Clinical Trial News
CDC Updates Guidelines on Doxycycline Post-Exposure Prophylaxis for STIs
• The CDC recommends doxycycline post-exposure prophylaxis (doxy PEP) for MSM and TGW with a recent history of bacterial STIs to reduce infection risk.
• Doxy PEP involves taking 200 mg of doxycycline within 72 hours after sex, but it should be part of a comprehensive sexual health strategy.
• Clinical trials have demonstrated significant reductions in chlamydia, syphilis, and gonorrhea among MSM and TGW using doxy PEP.
• Potential harms, including antimicrobial resistance, necessitate ongoing monitoring and further research to assess long-term effects.
Spineart Receives FDA 510(k) Clearance for SCARLET AC-Ti Anterior Cervical Cage with Advanced Ti-LIFE Technology
- Spineart announced FDA 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage, building on a decade of experience with the SCARLET system.
- The device features MIMETIX morphometric profile developed with digital vertebrae models to optimize implant-endplate contact surface and allows fixation with screws and anchors.
- SCARLET AC-Ti utilizes Spineart's proprietary Ti-LIFE additive manufacturing technology, creating a porous structure that closely mimics trabecular bone architecture.
- The approval represents Spineart's commitment to innovation and continuous evolution of their most successful spinal surgery products.
Johnson & Johnson to Acquire Yellow Jersey Therapeutics for $1.25 Billion, Bolstering Atopic Dermatitis Pipeline
- Johnson & Johnson will acquire Yellow Jersey Therapeutics for $1.25 billion, gaining rights to NM26, a Phase 2-ready bispecific antibody for atopic dermatitis.
- NM26 targets both IL-4Rα and IL-31, addressing inflammation and itch, potentially offering advantages over existing treatments like Dupixent.
- The acquisition aligns with J&J's strategy to expand its immunology portfolio with differentiated bispecifics, following recent deals in oncology and immunology.
- Numab Therapeutics' MATCH™ technology platform, used to develop NM26, is validated by this deal, highlighting its potential for creating novel multi-specific antibodies.
Rosacea Pipeline Analysis 2024: Insights into Therapeutics Development
The 2024 Rosacea Pipeline Analysis report by DelveInsight highlights the ongoing clinical development activities and growth prospects in the Rosacea Therapeutics Market. It details the involvement of over 25 key pharma and biotech companies, including Sol-Gel Technologies, in developing more than 25 pipeline drugs. The report covers various stages of clinical development, mechanisms of action, and molecule types, offering a comprehensive overview of the current and future landscape of Rosacea treatment.
RemeGen's Telitacicept Receives Priority Review for Myasthenia Gravis Treatment Following Successful Phase III Trial
- RemeGen's Telitacicept received priority review from China's NMPA for treating generalized myasthenia gravis after achieving its primary endpoint in a Phase III clinical trial.
- The dual-target fusion protein demonstrated favorable efficacy and safety profiles with continuous reduction of clinical symptoms in gMG patients compared to placebo.
- Myasthenia gravis affects approximately 1.146 million individuals worldwide, with around 217,000 in China, and currently has no definitive treatment available.
- Telitacicept has already received breakthrough therapy designation from China's NMPA and orphan drug plus fast track designations from the US FDA.
AI-Driven Drug Discovery Accelerates with New Academic Alliance Targeting Protein Kinases
- The Lamarr Institute, b-it, and TüCAD2 have formed a collaborative alliance to accelerate drug discovery using artificial intelligence, focusing specifically on protein kinase inhibitors that could treat cancer, neurological disorders, and autoimmune diseases.
- The partnership combines AI expertise in data analysis and machine learning from German research institutions with medicinal chemistry capabilities, utilizing the world's largest academic collection of 12,000 protein kinase inhibitors.
- AI technologies are revolutionizing drug discovery by reducing development timelines from 10-15 years and costs reaching billions of dollars, with applications spanning virtual screening, toxicity prediction, and de novo drug design.
- The collaboration emphasizes "Explainable AI" to ensure transparency and acceptance in medical applications, addressing the critical need for interpretable machine learning in pharmaceutical research.
FDA Grants Fast Track Designation to VCN-01 for Metastatic Pancreatic Cancer
- The FDA has granted Fast Track designation to VCN-01 in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic adenocarcinoma.
- VCN-01 previously received Orphan Drug Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) in June 2023.
- The ongoing phase 2b VIRAGE trial is evaluating intravenous VCN-01 with standard chemotherapy in first-line PDAC patients.
- VCN-01 is designed to selectively replicate within tumor cells, break down tumor stroma, and enhance the effectiveness of chemotherapy.
Highlighted Clinical Trials:
Innovent Biologics (Suzhou) Co. Ltd.
Posted 6/30/2024
Theriva Biologics SL
Posted 1/10/2023
Innovent Biologics (Suzhou) Co. Ltd.
Posted 10/26/2022
Vir Biotechnology to Present Latest Hepatitis Delta and B Data at EASL Congress 2024
Vir Biotechnology, Inc. announced that three abstracts featuring new data from its chronic hepatitis delta and chronic hepatitis B programs will be presented at the EASL Congress 2024. The presentations will include findings from the Phase 2 SOLSTICE trial, focusing on the efficacy and safety of tobevibart and elebsiran.
Highlighted Clinical Trials:
Vir Biotechnology, Inc.
Posted 9/17/2022
Biogen Expands into Immunology with Acquisition of HI-Bio
Biogen has announced its acquisition of Human Immunology Biosciences (HI-Bio) for $1.15 billion in cash, with potential additional payments of up to $650 million based on milestones. This move aims to diversify Biogen's pipeline, traditionally focused on neurology, by adding HI-Bio's lead drug, felzartamab, which has completed Phase 2 trials for kidney conditions. The acquisition is part of Biogen's strategy to reduce pipeline risk and explore new therapeutic areas under CEO Chris Viehbacher's leadership.
Immix Biopharma's NXC-201 Shows Promise as Outpatient CAR-T Therapy in Amyloidosis and Multiple Myeloma
- Immix Biopharma's NXC-201 has been administered to a significant number of patients with relapsed/refractory AL amyloidosis and multiple myeloma, showing potential in these challenging conditions.
- The company believes NXC-201 could offer a viable alternative for patients awaiting CAR-T cell therapies, potentially expanding access to a wider range of hospitals.
- NXC-201 is being developed as a potential outpatient CAR-T therapy, addressing limitations of current CAR-T treatments that are primarily administered in specialized centers.
- Immix Biopharma aims to address the limitations of current CAR-T therapies, which, despite generating substantial sales, are only accessible in a small percentage of U.S. hospitals due to side effects.