Regulatory Focus™ > News Articles > 4 > Recon: CVS Tool to Combat Drug Prices, Alexion Inks $855M Deal to Buy Wilson

Recon: CVS Tool to Combat Drug Prices, Alexion Inks $855M Deal to Buy Wilson

Posted 11 April 2018 | By Ana Mulero 

Recon: CVS Tool to Combat Drug Prices, Alexion Inks $855M Deal to Buy Wilson

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

In Focus: US [Sponsored Content] Five Ways a Graduate Degree Advances Your Regulatory Career

In Focus: International Pharmaceuticals & Biotechnology
  • Biotech M&A is ripping along now as IPOs surge and venture cash flows. Who’s the next big target? (Endpoints)
  • Senator says pharma should've cut prices with tax savings, but many companies went the other way (Fierce)
  • Insurers look to pass drug price breaks straight to consumer (STAT)
  • Another venture funding surge sets up a strong 2018 (EP Vantage)
  • 'Pharma bro' fraudster Martin Shkreli ordered to pay $388,000 in restitution to swindled investor (CNBC)
  • Biogen and the badly needed gene therapy acquisition that got away (STAT-$)
  • Drug company payments appear to influence oncologists’ prescribing habits (STAT-$)
  • Drugmakers Assail FDA For Nixing Generic Laxative Approval (Law360-$)
  • JDRF, ADA and Helmsley Charitable Trust Issue Request for Proposals to Research Consistency and Potency of Insulin Purchased in U.S. Pharmacies (JDRF)
  • Future of Injectables Could Be Needle-Free Delivery Systems (Pharmacy Times)
  • Dyve Biosciences Launches with Groundbreaking Therapeutic Dermal Delivery Technology (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Kadmon gets FDA go-ahead for ROCK2 inhibitor study (BioPharma Dive)
  • Arrowhead RNAi drug clears hepatitis B antigen in clinic (Fierce)
  • 6-month liver disease data reinforces CymaBay's phase 3 move (Fierce)
  • Molecular Partners gets AZ support for lung cancer trial (Fierce)
  • BiondVax, NIAID kick off phase 2 universal flu vaccine study in U.S. (Fierce)
  • Researchers Just Proposed a Radical New Way of Defining Alzheimer's. Could It Lead to Better Drugs? (Fortune)
  • Just How Smart Is Smart Medicine? MIT Scientists Are About To Find Out (Forbes)
  • Veracyte, Loxo Oncology Partner on Drug Development Research (GenomeWeb) (Press)
  • Nektar Announces Dosing of First Patient in Phase 1/2 Clinical Study to Evaluate Combination of TLR Agonist NKTR-262 with CD122-Biased Agonist NKTR-214 in Patients with Advanced Solid Tumors (Press)
  • CymaBay Announces Positive New 12-Week and 26-Week Results from its Ongoing Phase 2 Study of Seladelpar in Patients with Primary Biliary Cholangitis at The International Liver Congress 2018 (Press)
  • Arrowhead Pharmaceuticals Presents ARC-520 Clinical Data at The International Liver Congress (Press)
  • Zealand and Roche Diabetes Care enter Phase 3 study collaboration for treatment of congenital hyperinsulinism with dasiglucagon (Press)
Medical Devices
  • Abbott launches study comparing OCT to angiography in stent placement procedures (MassDevice) (Press)
  • Altaris Capital shells out $1.1B for health imaging maker Analogic (Fierce)
  • Soterix touts transcranial stim depression trial results (MassDevice)
  • Oracle launches cloud-based mHealth clinical trial data collection system (MassDevice)
  • Medical Device Startup Confirms B2B Sales Strategies (Forbes)
  • Opternative to launch white-labeled online eye exam for providers (MobiHealthNews)
  • New device would allow blood-free monitoring of blood sugar levels (Reuters)
  • UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication (FDA)
  • Guardian Connect System – P160007 (FDA)
  • TransMedics, Inc. TransMedics OCS Lung System – P160013 (FDA)
  • HeartSine samaritan SAM 350P, SAM 360P, and SAM 450P PADs and Accessories – P160008 (FDA)
  • LENSAR Laser System Receives FDA Clearance to Perform Corneal Pockets and Flaps for Corneal Inlay Procedures (Press)
  • TearLab Provides Update on 510(k) Filing for U.S. FDA Clearance of TearLab Discovery Platform (Press)
US: Assorted & Government
  • NIH director: Agency is looking at alcohol industry influence ‘in a very aggressive way’ (STAT)
  • CDC Probes Mysterious E. Coli Outbreak in 7 States; New Jersey Has Most Cases (NBC) (FDA)
  • Pay gaps persist for female and African American physicians in US (Reuters)
  • U.S. death rates falling, but health gains bypassing some states (Reuters)
  • Bill Gurley, who invested in Uber and other tech giants, sees opportunities to fix health care's broken business model (CNBC)
  • Congress isn't doing enough on opioid treatment, experts say (Axios)
  • Former Surgeon Charged With Impersonating Doctor (Law360-$)
  • More lawmakers question FDA over probe into Floridians importing medicines (STAT-$)
  • Humana Buys More Doctor Practices Amid Walmart Speculation (Forbes)
  • Will Theranos Survive The Summer? (Forbes)
  • House Democrat wants to know why a pharma insider is overseeing Trump’s drug pricing reform (Vox)
  • FDA Cracks Down on Online Vision Screening Service (Pharmacy Times)
  • FDA Commissioner Gottlieb Emerges as a Champion for Patient Engagement in 2018; Patient-Centric Guidance Development, Rare Disease Listening Sessions, and the Benefit-Risk Framework (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Diazepam diversion falls 64% as MHRA's POM investigation continues (C+D)
  • Alexion turns to Europe for its next rare disease bet (EP Vantage)
  • NICE no for Roche’s Alecensa (PharmaTimes)
  • Verona CMO to resign (The Pharma Letter)
  • Grifols in 7.5 million euros HIV research agreement (The Pharma Letter-$)
  • JenaValve Technology Continues CE Mark Study Treating Severe Aortic Stenosis with Next-Generation System; Patient Enrollment and Successful Implantations with the Everdur Pericardial Aortic Valve and Coronatix Delivery Catheter (Press)
Asia
  • IHH to counter TPG-Manipal's bid for Fortis (Economic Times)
  • Mitsubishi Tanabe takes Korean company to court as licensing deal turns sour (The Pharma Letter-$)
  • Obesity among Asia-Pacific children a growing health crisis (Japan Today)
 
India
  • Milan Paleja to head Novartis India's pharmaceuticals business (Economic Times)
  • Pharma, IT sectors will face biggest risk from US protectionist moves: Nomura (The Hindu Business Line)
Australia
  • Life insurer AIA Australia wants action big and small on mental health (Financial Review)
  • Pharmaceutical Society of Australia launches new guidelines for My Health Record system (OpenGov)
  • New hospital blamed for sick bottom line (The Australian)
  • Public submissions on scheduling matters referred to the ACMS #22, ACCS #21 and Joint ACMS-ACCS #17 meetings held in November 2017 (TGA)
Canada General Health & Other Interesting Articles
  • We need social workers — not Facebook — to better understand our patients' health (CNBC)
  • Fitbit, UnitedHealth, Empatica heads discuss data privacy challenges for wearables (MobiHealthNews)
  • Costs of 'informal' caregiving for heart disease to reach $128 billion by 2035 (Reuters)
  • PODCAST: 23andMe CEO Anne Wojcicki Is Upending The Consumer Health Game (Forbes)
  • Innovative ways to pay for new antibiotics will help fight superbugs (STAT)
  • What Facebook’s public scrutiny can teach us about artificial intelligence in health care (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.

Need to contact the editor of Regulatory Reconnaissance? Find her on Twitter at @anitamulero or send her an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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