Regulatory Focus™ > News Articles > 3 > Recon: CVS to Hire Former Lilly CFO to Run PBM Business

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

Posted 20 March 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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 $277 Billion (Forbes)
  • Proteostasis Therapeutics Announces Proposed Public Offering of Common Stock (Press)
  • Novartis: Building “boot camps” for immune cells near tumors (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA, industry ponder changes to clinical trials for rare disease treatments (STAT-$)
  • 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 Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • Abbott wins Japanese reimbursement nod for MitraClip (MassDevice) (Press)
  • AVITA Medical Announces Government Funded Clinical Trial of RECELL in China (Press)
India
  • 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)
Australia
  • 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)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
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.
 
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