Eli Lilly & Co.

GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment

9 days ago

• GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion. • The acquisition includes an upfront payment of $1.2 billion, with potential for additional success-based milestone payments totaling $800 million. • This strategic move strengthens GSK's pharmaceutical portfolio in the liver disease therapeutic area, addressing significant unmet medical needs.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns

2 months ago

• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling. • European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions. • This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.

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.

Pirtobrutinib Shows Superior Efficacy in BTK Inhibitor-Pretreated CLL Patients

3 months ago

• Phase 3 trial demonstrates pirtobrutinib's superior progression-free survival compared to idelalisib or bendamustine plus rituximab in previously treated chronic lymphocytic leukemia patients. • Real-world evidence reveals a significant 10-month extension between progression-free survival and time to next treatment, suggesting enhanced clinical benefits beyond trial results. • Study findings position pirtobrutinib (Jaypirca) as a promising therapeutic option for CLL patients who have received prior BTK inhibitor therapy.

Landmark Prevention Trial Launches to Stop Alzheimer's Before Symptoms Begin in Young Adults

4 months ago

• WashU Medicine initiates groundbreaking international trial testing Eli Lilly's remternetug in young adults as young as 18, targeting Alzheimer's prevention up to 25 years before expected symptom onset. • The Primary Prevention Trial will enroll 240 participants from families with genetic mutations, focusing on removing or preventing amyloid beta plaques before cognitive symptoms develop. • The $130 million study represents a collaborative effort between academic institutions, pharmaceutical industry, and foundations, with support from NIH, Alzheimer's Association, and private donors.

Novo Nordisk's Amycretin Shows Promising Weight Loss in Early Trials

4 months ago

• Novo Nordisk's amycretin, a unimolecular GLP-1 and amylin receptor agonist, demonstrated a 22% average weight reduction in obese or overweight patients over 36 weeks. • The Phase 1b/2a trial of subcutaneous amycretin showed a favorable safety profile, with mainly mild to moderate gastrointestinal side effects reported. • These results have boosted investor confidence in Novo Nordisk's obesity drug pipeline, especially after previous disappointments with other candidates. • Amycretin combines GLP-1 and amylin receptor agonism in a single molecule, potentially offering a more effective approach to weight management.

Isomorphic Labs to Launch Clinical Trials for AI-Designed Drugs in 2025

4 months ago

• Isomorphic Labs, a Google DeepMind spinoff, anticipates initiating clinical trials for AI-designed drugs by the end of 2025, potentially revolutionizing drug discovery. • CEO Demis Hassabis aims to drastically reduce the drug discovery timeline from a decade to mere weeks or months using AI-driven approaches. • Isomorphic Labs has established strategic research collaborations with Eli Lilly and Novartis, signaling growing confidence in AI's role in pharmaceutical R&D. • The company's platform leverages DeepMind's AlphaFold AI to model molecular structures and predict interactions, accelerating the identification of promising drug candidates.

High-Dose Wegovy Shows Promising Weight Loss, Faces Stiff Competition

4 months ago

• A Phase III trial of a higher 7.2 mg dose of Wegovy demonstrated a 20.7% weight loss over 72 weeks, compared to 17.5% with the standard 2.4 mg dose. • While effective, the high-dose Wegovy results still lag behind Eli Lilly's Zepbound, which has shown over 20% weight loss in separate trials. • The trial indicated a safe and well-tolerated profile for the higher dose, with primarily mild to moderate gastrointestinal side effects. • Novo Nordisk anticipates further studies to explore the potential of higher doses in combination therapies like CagriSema.

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.

Retatrutide Shows Promising Weight Loss Results Compared to Other GLP-1 Agonists

5 months ago

• A recent study shows retatrutide, an investigational triple agonist, led to a 22.1% weight loss over 48 weeks, surpassing existing GLP-1 drugs. • Tirzepatide, commercially available as Zepbound, demonstrated a 17.8% weight loss over 72 weeks, highlighting its effectiveness in obesity management. • Semaglutide (Wegovy) resulted in a 13.9% weight loss over 68 weeks, while liraglutide (Saxenda) showed a 5.8% reduction over 26 weeks. • Oral semaglutide and orforglipron show promise in improving accessibility and adherence due to their non-injectable administration.

FDA Approves Zepbound as First Drug for Obstructive Sleep Apnea in Obese Adults

5 months ago

• The FDA has approved Zepbound (tirzepatide) as the first medication for treating moderate-to-severe obstructive sleep apnea (OSA) in obese adults. • Clinical trials showed Zepbound significantly reduced breathing disruptions and promoted weight loss compared to placebo, with nearly half of patients experiencing remission of OSA symptoms. • The drug is intended for use alongside a reduced-calorie diet and increased physical activity, offering a new approach to managing OSA and obesity. • While Zepbound shows promise, it's not suitable for all OSA patients, and continued weight loss is required for sustained effectiveness; common side effects include gastrointestinal issues.

Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial

5 months ago

• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults. • Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks. • The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration. • Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.

Lilly's Kisunla (donanemab-azbt) Receives Approval in China for Early Alzheimer's Treatment

5 months ago

• Eli Lilly's Kisunla (donanemab-azbt) has been approved in China for treating early symptomatic Alzheimer's disease in adults, marking its fourth major market approval. • The approval was based on the TRAILBLAZER-ALZ 2 Phase 3 study, which demonstrated a significant slowing of clinical decline in early-stage patients. • Kisunla is an amyloid plaque-targeting therapy that helps remove excessive amyloid plaques in the brain, potentially slowing memory and cognitive decline. • Lilly is partnering with DIAN-TU to investigate remternetug's potential in preventing amyloid plaque accumulation in early 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.

Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis

6 months ago

• Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older. • The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older. • The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2. • Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.