The RAPS store will be under maintenance Saturday, 29 February between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

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 $1.1B facility at Philadelphia's newest biopharma hub (Endpoints)
  • Low-dose aspirin may reduce preterm birth risk among first-time mothers (NIH)
  • Kura co-founder heads to Asian multi-national as biotech eyes the goal posts for lead drug (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Lipidor Announces Positive Topline Results of AKP01 Phase III Clinical Study Using Calcipotriol Spray Against Psoriasis (Press)
  • Exelixis Announces Results for Combination of Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Hepatocellular Carcinoma (Press)
Medical Devices
  • Moody's predicts cardiology tech to outpace rest of medical devices, driven by TAVR (MedtechDive)
  • Intuitive eyes new surgery types as competitive pressure looms (MedtechDive)
  • Smith & Nephew acquires Tusker Medical (MassDevice)
  • FDA grants Medtronic an IDE to study new tech for ablating heart tissue (MassDevice)
  • Myriad Genetics Seeks Supplemental Approval of HRD Test as CDx for GSK Ovarian Cancer Drug (Precision Oncology News)
US: Assorted & Government
  • General Causation Experts Excluded In Viagra/Cialis MDL (Drug & Device Law)
  • Trump administration threatens to cut health funding for California over abortion insurance law (The Hill)
  • Opioid Use Disorder: Barriers to Medicaid Beneficiaries' Access to Treatment Medications (GAO)
  • Bayer faces fourth U.S. Roundup cancer trial in Monsanto's hometown (Reuters)
Upcoming Meetings & Events Europe
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020 (EMA)
  • EU Parallel Trade: The ‘Most Effective Savings Tool Available’ (Pink Sheet-$)
Australia
  • 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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe