Roche hands over another batch of positive PhIII data on its new flu drug, looking for an early-winter launch (Endpoints) (Reuters) (PMLiVE) (Fierce) (pharmaphorum)
Staggering Prices Slow Insurers’ Coverage Of CAR-T Cancer Therapy (KHN) (NPR) (STAT-$)
Industry responds to Trump's drug plan with more finger-pointing (Axios) (STAT-$) (GEN)
Takeda, Celgene Invest $6 Million in Presage Biosciences Cancer Testing Technology (BioSpace)
CytoDyn touts new data in drug-resistant HIV patients (BioPharma Dive)
Arcus Biosciences Announces Final Safety Results From Phase 1 Trial for AB928 in Healthy Volunteers (Press)
Viking Therapeutics Announces VK5211 Phase 2 Study Results Selected for Plenary Oral Presentation at ASBMR 2018 Annual Meeting (Press)
Voyager Therapeutics Receives FDA Guidance on Development Path for VY-AADC for Parkinson’s Disease and Provides Clinical Update (Press)
Asterias Provides Six Month Data Readout for its AST-OPC1 Phase 1/2a Clinical Trial in Severe Spinal Cord Injury (Press)
Medical Devices
Next-gen clinical decision support tools: Analytics and health data in the EHR workflow (Healthcare IT News)
MTaI organises 'Medical Packaging Seminar’ to educate professionals on new medical device rules introduced in Europe (Pharmabiz) (Business Standard)
Abbott’s St. Jude Medical must face negligence suit over Riata leads (MassDevice)
BD’s Bard wins third IVC filter bellwether (MassDevice)
Insulet settles shareholder suit over Omnipod Eros device (DDBN)
CeQur acquires Johnson & Johnson's Calibra insulin delivery patch (MobiHealthNews)
Medical device connectivity market could exceed $1B by 2022 (Healthcare Dive)
Quidel Receives FDA Clearance for Solana Bordetella Complete Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections (Press)
Liver cancer death rate in US surged 43% in 16 years (CNN)
Hospitals can save money on drugs without Washington’s help (STAT)
Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates (NPR)
Legal same-sex marriage helps gay men's health, research shows (NBC)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work. Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
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