediated diseases, with technological advancements expanding treatment options. The market segments include immunosuppressants, immunostimulants, and biologics, with biologics leading growth. Key regions like the U.S. and China show significant growth potential.

In 2024, smaller deals have dominated pharma M&A, with no single deal surpassing $5 billion. Despite this, M&A remains crucial for refilling pipelines and supporting smaller biotechs. Notable deals include Vertex's $4.9 billion acquisition of Alpine Immune Sciences, Eli Lilly's $3.2 billion acquisition of Morphic, and Gilead's $4.3 billion purchase of CymaBay. Oncology and neuroscience have seen significant activity, with Novartis and AstraZeneca leading in oncology, and Bristol Myers Squibb and Lundbeck in neuroscience.

Trump's victory may bring changes to federal health agencies, with potential influence from Robert F. Kennedy Jr. on healthcare policy. Trump's past FDA commissioners and COVID-19 actions suggest a mixed approach. Kennedy's potential role could shift focus to unorthodox medical science and regulatory reform. Industry concerns about FDA and FTC leadership changes, drug pricing policies, and U.S.-China biotech ties are heightened.

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®.

Verastem Oncology reported Q3 2024 financials, completed NDA submission for avutometinib/defactinib in recurrent KRAS mutant LGSOC, seeks accelerated approval with FDA decision expected by end of 2024 and potential approval by mid-2025. The company presented positive RAMP 201 trial data at IGCS 2024, showing robust response rates and low discontinuation due to adverse events. Financially, Verastem ended Q3 2024 with $113.2 million in cash and equivalents, total operating expenses of $37.0 million, and a net loss of $24.0 million, or $0.60 per share.

DelveInsight's 'Rosacea Pipeline Insight, 2024' report highlights 25+ key companies developing 25+ pipeline drugs for Rosacea, with therapies in various stages of clinical development. Key companies include Sol-Gel Technologies, Maruho Co., Ltd., AOBiome LLC, and others. Emerging therapies like Epsolay, M 1220, and BMX-010 are expected to impact the market. Regulatory approvals and collaborations are noted, such as Sol-Gel Technologies' agreement with Searchlight Pharma Inc. and Zydus Lifesciences' FDA approval for Metronidazole Topical cream.