Gonadorelin

Roche Launches Elecsys PRO-C3 Test for Precise Liver Fibrosis Assessment in MASLD Patients

15 days ago

• Roche has introduced the Elecsys PRO-C3 test, developed with Nordic Bioscience, to accurately assess liver fibrosis severity in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). • The innovative diagnostic solution delivers results in just 18 minutes on Roche's cobas analyzers, potentially reducing the need for invasive liver biopsies while distinguishing between different fibrosis severities. • With MASLD affecting approximately 30% of the population and causing one in every 25 deaths globally, this test arrives as new drug treatments for liver fibrosis are emerging, enabling timely intervention and appropriate disease management.

Medicus Pharma to Acquire Antev for $75 Million, Gaining Novel GnRH Antagonist for Prostate Conditions

24 days ago

• Medicus Pharma has entered a binding agreement to acquire Antev Ltd. for approximately $75 million in shares plus $65 million in contingent payments tied to future regulatory approvals. • Antev's lead candidate Teverelix, a next-generation GnRH antagonist, targets two indications: preventing acute urinary retention recurrence in BPH patients and treating prostate cancer in patients with high cardiovascular risk. • The combined market opportunity for both indications is estimated at $6 billion annually, with FDA-approved Phase 2b trials already in progress for both conditions.

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.

FDA Clears IND for Adcendo's Novel Tissue Factor-Targeting ADC in Advanced Solid Tumors

3 months ago

• Adcendo's ADCE-T02, a first-in-class Topoisomerase I inhibitor-based antibody-drug conjugate targeting tissue factor, receives FDA clearance to begin Phase I trials in advanced solid tumors. • The Tiffany-01 trial, currently recruiting in Australia and expanding to the U.S., will evaluate safety, pharmacokinetics, and preliminary efficacy of ADCE-T02 in patients with advanced solid tumors. • The drug's unique design aims to overcome limitations of existing tissue factor-targeting ADCs by offering an improved therapeutic window and better safety profile for multiple cancer indications.

ObsEva Seeks FDA Approval for Novel Uterine Fibroid Treatment with Flexible Hormone Therapy Options

3 months ago

• Swiss biotech ObsEva has submitted FDA application for linzagolix, a GnRH antagonist offering unique dosing flexibility for uterine fibroid treatment with or without hormone add-back therapy. • The drug demonstrated significant reductions in heavy menstrual bleeding in two Phase 3 trials (PRIMROSE 1 and 2), positioning it as a potential competitor to AbbVie's Oriahnn and Myovant's Myfembree. • If approved, linzagolix would be the first GnRH antagonist providing treatment options for women who cannot or prefer not to take hormone therapy, addressing an unmet need in fibroid treatment.

DSMB Endorses Safety of Foresee's CAMCEVI in Pediatric Precocious Puberty Trial

3 months ago

• Independent Data Safety Monitoring Board issues third positive recommendation for Foresee Pharmaceuticals' Phase 3 Casppian study of leuprolide (FP-001) in central precocious puberty, with trial at 75% enrollment. • CAMCEVI (leuprolide 42mg injectable emulsion), already approved for advanced prostate cancer, shows promising safety profile for six-month dosing in pediatric CPP patients. • Study completion anticipated in 2025, potentially offering a new long-acting treatment option for children with CPP, a condition affecting 1 in 5,000-10,000 children.

Endometriosis Clinical Trial Pipeline Shows Promise with 20+ Therapies in Development

4 months ago

• The endometriosis clinical trial landscape is robust, featuring over 15 companies developing more than 20 potential therapies. • Recent clinical trial activity includes positive Phase II results for Hope Medicine's HMI-115 and TiumBio's Merigolix, alongside Lisata Therapeutics' preclinical research. • Key companies like Kissei Pharmaceutical, Mithra Pharmaceuticals, and Organon are advancing novel treatments, including Linzagolix and Estelle, to address unmet needs. • These emerging therapies aim to improve pain management and overall outcomes for the estimated 190 million women affected by endometriosis worldwide.

Novo Nordisk's Amycretin Shows Promising Weight Loss in Phase 1b/2a Trial

4 months ago

• Novo Nordisk's amycretin, a GLP-1 and amylin receptor agonist, demonstrated significant weight loss in a Phase 1b/2a trial. • Participants on the highest dose of subcutaneous amycretin (20mg) experienced an average 22% body weight loss over 36 weeks. • The safety profile of amycretin was consistent with incretin-based therapies, with mainly mild to moderate gastrointestinal adverse events. • Novo Nordisk plans further clinical development of amycretin for adults with overweight or obesity, based on these encouraging results.

Breakthrough in Infertility Treatment: rhFSH-CTP Shows Promise in Clinical Trials

4 months ago

A novel long-acting recombinant human follicle-stimulating hormone, rhFSH-CTP, has demonstrated significant potential in improving infertility treatment outcomes. Clinical trials reveal that rhFSH-CTP can reduce the number of required injections, enhance patient compliance, and maintain therapeutic efficacy, marking a significant advancement in assisted reproductive technologies.

European Commission Approves GSK's Jemperli Plus Chemotherapy for Advanced Endometrial Cancer

4 months ago

• The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy for first-line treatment of advanced or recurrent endometrial cancer. • The approval expands the indication to include patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors, representing approximately 75% of cases. • The RUBY trial demonstrated a 31% reduction in the risk of death with Jemperli plus chemotherapy compared to chemotherapy alone, with a median OS of 44.6 months. • Jemperli, a PD-1 blocking antibody, is now an approved immuno-oncology-based treatment option for all patients with advanced endometrial cancer in the EU.

Higher-Dose Semaglutide (7.2 mg) Demonstrates Superior Weight Loss in STEP UP Trial

4 months ago

• A Phase 3b trial (STEP UP) of semaglutide 7.2 mg showed a statistically significant and superior weight loss compared to placebo at week 72 in adults with obesity. • Participants on semaglutide 7.2 mg achieved a 20.7% weight loss, compared to 17.5% with semaglutide 2.4 mg and 2.4% with placebo, when adhering to the treatment. • Approximately 33.2% of patients on the 7.2 mg dose experienced a weight loss of 25% or more, versus 16.7% on the 2.4 mg dose. • Semaglutide 7.2 mg showed a safety and tolerability profile comparable to the 2.4 mg dose, with mostly mild to moderate gastrointestinal adverse events.

Evaxion Biotech Completes Dosing in Phase 2 Trial of Personalized Cancer Vaccine EVX-01 for Advanced Melanoma

4 months ago

• Evaxion Biotech has completed dosing in its Phase 2 trial of EVX-01, a personalized cancer vaccine, for advanced melanoma treatment. • The trial evaluates EVX-01 in combination with MSD’s Keytruda (pembrolizumab), with each patient receiving a uniquely designed vaccine. • Interim data from the Phase 2 trial presented at ESMO 2024 showed a 69% overall response rate and a positive correlation between AI predictions and immune responses. • The company anticipates a full clinical data readout in the second half of 2025, with hopes that EVX-01 could become a new treatment option.

FDA Sets PDUFA Date for 3-Month Leuprolide Mesylate in Advanced Prostate Cancer

4 months ago

• The FDA has set August 29, 2025, as the PDUFA goal date for Foresee Pharmaceuticals' 3-month formulation of CAMCEVI (leuprolide mesylate) for advanced prostate cancer. • A phase 3 trial supports the NDA, demonstrating 97.9% of patients achieved and maintained testosterone suppression to castrate levels. • The 3-month formulation offers an alternative dosing schedule to the currently marketed 6-month version of CAMCEVI. • Foresee Pharmaceuticals anticipates a successful commercial launch of the 3-month CAMCEVI formulation upon potential FDA approval.

Global DNA Sequencing Market Set to Reach $106 Billion by 2034, Driven by Next-Generation Technologies

4 months ago

• The global DNA sequencing market is projected to grow from approximately $15 billion in 2024 to over $100 billion by 2034, with a CAGR of 14.9-21.7% according to market research firms. • Next-generation sequencing (NGS) dominates the market with over 87% share, while oncology applications represent the largest segment at 25.5% of the total market. • Technological advancements, reduced sequencing costs, and integration of artificial intelligence are accelerating adoption across clinical research, personalized medicine, and consumer genomics.

Orbis Medicines Raises €90M Series A to Advance Oral Macrocycle Drug Development

5 months ago

• Danish biotech Orbis Medicines has secured €90M ($94M) in Series A funding led by NEA, with participation from Eli Lilly and other investors, to develop oral alternatives to injectable biologics. • The company's proprietary ᶠCycles platform aims to overcome traditional challenges in macrocycle drug development, focusing on improving stability, absorption, and bioavailability. • Orbis is targeting validated biologic drug targets to create oral alternatives for patients, supported by strategic partnerships including a research collaboration with Vivtex utilizing their GI-ORIS platform.

NMD Pharma's NMD670 Receives FDA Orphan Drug Designation for Charcot-Marie-Tooth Disease

5 months ago

• NMD Pharma's NMD670, a novel oral small molecule, has been granted Orphan Drug Designation by the FDA for treating Charcot-Marie-Tooth disease (CMT). • NMD670 inhibits the skeletal muscle-specific chloride ion channel ClC-1 and is currently in Phase 2 trials for CMT types 1 and 2, affecting over 3 million worldwide. • The FDA's designation aims to incentivize the development of treatments for rare diseases, offering benefits like tax credits and market exclusivity. • NMD670 has shown promise in preclinical studies and a Phase 2 trial (SYNAPSE-CMT) is underway, with data expected in 2H/2025 through 1H/2026.

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.

FDA Approves Bavarian Nordic's Vimkunya, First Chikungunya Vaccine for Adolescents

5 months ago

• The FDA has approved Vimkunya, a chikungunya vaccine developed by Bavarian Nordic, for individuals aged 12 and older. • Vimkunya is the first virus-like particle (VLP) single-dose chikungunya vaccine approved in the U.S., offering a new preventative option. • Clinical trials showed Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days. • Commercial availability of Vimkunya in the U.S. is expected in the first half of 2025, with launches in key European markets anticipated.

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.

Global Biotechnology Market Projected to Reach USD 3.54 Trillion by 2033, Driven by Therapeutic Innovations

6 months ago

• The global biotechnology market is expected to grow from USD 1.68 trillion in 2024 to USD 3.54 trillion by 2033, representing a CAGR of 9.18%, according to Cervicorn Consulting. • Red biotechnology, focused on medical applications, is projected to reach USD 649.31 billion by 2033, with monoclonal antibodies dominating the product segment. • North America leads the global biotechnology market with the highest market share, while Asia Pacific is experiencing the fastest growth due to increasing investments and government support.

Drug Development Updates