Top Industry News
- Swissmedic- Procedure for Submitting Applications According to HMV4 Before 1 January 2019
- FDA- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
- ANVISA- Regulatory Impact Analyzes released
- FDA- The Special 510(k) Program
- ANVISA- Guidance on the term of validity of Medical Products
- FDA- Adaptive Design Clinical Trials for Drugs and Biologics
- HPRA- Guide to Batch-Specific Requests for Human Medicines
- Swissmedic- Revision of the Therapeutic Products Act (HMG): Publication of the Adapted Standard Documents and forms for Applications for Authorization
- FDA- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
- FDA- Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities Guidance for Industry
Mergers & Acquisitions
- Tusk Therapeutics to be acquired by Roche
- Cerecor to Acquire Ichorion Therapeutics
- ACEA Biosciences to be Acquired by Agilent Technologies
- Alexion to Acquire Syntimmune
- Nutriband Inc. Signs Acquisition Agreement of Carmel Biosciences and FDA Approved Prexxartan™
- Tris Pharma Expands ADHD Portfolio with Acquisition of NextWave Pharmaceuticals