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Recon: Shkreli Sentenced to 7 Years

Posted 09 March 2018 | By Ana Mulero 

Recon: Shkreli Sentenced to 7 Years

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

In Focus: US
  • Despite FDA concerns, Pfizer's Xeljanz wins unanimous AdComm backing in ulcerative colitis (Fierce) (Reuters) (PharmaTimes) (MedPage Today)
  • Shkreli sentenced to 7 years on felony fraud (WSJ)
  • Judge orders 1,200 Xarelto liability cases to be prepped for trials (Fierce)
  • Sanofi Clears a Hurdle in Bribery Probe (WSJ) (Fierce)
  • Amazon’s pharmacy hires hint of ambitions to upend a $360 billion market (STAT-$) (Becker’s Hospital Review)
  • Flu vaccine grown without eggs provided measurably better protection this season, FDA says (STAT) (Focus) (CNN)
  • Doctor in a Opioid Kickback Scheme Due to Be Sentenced (AP News) (Reuters)
  • Trump officials tell Idaho it can’t dump Obamacare (Politico) (Reuters) (CNN) (Bloomberg)
  • FDA Approves 2 Cinacalcet Hydrochloride Generics for HPT Market Competition (MD Magazine) (Focus)
In Focus: International Pharmaceuticals & Biotechnology
  • Biotech boss Jackie Hunter takes aim at male tech culture (Financial Times)
  • Seattle Genetics Completes Tender Offer for All Shares of Cascadian Therapeutics (Press)
  • Enabling Novel Treatments for Nervous System Disorders by Improving Methods for Traversing the Blood—Brain Barrier: Proceedings of a Workshop (National Academy of Sciences)
  • Genentech Fights For $5.8M In ‘Exceptional' IP Attys Fees (Law360-$)
  • ICER Weekly View 03-09-18 (ICER)
  • AI-driven drug discovery startup Atomwise raises $45M series A (Fierce)
  • Johnson & Johnson's $15B in 2017 discounts lead to negative price change, but are consumers benefiting? (Fierce)
  • MSKCC’s Maura Dickler to become Eli Lilly’s new late-stage cancer R&D lead (Fierce) (Press)
  • Nimbus founding CSO Rosana Kapeller leaves to explore exec role; AI startup BioXcel pockets $60M from IPO (Endpoints News) (Fierce) (Press)
  • Senators heap abuse on Allergan’s attempt at an end run around patent reviews, offer bill to stop ‘sham’ (Endpoints News)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Xeljanz's UC Indication On Track With Higher Doses After Unanimous Advisory Committee Votes (Pink Sheet-$)
  • Synthetic polymers could be the silver bullet for multidrug-resistant superbugs (Fierce)
  • AM-Pharma still on track with sepsis drug despite mixed phase 2 readout (Fierce) (Press)
  • MyoKardia steps closer to the launch of a groundbreaking heart trial after finding its low-dose starting point (Endpoints News) (Fierce)
  • Voyager’s gene therapy for Parkinson’s shows promise in early data from small Phase Ib trial (Endpoints News) (Press)
  • Beyond Flatiron: The Rising Power Of Oncology Clinical Data Companies (Forbes)
  • Trial And Error, Or The Problem Of Clinical Trial Data Exclusivity (Above The Law)
  • Why Not Do A Randomized Trial Of Precision Oncology? (Forbes)
  • Servier and Pfizer Announce Results of UCART19 First-in-Human Trials to Be Presented at the 44th EBMT (European Society for Blood and Marrow Transplantation) Annual Meeting (Press)
  • FDA sets path for stem cell therapies (CNN)
  • TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR (Press)
  • US cancer network recommending expensive drugs based on weak evidence, study finds (The Guardian)
Medical Devices
  • Xeris hauls $55M in new funding to bring glucagon pen to market (Endpoints News) (Press)
  • Two Women Are Building A Pregnancy Test-Like Device To Spot Cervical Cancer (Forbes)
  • Clinical systems tech companies unwrap new applications at HIMSS18 (Healthcare IT News)
  • J&J CIO touches on FDA pre-cert pilot program, artificial intelligence and innovation (MedCity News)
  • Medtronic’s MiniMed 670G insulin delivery system gave me peace of mind (MedCity News)
  • Somatix Takes The Activity Tracker From An Athletic Option To A Clinical Imperative (Forbes)
  • Polyganics liver and pancreas sealant wins FDA breakthrough designation (MassDevice) (Press)
  • WaveForm Technologies Receives Favorable Decision on Critical Glucose Monitoring Patents (Press)
  • LivaNova finalizes details in $190m CRM sale to MicroPort (MassDevice)
  • Valencia Tech wins FDA nod for eCoin neurostim overactive bladder trial (MassDevice) (Press)
  • Alphatec raises $50m, acquires SafeOp Surgical (MassDevice)
  • Inovalon to buy ABILITY for $1.2 billion (Healthcare IT News)
  • Enhatch Develops Fit2Kit Patient-Driven Technology Platform For Medical Device Manufacturers And Orthopedic Surgeons (Press)
  • GE Additive launches Orthopaedic Validation Consultancy for metal AM medical devices (Metal Additive Manufacturing magazine)
  • PrescribeWellness Partners With Venebio to Help Local Pharmacies Address the Opioid Epidemic (Press)
  •  Magellan Expands Digital Innovation Platform and Strategy (Press)
US: Assorted & Government
  • Health Officials Assail ‘Pricing Schemes’ That Gouge Patients (NYT)
  • Merck C.E.O. Ken Frazier on Death Row Cases and the Corporate Soul (NYT)
  • Senator Murray Emphasizes Need for Federal Government to Support State Innovation to Address Opioid Crisis (HELP Committee)
  • The Martin Shkreli saga ends today, but the issue he raised on drug pricing seems immortal (Endpoints News)
  • Pharmalittle: J&J says average prices paid for its drugs declined; feds will use false claims to crack down on opioid abuse (STAT-$)
  • Shkreli Lawyer Says He Alternately Wants to Punch and Hug Client (Bloomberg)
  • Cigna to Draw Antitrust Scrutiny Amid Health-Care Deal Wave (Bloomberg)
  • With Express Scripts Debt, Cigna Needs Anthem Break-Up Money (Forbes)
  • Human API and CMS collaborate to help Medicare patients share claims data in new chapter for Blue Button (MedCity News)
  • NQF Issues Critical Guidance to Support Safer Opioid Prescribing (NQF)
Upcoming Meetings & Events Europe
  • MHRA Freedom of Information Act (FOIA) request Disclosure Log index (MHRA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018 (EMA)
  • WuXi Biologics is producing a newly approved HIV med in the first Chinese biologics plant approved by the FDA (Fierce) (Press)
  • Teleflex settles spat with Chinese distributor (MassDevice)
  • Microsoft, Apollo Hospitals to employ AI for early detection of cardiac diseases (Healthcare IT News)
  • Govt committed to making healthcare services affordable: MoS Health (Times of India)
  • Why Potentially Dodgy Diabetes Drugs Dominate in India (NPR)
  • Pulsus opens healthcare informatics, pharmacovigilance facility in Chennai (Times of India)
  • Section 23 instruments (TGA)
  • Recall - potential risk of harm for children who access the button battery (TGA)
  • Shares in Australian pharma Immuron are going nuts (Business Insider)
  • Elto Pharma Receives Notice of Allowance in Australia for Patent Covering Eltoprazine in the Treatment of Parkinson's Levodopa-induced Dyskinesia (Press)
  • 'Unprecedented': Health costs the Australian economy $40 billion per quarter (The Sydney Morning Herald)
  • Nation losing the battle to keep kids safe (The Australian)
  • TearLab loses Canadian patent spat with i-Med Pharma (MassDevice)
  • Health Canada Warns Women Not To Take Chipped Birth Control Pills (HuffPost Canada)
  • More chipped birth control pills found in Apotex's Alysena products (CBC)
General Health & Other Interesting Articles
  • Beware this insurer’s sneak attack on emergency care coverage (STAT)
  • For diabetics, a high-fiber diet feeds gut microbes, lowering blood sugar (STAT)
  • America Is Giving Away the $30 Billion Medical Marijuana Industry (Bloomberg)
  • Survey: Health app adoption has tripled since 2014 (mobihealthnews)
  • How NASA's telemedicine doctors keep International Space Station astronauts healthy (Healthcare IT News)
  • Fewer heart attack patients die when top cardiologists are away at conferences, study finds (The Telegraph)
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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