Friday, December 6, 2024

CATEGORY

EMA

European Agency Launches New Platform to Monitor Drug Shortages

Key TakeawaysFacilitates centralized reporting, reducing administrative burdens on MAHs Enhances real-time data availability for quicker response to shortages Improves coordination between EMA, national...

European Medicines Agency Champions Real-World Data for Safer Medical Practices

key TakewaysStreamlined access to RWD can accelerate medical research and regulatory approvals. Implementing Target Trial Emulation reduces bias, leading to more accurate conclusions. ...

Bristol Myers Squibb Gains CHMP Nod for Opdivo-Yervoy Combo in Metastatic Colorectal Cancer

Key TakeawaysOpdivo-Yervoy combination offers a novel first-line treatment option for MSI-H/dMMR metastatic colorectal cancer. Enhanced survival rates could set a new standard in...

Bristol Myers Squibb Advances Dual Immunotherapy for Colorectal Cancer

Key TakeawaysPositive CHMP opinion for Opdivo® and Yervoy® as first-line treatment for metastatic colorectal cancer. The CheckMate -8HW trial showed a 79% reduction...

CVMP Drives Veterinary Advancements with New Approvals and Guidelines

Critical Takeaways Key insights from the CVMP meeting include:Carprofen Orion stands out as a versatile solution for managing pain in pets during surgery. Revisions...

Dupixent Gains EU Approval for Young EoE Patients

key TakeawaysDupixent is now the first approved treatment for young EoE patients in the EU. The medication showed significant improvement in disease symptoms...

EU CHMP Recommends AstraZeneca’s Wainzua for Rare Neuropathy Treatment

Key TakeawaysAstraZeneca’s Wainzua (eplontersen) recommended for EU approval for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) with polyneuropathy. NEURO-TTRansform trial shows Wainzua improves neuropathy impairment...

Regulators Push for Coordinated Mpox Vaccine Trials

Recent global health concerns have spotlighted mpox, a viral disease endemic to parts of Central and West Africa, as a significant threat. As cases...

Pliant Therapeutics’ Bexotegrast Shows Promise in Treating Liver Disease

In a notable advancement, Pliant Therapeutics, Inc., a prominent player in the biotechnology sector focused on fibrotic disease treatments, has announced promising results from...

EMA Recommends Approval of Ten New Medicines, Enhancing Healthcare Options Across Europe

Key TakeawaysThe European Medicines Agency (EMA) has recommended ten new medicines for approval, addressing a wide range of medical needs across the EU. ...

European Parliament’s Bold Stance Strengthens EU Health Investments

In a decisive move that underscores the European Union's commitment to health and research, the European Parliament has voted against the proposed budget cuts...

EMA Confirms Non-Renewal of Translarna for Duchenne Muscular Dystrophy

Key TakeawaysThe EMA has reaffirmed its decision not to renew the marketing authorisation for Translarna, citing insufficient evidence of its efficacy in Duchenne...

Novartis’ Kisqali Poised to Expand Treatment Options for Early Breast Cancer in Europe

Key Takeaways Novartis' Kisqali® (ribociclib) has received a positive opinion from the European Medicines Agency's (EMA) CHMP, marking it as a potential treatment for hormone...

Alhemo® Receives Positive Recommendation for Haemophilia Treatment in Europe

Key TakeawaysNovo Nordisk's Alhemo® (concizumab) has received a positive opinion from the European Medicines Agency (EMA), marking it as the first once-daily subcutaneous...

EMA and HMA Launch Strategy to Boost EU Medicines System by 2028

Key TakeawaysTearCare treatment significantly improves reading speed and vision-related quality of life in patients with dry eye disease. Patients report improved visual function,...

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