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Urothelial carcinoma treatment has evolved with FDA approvals of enfortumab vedotin-ejfv + pembrolizumab and nivolumab + cisplatin/gemcitabine. Personalized therapy is crucial as patients now live longer, but toxicity remains a challenge. Circulating tumor DNA (ctDNA) may help tailor treatment, and ongoing research explores combinations like sacituzumab govitecan + enfortumab vedotin. The landscape is rapidly changing, emphasizing the need for more biomarker research to guide treatment selection.

AstraZeneca and Amgen's Tezspire showed efficacy in reducing nasal congestion and nasal polyps in a Phase 3 trial for chronic rhinosinusitis. Jazz Pharmaceuticals plans to start an early-stage study for narcolepsy treatment JZP441 in 2024. Geron secured $250 million, potentially $375 million, for its myelofibrosis drug Rytelo. Aditum Bio and Leads Biolabs formed Oblenio Bio to develop a T cell engager for autoimmune diseases. Gilead Sciences halted Trodelvy development in second-line non-small cell lung cancer, resulting in a $1.8 billion write-down. Avid Bioservices is being taken private by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion deal.

The biopharmaceutical sector rebounded in Q3 2024, with top 20 companies seeing a 2% increase in market capitalization to $4.3 trillion. Bristol-Myers Squibb led with a 24.6% surge, driven by FDA approval of Cobenfy. Gilead Sciences rose 22.1% due to accelerated approvals for Livdelzi and Trodelvy. Sanofi's market cap jumped 19.2% on Dupixent's success. AbbVie gained 15.2% from immunology drugs. Alnylam Pharmaceuticals and Roche Holdings also saw significant growth. Novo Nordisk, Eli Lilly, and Merck faced declines.

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.

Gilead Sciences reported 7% Q3 revenue growth, with $7.5B in earnings surpassing forecasts. The company raised its full-year product sales guidance to $27.8B-$28.1B and adjusted profit forecast to $4.25-$4.45 per share. HIV sales grew 9% to $5.1B, driven by Biktarvy's 13% surge to $3.5B. Gilead plans to file for FDA approval of twice-yearly subcutaneous PrEP lenacapavir by end of 2024, aiming to expand its reach. COVID-19 antiviral Veklury contributed $692M, while oncology drug Trodelvy missed estimates by $8M despite 17% growth. Gilead's CAR-T therapy anito-cel showed a 95% overall response rate in multiple myeloma patients.

Antibody drug conjugates (ADCs) are a transformative class in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is expected to surpass $50B by 2030, driven by over 500 ADCs in clinical trials. Key players include Enhertu, Kadcyla, and Padcev, with significant sales in breast and lung cancers. The US and China lead the market, supported by robust R&D and regulatory environments.

Top 20 biopharmaceutical companies saw a 2% market cap increase in Q3 2024, driven by FDA approvals and strategic alliances. Bristol Myers Squibb led with a 24.6% growth, fueled by Cobenfy's approval and a $3.5bn deal with Prime Medicine. Gilead Sciences and Sanofi also grew significantly due to new drug approvals. Despite some declines, industry recovery is expected, supported by Federal Reserve interest rate cuts.

Gilead Sciences reported Q3 2024 revenue growth of 7% to $7.5 billion, with Biktarvy sales up 13% to $3.5 billion. Oncology sales rose 6% to $816 million. The company increased its full-year revenue, operating income, and EPS guidance. Product sales excluding Veklury grew 7% to $6.8 billion, driven by higher sales in HIV, Oncology, and Liver Disease.

The FDA's approval of Trodelvy for bladder cancer treatment has been withdrawn by Gilead Sciences due to TROPICS-04 study's failure to meet overall survival primary endpoint. This leaves fewer systemic therapy options for urothelial cancer patients, though Trodelvy remains approved for other cancer types. Patients currently on Trodelvy should consult their providers about continuing treatment.