Amgen, Inc.

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.

After the Federal Circuit denied Regeneron's motion for an injunction pending appeal, Amgen launched its aflibercept biosimilar, PAVBLU, during its Q3 earnings call.

Vitrian invests $50M in AmplifyBio’s Ohio facility, aiming to scale to $65M, to support biomanufacturing in Central Ohio.

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.

The EU must update its regulatory framework to maintain biotech competitiveness, attract investment, and accelerate R&D, as highlighted by Amgen's innovative BiTE technology developed in Munich. Europe's biotech sector drives economic growth and global competitiveness but faces regulatory hurdles and rising costs. A stable, predictable regulatory environment is crucial for innovation, and the upcoming Biotech Act presents an opportunity to modernize regulations and foster a supportive ecosystem for medical advancements.

EMA accepts Alvotech and Advanz Pharma’s MAA for AVT05, a biosimilar to J&J’s Simponi for treating chronic inflammatory diseases. AVT05 targets TNF alpha, aiming to reduce costs and increase patient access. Positive clinical results in RA patients support its development, mirroring the global biosimilar market growth.

Viking Therapeutics' oral obesity drug showed 8% weight loss in 4 weeks, with 7% placebo-adjusted, and fewer GI side effects, sparking Wall Street interest. The Phase 1 trial results, from higher doses, suggest potential superiority over competitors like Wegovy and Zepbound. Viking plans Phase 2 study for oral drug and Phase 3 for injectable version.