Top Industry News
- SFDA-Drug Master File: Guidance for Submission
- TGA - Target processing timeline for MRA GMP clearance applications
- Medicines and Healthcare products Regulatory Agency Business Plan 2017-18
- FDA - Advancing the safety of imported food
- FDA requires label changes to better protect children from Pain and Cough Medicines
- Medical device stand-alone software including apps (including IVDMDs)
- MHLW Pharmaceuticals and Medical Devices Safety Information (FY2017)
- EMA-Revised guidelines to encourage development of veterinary medicines for minor uses and minor species
- HPRA to host the WHO international conference of Drug Regulatory Authorities (ICDRA) in 2018
Mergers & Acquisitions
- PLx Pharma and Dipexium Pharmaceuticals complete merger
- Ionis enters into collaboration with Ribo to advance RNA-Targeted therapeutics in China
- PTC Therapeutics completes acquisition of Emflaza™ for the treatment of Duchenne Muscular Dystrophy in the U.S.
- Allergan expands leading research & development NASH Program with Novartis clinical collaboration