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Recon: Big Tech Firms Look to Disrupt Health Care

Posted 14 March 2018 | By Ana Mulero 

Recon: Big Tech Firms Look to Disrupt Health Care

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

In Focus: US In Focus: International
  • Bolivian women weave devices to patch holes in hearts (Reuters)
  • As Shingrix rivalry looms in the U.S., Merck's Zostavax yields share in Korea to SK’s Skyzoster (Fierce)
  • Multinationals cause drug shortages – again (Korea Biomedical Review)
  • 2017 a record breaking year for biosimilars approvals (The Pharma Letter-$)
  • Cabinet OKs India-Iran MoU on cooperation in health and medicine (webIndia)
Pharmaceuticals & Biotechnology
  • Lousy year for shareholders, but Allergan CEO Brent Saunders sprints past Gorsky, Gonzalez with $32M pay package (Endpoints News)
  • Biotech tries to break bread with Silicon Valley’s disruptors. It’s awkward (STAT)
  • Former Rep. Henry Waxman says lawmakers ‘derelict’ if they don’t address drug prices (STAT)
  • Innovative Solutions to Address Rising Drug Prices (CVS Health)
  • PierianDx Announces Partnership with Cancer Genetics to Provide Comprehensive Precision Oncology Testing and Workflow Solution (Press)
  • Online ‘quality assured’ API trading platform to launch this year (in-PharmaTechnologist)
  • AbbVie blockbuster leads 2017 top drug sales; Roche cancer meds follow closely (S&P Global)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Tracking a successful DLBCL assault in Phase II, MorphoSys sets out to seize quick OK for MOR208 (Endpoints News)
  • Standard Textile product could save hospitals millions, study finds (Cincinnati Business Courier)
  • BioTime Submits CE Mark Application for European Approval of Renevia (Press)
  • In The War Against High Drug Prices, Some Patients Are Collateral Damage (Forbes)
  • NIH scientists search for the clocks behind aging brain disorders (NIH)
  • FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) in Adult Patients with Sialorrhea (Press)
  • Stem cell centers on the rise, claim high efficacy for treatment of knee osteoarthritis despite lack of evidence (Press)
Medical Devices
  • Exactech wins FDA nod for Equinoxe stemless shoulder (MassDevice) (Press)
  • Judge rips into Abbott’s diabetes test strip supplier over discovery fraud (Drug Delivery Business News)
  • With these patents, Apple could win the next major platform war (Quartz)
  • AliveCor smartphone add-on, algorithm discern high potassium levels in ECG data (Fierce)
  • Qiagen pays $40M to work with Natera on prenatal screening tests (Fierce)
  • Zoll LifeVest fails to cut sudden deaths in heart attack trial (Fierce)
  • At-home genetic testing may be convenient, but it isn’t complete (STAT)
  • Calif. Genetic Test Co. Pays $11M To Resolve FCA Claims (Law360-$)
  • FDA Warning Wire: Online Eye Exam Gets Agency Side-Eye (Law360-$) (Focus)
  • UPenn Study Provides Insight into How Consumers Use Wearable Devices in Relation to Health (India-West)
  • Study adds to understanding about utility of ultra-sensitive cardiac troponin measurement in diagnosing and predicting cardiovascular syndromes (Press)
  • FDA Clears CereMetrix’s Neuroimaging Analytics and Clinical Workflow Platform (Press)
  • United Health Products Receives CE Mark Approval for HemoStyp (Press)
  • UTHealth/Memorial Hermann conduct first sinus surgery in US with augmented reality technology (Press)
  • Fitbits help track inpatient activity after abdominal cancer surgery (Healio)
  • Avinger Provides Update on U.S. Intellectual Property Portfolio: Three New Patents Allowed or Issued for Proprietary CTO Crossing Devices (Press)
  • Ciox Health Teams Up with NextGen Healthcare to Streamline Record Retrievals (Press)
  • Certara Launches Industry-first Quantitative Systems Pharmacology (QSP) Consortium on Immuno-oncology with Leading Pharma Company Members (Press)
  • Mardil Medical Announces First Human Implants of the VenTouch Triad Targeted Ventricular Reshaping System (Press)
US: Assorted & Government
  • Hospitals missing from gun control debate (Politico)
  • Trump Weighs Firing Veterans Affairs Secretary Shulkin (Bloomberg) (NYT)
  • Uber Wants Labor Dept.'s Health Rule to Consider Gig Workers (Bloomberg)
  • Drug copays sometimes exceed costs (Reuters) (JAMA)
  • Participants In Rogue Herpes Vaccine Research Take Legal Action (KHN)
  • Opioid Bills Would Up Feds' Control Over Quotas, Imports (Law360-$)
  • Will the Supreme Court Take on the False Claims Act Materiality Standard? (FDA Law Blog)
  • GOP Leaders' Bill Could Let Patients Use Medical Marijuana (Forbes)
  • New Law Broadens Chronic Care Through Medicare (Forbes)
  • Patients Overpay For Prescriptions 23% Of The Time, Analysis Shows (KHN)
  • Measuring the Toll of the Opioid Epidemic Is Tougher Than it Seems (ProPublica)
Upcoming Meetings & Events Europe
  • German doctor warns physicians: never again partake in atrocities (Reuters)
  • Digital tech could unlock £22 billion for UK pharma, Accenture claims (The Pharma Letter-$)
  • Could 'Slack For Surgeons' Finally Kill Pagers In The NHS? (Forbes)
  • NHS under ‘intolerable’ pressure – but no new money until autumn (pharmaphorum)
  • No more silo thinking: Reducing Pharmaceuticals in the Environment and AMR (EPHA)
Asia India
  • Indian pharma market growing strongly in 2018 (The Pharma Letter-$)
  • India’s Prime Minister Pledges Massive Push To Fight World’s Top Infectious Killer (HuffPost)
  • India's Andhra Bank shares slide amid fraud probe involving ex-director (Reuters)
Australia
  • Changes to the therapeutic goods advertising framework (TGA) (Focus)
  • This Professor Wrote There Was No Evidence For Using Cannabinoids For Pain. Then He Said The Opposite. (BuzzFeed News)
  • BlackBerry helps to secure and advance medical research in Australia (Healthcare Innovation)
Canada
  • Lobby wrap: New pharma registrations for drug approvals, rare drug policy (iPolitics)
  • Valeant Receives Health Canada Approval of SILIQ (Brodalumab) For Moderate-To-Severe Plaque Psoriasis (Press)
General Health & Other Interesting Articles
  • Loneliness doesn’t drive seniors to see more doctors (Reuters)
  • Another fallout from the Great Recession: Fewer people took their blood pressure and diabetes medications (STAT)
  • Artificial Intelligence In Healthcare: Separating Reality From Hype (Forbes)
  • For Aspiring Doctors With Disabilities, Many Medical Schools Come Up Short (NPR)
  • A startup is pitching a mind-uploading service that is “100 percent fatal” (MIT Technology Review)
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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