PFIZER INC.

New entrants challenge Novo Nordisk and Eli Lilly in the $200 billion GLP-1 market, with 68% of sales from weight loss by 2031. Novo and Lilly expected to retain 70% of the market but are viewed as overvalued. Next-gen obesity drugs from Roche, Amgen, Pfizer, AstraZeneca, Boehringer, and others will disrupt the market, pressuring pricing. Novo and Lilly's next-gen pipelines also advancing. Public and private firms accelerating obesity drug development through acquisitions and innovative startups.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

Rimegepant (Nurtec ODT) is a CGRP receptor antagonist approved for acute and preventive migraine treatment. A pooled analysis of 4 trials showed rimegepant 75 mg outperformed placebo in pain freedom and symptom relief at 2 hours, with low adverse events. Early intervention, consistent use, and flexibility in treatment optimize rimegepant's effectiveness. Reduced rescue medication use suggests lower risk of medication overuse headache. CGRP-targeting treatments are increasingly recommended as first-line for migraine management.

UK-based Vicebio raised $100m in Series B funding led by TCGX to advance its RSV and hMPV vaccine VXB-241 to Phase I trials, utilizing its 'molecular clamp' technology for enhanced immune response.

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi.

5 in 6 Americans who tried to quit smoking in 2022 failed, highlighting ineffective treatments and lack of innovation. Despite the addiction killing 480,000 annually, no new class of drugs has been approved in nearly two decades. Drugmakers and the FDA are criticized for lackadaisical approaches and stringent approval standards, focusing more on profitable drugs for rare cancers. Advocates call for a 'Reduce to Quit' approach and more flexible FDA standards to address the public health crisis.

EMA’s CHMP recommended AbbVie’s ovarian cancer drug Elahere for approval in the EU, based on the MIRASOL study showing a 35% reduction in tumor progression or death. The EC will review this recommendation, with a decision expected later this year.

Biohaven's troriluzole shows promise in slowing spinocerebellar ataxia progression by 50-70% over 3 years in a clinical trial, outperforming natural history data. The company plans to submit an FDA approval application by year-end.

IDEAYA Biosciences reports positive Phase 2 darovasertib data in neoadjuvant uveal melanoma, with ~49% tumor shrinkage and ~61% eye preservation. A Phase 3 registrational trial is planned following FDA guidance, targeting ~400 patients. Annual incidence of primary UM in North America, Europe, and Australia is ~12k, with no FDA-approved therapies.

Over 1 billion people worldwide live with obesity, a global health crisis affecting all income levels. Treatments include lifestyle modification, pharmacotherapies, and bariatric surgery, but implementation gaps exist. Multidisciplinary approaches and patient-centricity are crucial for effective management and clinical trials, addressing social determinants of health and diverse patient needs.