Recon: CVS to Hire Former Lilly CFO to Run PBM Business

• Roche's Tecentriq notches third cancer cocktail trial win (Reuters) (Endpoints) (PMLiVE)
• DOJ weighing ‘major litigation’ against opioid makers, Trump says (STAT) (MedPage Today) (Politico) (WSJ) (CNN) (Bloomberg)
• Donald Trump promises (again) to slash drug prices substantially (Endpoints) (Reuters) (Bloomberg)
• Drug companies are beginning to wake up to this new risk factor (Marketwatch)
• Novartis enlists Harvard’s help in delivering second generation I-O drugs (The Pharma Letter-$) (Harvard School of Engineering and Applied Sciences)
• CVS to Hire Former Eli Lilly CFO to Run Pharmacy Benefit Business (WSJ)
• Arena bounces back. Stock soars on ozanimod rival’s PhII success (EP Vantage) (Endpoints) (Fierce)
• CMS Final Coverage Policy for NGS Cancer Panels Eases Some Lab Industry Concerns (GenomeWeb) (FDA Law Blog)
• Corporates pump yet more venture cash into medtech (EP Vantage)
• Just a Little Patience: In-licensing from Biopharma (Life Sci VC)
• Drug Products Labeled as Homeopathic; Draft Guidance for Staff and Industry, Extension of Comment Period (FDA)

• Mundipharma to market Herceptin biosimilar in key EU markets (pharmaphorum) (PMLiVE) (BioPharma-Reporter)
• Hearing: impact of endocrine disruptors on public health (European Parliament)
• GSK welcomes Brexit transition deal, but wants more ‘precision’ on final relationship (pharmaphorum)
• Medicxi founds biotech creation engine C21Med (Fierce)
• Provisional approval pathway: prescription medicines (TGA)
• State government links sponsors, sites and CROs in Australia (Outsourcing-Pharma)
• How does Canada’s health spending hold up to international scrutiny? (The Globe and Mail)
• Updated: Good pharmacogenomic practice (EMA)

• Bristol-Myers and Otsuka to face first trial over claims an antipsychotic pill caused compulsive behavior (STAT-$)
• Kerrisdale targets Proteostasis’ ‘ineffective’ cystic fibrosis drug in latest short attack (Fierce) (Endpoints)
• BIO Statement of Support for the Stronger Patents Act (Biotechnology Innovation Organization)
• Alzheimer's Costs Reach $277 Billion (Forbes)
• Proteostasis Therapeutics Announces Proposed Public Offering of Common Stock (Press)
• Novartis: Building “boot camps” for immune cells near tumors (Press)

• FDA, industry ponder changes to clinical trials for rare disease treatments (STAT-$)
• AstraZeneca touts a fresh cut of Farxiga data targeting diabetes patients with chronic kidney disease (Endpoints) (Press)
• Many common drugs, not just antibiotics, may kill off gut microbes (STAT-$)
• Possible Chlamydia Link with Ovarian Cancer (MedPage Today)
• Drug research priorities at odds with global disease toll (Nature)
• Kinase inhibitors: the road ahead (Nature)
• A human monoclonal antibody prevents malaria infection by targeting a new site of vulnerability on the parasite (Nature)
• The Medicines Company CEO, Dr. Clive Meanwell, On The Impact Of ODYSSEY OUTCOMES For Heart Patients (Forbes)
• U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) (Press)
• Progenics Pharmaceuticals Announces Presentation of AZEDRA (iobenguane I 131) Biochemical Tumor Marker Data at the 2018 Endocrine Society (ENDO) Annual Meeting (Press)
• Phase III IMpower131 Study Showed Genentech’s TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Reduced The Risk of Disease Worsening or Death in the Initial Treatment of People With a Type of Advanced Squamous Lung Cancer (Press)
• Mylan Adds to Growing Oncology Portfolio with Launch of Generic Mutamycin Injection (Press)
• Researchers puzzle over deadly heart condition tied to blockbuster cancer drugs (STAT-$)
• Elligo Health Research Raises $16M to Improve Access to Clinical Trials (Press)
• Anti-flu drug exploits weakness in H3N2 strain (Fierce)
• Time to Converge FDA Decisions and Evidence Syntheses for Long-Acting Muscarinic Antagonists and SMART in Guidelines for the Treatment of Asthma (JAMA)

• Medical device startups: Here’s how you handle regulatory and reimbursement (Medical Design & Outsourcing)
• Baxter completes $153M acquisition (Daily Herald) (MassDevice)
• FDA clears Edwards Lifesciences hypotension index software (MassDevice) (Press)
• BD to divest stake in Vyaire Medical to Apax Partners in $435m deal (MassDevice) (Press)
• Wright Medical, KFx settle patent spat, ink licensing deal (MassDevice) (Press)
• Medtronic touts one-year data on Arctic Front Advance cryoballoon (MassDevice) (Press)
• Nemours Children’s readies new specialty app for newborns with a rare heart defect (Fierce)
• Cook Medical’s Cellvizio receives further FDA 510(k) clearance (Press)
• Endologix Reports Positive Results from Global ENCORE Analysis with Polymer Endovascular Aneurysm Repair (EVAR) Using Ovation Abdominal Stent Graft Systems (Press)
• Connectiv and Asimily Team Up for Complete Medical Device Management (Press)
• Partners HealthCare Expands Use of Kyruus Technology Across Its Network to Enhance Patient Access (Press)
• Co. Did Not Warn Of Mesh Product Risks, NJ Jury Told (Law360-$)
• FDA to review pSivida’s ocular drug-delivery system (Drug Delivery Business News)
• Restoration Robotics™ Receives US FDA 510(k) Clearance for Implantation Function (Press)
• Balt USA, LLC Announces 510(k) Clearance of the Optima Coil System and New Balt USA Headquarters (Press)
• Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance (Press)

• Congress struggles to meet deadline for government funding bill (Reuters)
• Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (FDA)
• FDA seeks data on role of flavors in tobacco addiction (Reuters)
• Throwing the smirking Shkreli in prison won’t lower drug prices (Miami Herald)
• The One-Year Anniversary of the Oncology Center of Excellence (FDA Voice)

• FDA Advisory Committee Calendar
• CDER and You: Keys to Effective Engagement (FDA)

• Workshop on Paediatric Regulation – stakeholders to discuss how to boost development of medicines for children (EMA)
• MPS Call on U.K. Government to Resolve Orkambi Impasse (BioCentury)
• AkzoNobel Specialty Chemicals, DSM, Google and Philips receive first power from new Dutch wind farm Bouwdokken (Press)
• New funds for accumulation of knowledge about medicinal cannabis (Danish Medicines Agency)
• NHS to launch year-long independent review of online doctor service (pharmaphorum)

• Abbott wins Japanese reimbursement nod for MitraClip (MassDevice) (Press)
• AVITA Medical Announces Government Funded Clinical Trial of RECELL in China (Press)

• Exclusive: Faced with Delhi's pollution, India's federal agencies bought air purifiers (Reuters)
• New diabetes management guidelines may have substantial impact in India, warn doctors (Times Now)
• Why India’s development depends on the government fixing the education and health sectors (Qrius)
• Govt not using patent law effectively: Pharma body (Times of India)

• Medical Devices Safety Update Volume 6, Number 2, March 2018 (TGA)
• Arthrem capsules: Safety advisory – potential risk of harm to the liver (TGA)
• Senator says doctors could need 'expertise' to identify gender issues raised in mesh inquiry (The Herald)
• Australian Digital Health Agency announces first My Health Record connected town (OpenGov)
• Conference participation by the TGA (TGA)

• Certificates of Supplementary Protection (CSP) and Applications (Health Canada)
• Drug and health product submissions under review (SUR) (Health Canada)
• Canada Details Packaging Rules Ahead of Marijuana Legalization (Bloomberg) (Health Canada)
• Big Pharma's Entry Into the Cannabis Market (Lexology)
• Fraser Institute News Release: Canada’s health-care system stands in stark contrast to more successful universal systems around the world (Press)
• Diabetes Canada hopeful 'investments in people's health' will be renewed (CBC News)
• Cipher Pharmaceuticals and Cardiome Pharma Announce Strategic Transaction for Canadian Business Portfolio of Cardiome (Press)

• Older Adults Projected To Outnumber Children For First Time In U.S. History (Forbes)
• Mississippi bans abortions at 15 weeks, earliest in the nation (CNN)
• When towns lose their newspapers, disease detectives are left flying blind (STAT)
• I experienced trauma working in Iraq. I see it now among America’s doctors (STAT)