1. The FDA will begin accepting applications on August 1 for a pre-certification pilot that aims to develop a regulatory framework for digital health innovation and medical technology. (MedCityNews)
2. FDA advisors reported more deaths among patients taking Johnson & Johnson’s experimental rheumatoid arthritis drug sirukumab than those taking a placebo. The agency is set to discuss whether the drug should be approved in two days. (Reuters)
3. AstraZeneca received FDA breakthrough status for its immunotherapy drug Imfinzi to treat non-metastatic lung cancer. The British drugmaker also hired two senior scientists to boost its oncology portfolio, despite setbacks inits MYSTICclinical trial of combinationtherapy of Imfinzi and tremelimumab last week. (Reuters)
4. Merck said the NotPetya cyber attack in June disrupted its manufacturing operations and will hurt its 2017 profits. (Stat)
5. Cardinal Health acquired Medtronic’s patient care, deep vein thrombosis and nutritional insufficiency unit for $6.1 billion. The business has 23 products, including vascular compression system Kendall and enteral feeding pump Kangaroo, both of which are used in U.S. hospitals. (Business Insider)
