Week of May 9, 2016

Top Industry News

• Prescription medicines: New or extended uses of registered medicines
• Medical Device regulations in Russia
• The updated EU Harmonized technical eCTD guidance version 4.0
• CDISC announces Groundbreaking Clinical Trial Registry XML Standard
• Guideline on good pharmacogenomic practice
• Three FDA final rules slated for release in May
• Regulatory approval in India: An updated review
• CFDA proposes sourcing requirements for drug, device companies
• Top 10 pharmaceutical companies 2016
• EMD Serono expands Biopharmaceutical R&D facility in Billerica, MA to accelerate innovation

Mergers & Acquisitions

• AMRI to acquire Euticals in a strategic transaction that expands its API development and manufacturing business
• RXi Pharma and Thera Neuropharma enter license agreement
• Pro Mach acquires NJM packaging
• Marina Biotech to acquire late-stage program from Turing Pharmaceuticals