Eli Lilly and Co

EVA Pharma's insulin glargine injection, produced in collaboration with Eli Lilly, received approval from the Egyptian Drug Authority. This marks the first regulatory approval for EVA Pharma's insulin drug products, aiming to provide affordable insulin to one million people in low- to middle-income countries annually by 2030.

Eli Lilly plans to launch Tirzepatide (Mounjaro) in India by 2025 for treating type 2 diabetes and obesity, competing with Novo Nordisk's Ozempic. The company aims to reflect the drug's efficacy in its Indian pricing strategy. India, known as the diabetes capital, is a key market for Lilly, which is committed to addressing unmet needs with innovative products. Tirzepatide, a dual agonist, may offer greater weight loss benefits than semaglutide, but experts warn against misuse as a cosmetic product.

Eli Lilly's Prevail Therapeutics is evaluating PR001, an AAV9 gene therapy for Parkinson's disease with GBA1 mutations in the PROPEL trial. The open-label, ascending dose study, initiated in 2020, includes one-time PR001 treatment with methylprednisolone and optional sirolimus. The trial, recruiting in the U.S. and Israel, has a 2029 completion date and primary end points include treatment-emergent adverse events and immunogenicity. Additional studies evaluate PR001 for type 2 Gaucher disease.

Novo Nordisk's acquisition of Catalent's manufacturing sites may resolve Wegovy supply issues but raises concerns for the pharmaceutical industry, as Novo Holdings now controls a major contract manufacturer.

Pharma and biotech stocks like Viking Therapeutics, Vertex Pharmaceuticals, and Pfizer could be top performers by 2030 due to promising drug developments and market expansions.

Big Pharma increasingly adopts direct-to-consumer (DTC) platforms, with Eli Lilly launching LillyDirect and partnering with Amazon, and Pfizer introducing PfizerForAll. OptimizeRx's Theresa Greco highlights privacy/compliance, data proliferation, and tech application as key trends shaping DTC in healthcare. AI and multiparty data enhance patient profiling and messaging timeliness, crucial for personalized, timely patient engagement.

Novo Nordisk's expansion of weight-loss drug supply and potential launch of new, more powerful drugs could revive GLP-1 drug interest in 2025. The acquisition of Catalent will boost production capacity, meeting demand and increasing revenue. A successful Phase III trial of CagriSema could give Novo Nordisk a competitive edge. GLP-1 drugs may impact alcohol sales negatively but benefit retailers like Walmart and health-conscious brands like Danone.

Eli Lilly announced the EMA's CHMP issued a positive opinion for Omvoh (mirikizumab), intended for adults with moderately to severely active Crohn’s disease. Omvoh, an IL-23p19 antagonist, was previously approved for ulcerative colitis. The positive opinion is supported by Phase 3 VIVID-1 study data, showing significant improvements in clinical remission and endoscopic response. Regulatory decisions for Crohn’s disease treatment are expected in 2025.

The clinical trial market, valued at USD 50.66M in 2023, is projected to reach USD 75.72M by 2032 with a CAGR of 5.91%. Factors driving growth include high R&D expenditure, rising disease prevalence, and demand for personalized medicine. Trends like decentralized trials and regulatory support from agencies like FDA and EMA are enhancing market efficiency. Key players include Sanofi SA, Novo Nordisk AS, and Pfizer Inc. Challenges include operational costs and stringent regulations.

EMA's CHMP recommended Eli Lilly’s Omvoh for EU approval to treat moderately to severely active Crohn’s disease. Omvoh, an IL-23p19 antagonist, is already approved for ulcerative colitis in the US, Japan, and the EU. The recommendation is based on Phase III VIVID-1 trial outcomes, marking progress towards full EU regulatory endorsement.