Eli Lilly CDR (CAD Hedged)

Samsung Biologics to Spin Off Biosimilar Business to Focus on Core CDMO Services

9 hours ago

• Samsung Biologics announced plans to establish Samsung Epis Holdings, which will incorporate Samsung Bioepis as a wholly owned subsidiary, separating its biosimilar development from CDMO operations. • The strategic spinoff aims to streamline operations by allowing each business to focus on their different revenue models, with final shareholder approval scheduled for September 16. • As one of the world's leading CDMO firms, Samsung Biologics reported impressive financial performance with $3.3 billion in sales and $1 billion in net profit in 2024.

Zura Bio Launches Phase II TibuSHIELD Trial for Novel Dual-Inhibitor in Hidradenitis Suppurativa

a day ago

• Zura Bio has initiated the Phase II TibuSHIELD trial evaluating tibulizumab, a first-of-its-kind dual inhibitor targeting both BAFF and IL-17A pathways in patients with moderate to severe hidradenitis suppurativa. • The global, randomized, double-blind, placebo-controlled study will enroll approximately 180 patients across the US, Canada, and Europe, with topline efficacy results expected in Q3 2026. • This trial represents Zura Bio's second Phase II study for tibulizumab, following the December launch of TibuSURE for systemic sclerosis, advancing their portfolio of treatments for severe inflammatory diseases.

Dementia Discovery Fund Secures $269M in Second Fund to Accelerate Novel Therapeutics Development

a day ago

• The Dementia Discovery Fund (DDF), managed by SV Health Investors, has closed its second fund with $269 million in commitments, bringing its total raised capital to over $550 million for dementia therapeutics development. • The fund has secured backing from previous cornerstone investors including AARP, British Business Bank, Gates Frontier, pharmaceutical giants Bristol Myers Squibb, Eli Lilly, and Pfizer, with the Alzheimer's Association joining as a new investor. • DDF-2 has already invested in four companies and aims to build a portfolio of 10-15 innovative biotech ventures across the UK, Europe, and US, addressing the urgent global challenge of dementia affecting over 50 million people worldwide.

Eli Lilly Considers $5.9 Billion Biomanufacturing Facility in Houston

3 days ago

• Pharmaceutical giant Eli Lilly is exploring a $5.9 billion biomanufacturing plant at McCord Development's Generation Park in Northeast Houston, potentially creating 600 permanent jobs and 2,000 construction positions. • The proposed 236-acre facility would be part of Eli Lilly's broader $50 billion U.S. manufacturing expansion since 2020, aimed at increasing production capacity for medicines including Mounjaro and Zepbound. • If approved, the project would deliver an estimated $2.5 billion economic impact over 10 years and strengthen Houston's emerging life sciences sector, supported by local biotech workforce development initiatives.

Persist AI Secures $12M Series A Funding to Revolutionize Pharmaceutical Formulation Development

3 days ago

• Persist AI has raised $12 million in Series A funding led by Spero Ventures to expand its AI-driven robotic laboratory for pharmaceutical formulation development. • The company's newly launched Cloud Lab platform enables pharmaceutical companies to remotely develop and test drug formulations, reducing traditional timelines from a year to just two months. • Persist AI's technology supports various drug modalities including peptides, small molecules, and antibodies, with plans to build a GMP manufacturing system for long-acting injectables in collaboration with Nivagen Pharmaceuticals.

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

3 days ago

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

Stylus Medicine Emerges with $85M to Revolutionize In Vivo Genetic Medicines

9 days ago

• Stylus Medicine has emerged from stealth with $85 million in financing to develop its platform combining sequence-specific genome integration with cell-targeted lipid nanoparticle delivery. • The company's technology aims to overcome limitations of ex vivo cell therapy manufacturing by enabling durable, flexible, and scalable in vivo cell engineering, with initial focus on CAR-T therapies. • Led by industry veterans Emile Nuwaysir (CEO) and Jason Fontenot (CSO), Stylus has secured backing from prominent investors including RA Capital Management, Khosla Ventures, Chugai Venture Fund, Eli Lilly, and Johnson & Johnson Innovation.

Zealand Pharma Appoints Utpal Singh as CSO to Advance Peptide Therapeutics for Obesity

a month ago

• Zealand Pharma has appointed Utpal Singh as Chief Scientific Officer to lead discovery research and translational sciences, bringing nearly 25 years of pharmaceutical industry experience to the company. • Singh will focus on integrating data science and machine learning with Zealand's peptide discovery expertise to develop innovative therapies targeting obesity and related complications. • The strategic appointment comes as Zealand Pharma aims to strengthen its position as a leader in peptide-based medicines, with the company currently having multiple candidates in late-stage development.

iLet Bionic Pancreas Shows Equal Efficacy in Primary Care and Specialty Settings for Type 1 Diabetes

2 months ago

• The iLet Bionic Pancreas automated insulin delivery system achieved target glucose levels in 97% of adults with type 1 diabetes, with no significant differences between primary care and endocrinology settings. • Researchers found the simplified device setup and management worked equally well via telehealth or in-person visits, potentially expanding access to advanced diabetes technology beyond specialty care. • The study demonstrated that primary care patients experienced greater improvements in hypoglycemia metrics compared to those under endocrinologist care, suggesting broader implementation possibilities.

Roche Expands Molecular Glue Portfolio with $2 Billion Monte Rosa Partnership

2 months ago

• Roche has signed a $2 billion partnership with Monte Rosa Therapeutics, including a $50 million upfront payment, to develop molecular glue therapies targeting previously "undruggable" proteins in cancer and neurological diseases. • This marks Roche's second major molecular glue deal in a month, following a similar $2 billion alliance with Orionis Biosciences, demonstrating the company's strategic push to establish leadership in this emerging therapeutic category. • Monte Rosa will lead discovery and preclinical activities using its QuEEN platform, with Roche taking over late-stage development of candidates that can potentially address the 80% of human proteins currently inaccessible to traditional drug development approaches.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

3 months ago

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups

3 months ago

• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability. • Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk. • The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.

New Analysis Shows Next-Gen Alzheimer's Drugs Add 8-10 Months of Independent Living

3 months ago

• WashU Medicine researchers have translated clinical trial data for lecanemab and donanemab into practical terms, showing these drugs can extend independent living by up to 10 months for early-stage Alzheimer's patients. • Patients with very mild symptoms could maintain independence for 39 months with lecanemab and 37 months with donanemab, compared to 29 months without treatment. • The study provides crucial decision-making information for patients and families, balancing treatment benefits against costs and risks including brain bleeds and swelling.

RNS60 Shows Promising Results in Phase 2 Stroke Trial, Reducing Brain Tissue Loss by 50%

3 months ago

• Revalesio's Phase 2 RESCUE trial demonstrated that RNS60 significantly reduced infarct growth by 50% in acute ischemic stroke patients treated within 12 hours of symptom onset. • The study showed correlation between reduced brain tissue loss and meaningful improvements in functional outcomes, measured by modified Rankin Scale, Barthel Index, and NIH Stroke Scale. • The double-blind, placebo-controlled trial evaluated two doses of RNS60 in 82 patients undergoing endovascular thrombectomy, positioning it as a potential first significant stroke therapy advancement in decades.

Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests

4 months ago

• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis. • Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology. • Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access. • These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.