Medilink announces global clinical trial collaboration and supply agreement on YL201 combination therapy
- MediLink and Amgen have entered a global clinical trial collaboration to evaluate YL201 and IMDELLTRAâ„¢ in extensive-stage small cell lung cancer (ES-SCLC).
- The Phase Ib study will assess safety, tolerability, pharmacokinetics, and efficacy of the combination therapy.
- IMDELLTRAâ„¢ has received accelerated FDA approval for ES-SCLC, contingent on confirmatory trials.
- The collaboration aims to explore a novel mechanism of action for potential clinical benefits in ES-SCLC.
Read more
Merck’s Keytruda meets primary endpoint in head and neck cancer trial
- The Phase 3 KEYNOTE-689 trial evaluated Keytruda as a perioperative treatment for stage III or IVA resected, locally advanced head and neck squamous cell carcinoma.
- Keytruda showed a statistically significant improvement in event-free survival (EFS) and major pathological response (mPR) compared to standard adjuvant radiotherapy.
- The safety profile of Keytruda was consistent with previous studies, with no new safety signals identified.
- Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
Read more
Scholar Rock reports apitegromab meets primary endpoint in phase 3 SAPPHIRE study in patients with spinal muscular atrophy
- Scholar Rock announced positive results from the Phase 3 SAPPHIRE trial for apitegromab in SMA patients.
- The trial met its primary endpoint, showing significant improvement in motor function with apitegromab versus placebo.
- Apitegromab was well-tolerated with no new safety concerns, consistent with previous trials.
- Scholar Rock plans to submit regulatory applications to the FDA and EMA in Q1 2025.
Read more
Pharmanovia acquires exclusive rights to treatment for Parkinson’s disease
- Pharmanovia has acquired exclusive rights to XADAGO (safinamide) for treating idiopathic Parkinson's disease in Australia and New Zealand.
- The agreement involves acquiring rights from CSL Seqirus, with Pharmanovia handling regulatory and commercial activities in the region.
- Pharmanovia will become the Marketing Authorization Holder (MAH) for XADAGO in these regions.
- This acquisition expands Pharmanovia's neurology portfolio, aligning with their strategy to enhance CNS offerings.
Read more
Ultragenyx receives breakthrough therapy designation for setrusumab in osteogenesis imperfecta
- Ultragenyx's setrusumab (UX143) received Breakthrough Therapy Designation from the FDA for treating osteogenesis imperfecta (OI) in patients aged 2 and older.
- The designation is based on positive results from the Phase 2 Orbit study, showing a significant decrease in fracture rates.
- Setrusumab has also been granted Orphan Drug Designation in the US and EU, and is part of the European Medicine Agency’s PRIME program.
- Ultragenyx and Mereo BioPharma are collaborating on the global development of setrusumab, focusing on pediatric and young adult patients.
Read more
Sage Therapeutics announces topline results from the Phase 2 LIGHTWAVE study of dalzanemdor in Alzheimer's disease
- The Phase 2 LIGHTWAVE study evaluated dalzanemdor in mild cognitive impairment and mild dementia due to Alzheimer's Disease.
- The study did not show a statistically significant difference in cognitive improvement compared to placebo.
- Dalzanemdor was generally well-tolerated with no new safety concerns.
- Sage Therapeutics will not pursue further development of dalzanemdor for Alzheimer's Disease.
Read more
Neuvivo seeks FDA approval for its breakthrough ALS treatment NP001
- Neuvivo has submitted a New Drug Application (NDA) to the FDA for NP001, a potential first disease-modifying therapy for ALS.
- NP001 targets ALS through an immunologic mechanism, aiming to restore balance in the body's immune system.
- The treatment has shown promise in Phase 2a, Phase 2b, and Overall Survival studies, potentially extending survival by up to a year.
- NP001 has received Orphan Drug and Fast Track Designations, making it eligible for Accelerated Approval and Priority Review.
Read more
MicuRx Pharmaceuticals announces promising results from MRX-5 study for treating Mycobacterium abscessus infections
- MRX-5, an oral oxaborole prodrug, shows significant potential in treating Mycobacterium abscessus infections.
- The study demonstrated MRX-5's efficacy against various M. abscessus isolates, including drug-resistant strains.
- At a dose of 15 mg/kg, MRX-5 achieved lung bacterial load reduction comparable to current therapies.
- MicuRx plans to initiate clinical trials to further evaluate MRX-5's safety and efficacy in human subjects.
Read more
Airsupra shows significant reduction in severe asthma exacerbations in BATURA Phase III trial
- The BATURA Phase IIIb trial demonstrated that Airsupra significantly reduced the risk of severe asthma exacerbations compared to albuterol alone.
- The trial included patients with intermittent or mild persistent asthma, using various maintenance therapies.
- Airsupra's safety profile was consistent with previous findings, with no new safety concerns reported.
- Data will be presented at the ACAAI Annual Scientific Meeting and shared with health authorities.
Read more
Cognito Therapeutics to present new data for Spectris in Alzheimer’s disease at CTAD 2024
- Cognito Therapeutics will present multiple poster presentations for Spectris at the CTAD 2024 conference in Madrid.
- Spectris is a non-invasive therapy using auditory and visual neuromodulation to target Alzheimer's disease.
- The HOPE study aims to enroll a diverse group of participants, reflecting the real-world Alzheimer's population.
- Key presentations include data on the preservation of brain function and structure, and participant diversity in the HOPE study.
Read more
