Goserelin

FDA Workforce Cuts Lead to Historic Drop in Medical Device Approvals

a month ago

• FDA approvals for high-risk medical devices fell to a ten-year low in Q1 2025, with only nine approvals despite an increase in pending applications. • More than 220 jobs were eliminated from the FDA's Center for Devices and Radiological Health in February, followed by additional cuts in April that affected approximately 10,000 HHS employees. • Industry leaders, including Medical Alley Association, have expressed concerns that the loss of experienced personnel will delay approvals, slow progress, and potentially undermine public trust in critical health infrastructure.

Canadian Scientist Dr. Daniel Drucker Wins Breakthrough Prize for GLP-1 Hormone Discovery Behind Ozempic and Mounjaro

2 months ago

• Dr. Daniel Drucker from the University of Toronto has been awarded a 2025 Breakthrough Prize in Life Sciences for his pioneering work on GLP-1, the hormone behind blockbuster weight-loss drugs Ozempic and Mounjaro. • The $3 million prize is shared with four international colleagues who contributed to GLP-1 research and drug development, recognizing four decades of work that has transformed treatment options for diabetes and obesity. • Beyond weight management, GLP-1 medications show promising potential for reducing cardiovascular events and may have applications for treating inflammation, arthritis, kidney disease, and Alzheimer's disease.

Ozempic Significantly Improves Walking Distance in Patients with Type 2 Diabetes and Peripheral Artery Disease

2 months ago

• Phase 3 STRIDE trial results show Ozempic (semaglutide) 1 mg increased maximum walking distance by 13% compared to placebo in patients with type 2 diabetes and peripheral artery disease. • Patients treated with semaglutide experienced a clinically meaningful median improvement of 26.4 meters in walking distance on a 12% incline, along with better pain-free walking and quality of life measures. • Based on these positive findings, Novo Nordisk has submitted a label extension application to the FDA, potentially making Ozempic the first new medication in over two decades to improve functional outcomes in PAD patients.

New Endometriosis Pill Ryeqo Approved for NHS Use, Offering Hope to 1.5 Million UK Sufferers

2 months ago

• A first-of-its-kind daily pill for endometriosis, relugolix combination therapy (Ryeqo), has been approved for NHS use in England after initially being rejected by Nice. • The breakthrough treatment works by blocking hormones that contribute to endometriosis while providing hormone replacement, offering a more convenient alternative to injectable treatments for approximately 1,000 patients annually. • Endometriosis affects 1.5 million women in the UK, causing debilitating pain and fertility issues, with diagnosis typically taking nine years from symptom onset.

Novel Peptide BRP Shows Promise as Alternative to Ozempic for Weight Loss with Fewer Side Effects

3 months ago

• Stanford Medicine researchers have identified a natural molecule BRP that matches Ozempic's weight loss effects while demonstrating fewer side effects in animal studies. • The newly discovered peptide BRP works through a distinct metabolic pathway, specifically targeting the hypothalamus rather than affecting multiple body systems like current GLP-1 medications. • In animal trials, BRP reduced food intake by up to 50% and led to significant fat loss without affecting muscle mass, showing potential as a more targeted obesity treatment.

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.

Studies Reveal Quality of Life Trade-offs with Androgen Deprivation Therapy in Prostate Cancer Treatment

3 months ago

• New research from ASCO GU Symposium demonstrates that both continuous and intermittent androgen deprivation therapy (ADT) show comparable survival rates but significant quality of life impacts in prostate cancer patients. • Patients receiving ADT with post-operative radiotherapy experienced significantly worse health-related quality of life scores, dropping from 69.6 to 62.8 over 59 months compared to non-ADT patients. • Studies emphasize the need for individualized treatment approaches, as longer ADT duration correlates with greater decline in patient well-being and global health scores.

Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment

3 months ago

• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss. • The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections. • FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.

GLP-1 Agonists Linked to Reduced Risk of 42 Health Conditions in Large Study

4 months ago

• A large observational study of nearly 2 million patients found that GLP-1 receptor agonists (GLP-1RAs) are associated with a reduced risk of 42 health conditions. • The study, which included 215,000 GLP-1RA users, showed benefits beyond glucose control and weight loss, including neurological and respiratory conditions. • While GLP-1RAs demonstrated broad benefits, the study also identified increased risks for certain conditions like kidney stones and low blood pressure. • Researchers emphasize the need for further studies to confirm these findings and understand the long-term effects of GLP-1RA therapy.

Bayer's Elinzanetant Shows Promise in Reducing Hot Flashes for Breast Cancer Patients

4 months ago

• Elinzanetant met primary endpoints in the Phase III OASIS 4 trial, significantly reducing the frequency of moderate to severe vasomotor symptoms (VMS) in women undergoing endocrine therapy for breast cancer. • The study also achieved secondary endpoints, demonstrating a reduction in the severity of VMS, improvements in sleep disturbances, and enhanced menopause-related quality of life compared to placebo. • Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist, representing a potential non-hormonal treatment option for VMS in breast cancer patients and women at high risk. • Bayer is advancing regulatory submissions for elinzanetant in the US, EU, and other global markets, with potential launch expected later this year, pending regulatory approvals.

Viking Therapeutics Initiates Phase 2 Trial of Oral VK2735 for Obesity

4 months ago

• Viking Therapeutics has commenced a Phase 2 clinical trial for oral VK2735, a dual GLP-1/GIP agonist, to treat obesity. • The VENTURE-Oral Dosing Trial will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy over 13 weeks in approximately 280 adults. • Prior Phase 1 data showed promising weight reductions up to 8.2% and encouraging tolerability with the oral tablet formulation of VK2735. • Viking plans to initiate Phase 3 development for the subcutaneous formulation of VK2735 in the first half of 2025, following positive Phase 2 results.

Arch Biopartners Advances AKI Programs: LSALT Peptide and Cilastatin Trials Progress

4 months ago

• Arch Biopartners' Phase II trial of LSALT peptide for cardiac surgery-associated acute kidney injury (CS-AKI) gains ethics approval in Ontario, with patient recruitment set to begin in Toronto. • A 700-patient Phase II trial (PONTiAK) evaluating cilastatin for preventing drug-induced AKI receives a No Objection Letter from Health Canada, paving the way for the trial to proceed. • Both LSALT peptide and cilastatin target the dipeptidase-1 (DPEP1) pathway, addressing significant unmet needs in preventing and treating AKI caused by inflammation or toxins. • These advancements highlight Arch Biopartners' commitment to developing innovative therapies for acute kidney injury and organ damage, with ongoing trials in Canada and internationally.

Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer

5 months ago

• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression. • DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy. • Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy. • This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.

Arch Biopartners Establishes Australian Subsidiary for Metablok Phase I Trial in Acute Kidney Injury

5 months ago

• Arch Biopartners has created Arch Clinical Pty Ltd in Australia to facilitate a Phase I safety trial for Metablok, a drug candidate targeting acute kidney injury. • The Phase I trial application has been submitted to the Alfred Health Human Research Ethics Committee, with a decision anticipated in early 2019. • The study will assess the safety and pharmacokinetics of Metablok (LSALT Peptide) in healthy participants through a double-blind, placebo-controlled design. • A successful Phase I trial will pave the way for a Phase II trial to evaluate Metablok's efficacy in preventing acute kidney injury in cardiac surgery patients.

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.

FDA Approves Ozempic for Reducing Kidney Disease Risks in Type 2 Diabetes Patients

5 months ago

• The FDA has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. • A Phase 3 clinical trial demonstrated a 24% reduction in the risk of kidney disease progression and cardiovascular death compared to placebo with Ozempic. • Ozempic is now the most broadly indicated GLP-1 receptor agonist, offering a new treatment option for millions of adults with type 2 diabetes and chronic kidney disease. • The approval was based on the FLOW trial, which showed significant benefits in kidney and cardiovascular outcomes, leading to early termination due to efficacy.

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.

Novartis' Kisqali Receives EC Approval for Early Breast Cancer Treatment

6 months ago

• The European Commission (EC) has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of HR+/HER2- early breast cancer. • The approval is based on the Phase III NATALEE trial, demonstrating a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone. • Kisqali is now approved for a broader population of early breast cancer patients in Europe, including those with node-negative disease at high risk of recurrence. • The decision follows positive recommendations and aligns with recent FDA approvals and NCCN guidelines, reinforcing Kisqali's role in early breast cancer treatment.

Lexaria's Oral Tirzepatide Study Achieves Dosing Milestone, Eyes on Data

6 months ago

• Lexaria Bioscience has completed dosing in a pilot study evaluating oral tirzepatide, a GLP-1/GIP receptor agonist, utilizing its DehydraTECH drug delivery platform. • The study involved nine healthy volunteers and assessed tolerability, blood absorption, and blood sugar control of the oral formulation compared to injectable tirzepatide. • Lexaria aims to demonstrate meaningful absorption rates of oral tirzepatide, which is currently only available in injectable form, potentially improving patient convenience. • Data analysis is expected in December, with results anticipated in January 2025, which could pave the way for further development of oral GLP-1 therapies.

Drug Development Updates