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Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Insys Founder Kapoor Sentenced to 5.5 Years Over Opioid Kickback Scheme; Roche’s Tecentriq Fa

Recon: Insys Founder Kapoor Sentenced to 5.5 Years Over Opioid Kickback Scheme; Roche’s Tecentriq Fails in Phase III Urothelial Cancer Trial

Posted 24 January 2020 | By Michael Mezher 

Recon: Insys Founder Kapoor Sentenced to 5.5 Years Over Opioid Kickback Scheme; Roche’s Tecentriq Fails in Phase III Urothelial Cancer Trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Epizyme prices rare tissue cancer treatment at $15,500 a month (Endpoints) (FDA) (Press)
  • Insys founder gets 5½ years in jail for his role in fentanyl prescription scheme (STAT) (Reuters) (NYTimes)
  • Broken US System Has Pharma on Edge Even as Stocks Hit Highs (Bloomberg)
  • IPI rule may be too little, too late for Trump (Politico)
  • Drug To Prevent Premature Birth Divides Doctors, Insurers And FDA Experts (NPR)
  • Want to know how contentious drug pricing is in Washington? Check the receipts (STAT)
  • Opioid executive admits to ‘no morals’ ahead of prison term (Financial Times)
  • Ipsen's $1B bet on the ropes after interim phase 3 analysis (Fierce) (Endpoints) (Evaluate) (Press)
  • CDC reports second US case of novel virus spreading in China (STAT) (CNBC)
  • Gilead assessing Ebola drug as possible coronavirus treatment (Reuters)
  • US health officials seek emergency approval to use diagnostic test for new coronavirus (Reuters)
  • Pfizer Announces Launches and Pricing Information for Three US Biosimilars (Big Molecule Watch)
In Focus: International
  • Roche's Tecentriq fails trial in form of urothelial cancer (Reuters) (Endpoints) (Press)
  • Tagrisso hit with NICE rejection for NSCLC (PharmaTimes)
  • What’s Next After 20 Years Of NICE? (Pink Sheet-$)
  • Roche Fined For Anticompetitive Behavior In Romania (Pink Sheet-$)
  • Second firm admits illegal role in agreement for essential drug (CMA)
  • Martina Schüssler-Lenz re-elected as chair of Committee for Advanced Therapies (EMA)
  • Deadly Viruses Aren't Pharma's Top Priority. Why Not? (Bloomberg)
  • China heads into Lunar New Year on shutdown as virus toll hits 26 (Reuters)
  • Work to start on three possible China virus vaccines: epidemic response group (Reuters)
  • Coronavirus Is Spreading, but W.H.O. Says It’s Not a Global Emergency (NYTimes) (Reuters)
Pharmaceuticals & Biotechnology
  • PwC report sees pharma-biotech deals 'to be extremely active in 2020' (Fierce)
  • 2019 a 'transformative year' for pharma M&A. Is that a good thing? (Endpoints)
  • Pharma Industry Broadens Its Approach To Expanded Access (Pink Sheet-$)
  • Biosimilar Market Updates: Canada, US, China (Big Molecule Watch)
  • Sanofi Completes Acquisition of Synthorx, Inc. (Press)
  • Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (FDA)
  • Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability; Extension of Comment Period (FDA)
  • 23andMe lays off 100 people as DNA test sales decline, CEO says she was ‘surprised’ to see market turn (CNBC)
  • Trifecta of sickle cell disease therapies extend life expectancy, but are not cost-effective — ICER (Endpoints)
  • Pharma has a chance to rewrite specialty care marketing playbook in 2020: expert (Fierce)
  • Why Pharmacies Are About To Be Hit Hard By Disruption (Forbes)
  • Deerfield vaults to the top of cell and gene therapy CDMO game with $1.1B facility at Philadelphia's newest biopharma hub (Endpoints)
  • Low-dose aspirin may reduce preterm birth risk among first-time mothers (NIH)
  • Kura co-founder heads to Asian multi-national as biotech eyes the goal posts for lead drug (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Lipidor Announces Positive Topline Results of AKP01 Phase III Clinical Study Using Calcipotriol Spray Against Psoriasis (Press)
  • Exelixis Announces Results for Combination of Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Hepatocellular Carcinoma (Press)
Medical Devices
  • Moody's predicts cardiology tech to outpace rest of medical devices, driven by TAVR (MedtechDive)
  • Intuitive eyes new surgery types as competitive pressure looms (MedtechDive)
  • Smith & Nephew acquires Tusker Medical (MassDevice)
  • FDA grants Medtronic an IDE to study new tech for ablating heart tissue (MassDevice)
  • Myriad Genetics Seeks Supplemental Approval of HRD Test as CDx for GSK Ovarian Cancer Drug (Precision Oncology News)
US: Assorted & Government
  • General Causation Experts Excluded In Viagra/Cialis MDL (Drug & Device Law)
  • Trump administration threatens to cut health funding for California over abortion insurance law (The Hill)
  • Opioid Use Disorder: Barriers to Medicaid Beneficiaries' Access to Treatment Medications (GAO)
  • Bayer faces fourth U.S. Roundup cancer trial in Monsanto's hometown (Reuters)
Upcoming Meetings & Events Europe
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020 (EMA)
  • EU Parallel Trade: The ‘Most Effective Savings Tool Available’ (Pink Sheet-$)
  • Five Australian innovators of therapeutic goods (TGA)
Coronavirus Outbreak
  • Parties unite over Taiwan's exclusion from WHO anti-virus planning (Reuters)
  • China’s coronavirus more contagious than SARS but less severe, says ex-FDA chief Scott Gottlieb (CNBC)
  • Possible coronavirus case at a Tennessee university as death toll rises in China (Charlotte Observer)
  • China's Wuhan gets two billion yuan loan to help with fighting virus (Reuters)
  • Ten cities in China's Hubei province suspend some public transportation (Reuters)
  • Many in China Wear Them, but Do Masks Block Coronavirus? (NYTimes)
  • China allocates one billion yuan to Hubei province to fight virus outbreak (Reuters)
  • US senators to get government briefing on coronavirus: aide (Reuters)
  • Texas Student May Have Wuhan Coronavirus, as Dozens in US Are Monitored (NYTimes)
  • Coronavirus risk to British public remains low: health minister (Reuters)
  • Thailand confirms fifth case of new coronavirus (Reuters)
  • Nepal confirms first case of new coronavirus (Reuters)
  • South Korea confirms second case of Chinese coronavirus (Reuters)
  • Japan confirms second case of Wuhan virus: health ministry (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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