Top Industry News
- FDA- M4E(R2): The CTD — efficacy guidance for industry
- TGA- Labelling changes: information for health professionals
- EMA- Revised guideline on first-in-human clinical trials
- TGA- Consultation: Alignment with European medical device regulatory framework
- CDSCO- NOTICE - Regarding Draft guidance documents on essential principles for safety and performance of medical devices as per medical devices rules 2017
- ICH Releases concept paper for planned guideline on collecting safety data
- FDA Updates on digital health plans, software pre-certification pilot
- FDA Finalizes GDUFA Q&A Guidance
- FDA updates on two ICH guidelines
Mergers & Acquisitions
- Baxter completes acquisition of Claris Injectables, expanding generic injectable medicines portfolio
- Sientra completes acquisition of Miramar Labs®
- Alpine Immune Sciences completes merger with Nivalis Therapeutics Inc.
- BriaCell expands targeted pipeline via acquisition of Sapientia Pharmaceuticals
- Mitsubishi Tanabe Pharma to acquire NeuroDerm Ltd.