Regulatory Recon: United Therapeutics Settles US Kickback Probe for $210M Roche Wins US, EU Cancer Approvals (21 December 2017)

Posted 21 December 2017 | By Michael Mezher 

Regulatory Recon: United Therapeutics Settles US Kickback Probe for $210M Roche Wins US, EU Cancer Approvals (21 December 2017)

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

In Focus: US

  • United Therapeutics to pay $210 million to resolve US kickback probe (Reuters) (STAT) (DoJ)
  • Fearful of a Shutdown, Congress Inches Toward Stopgap Spending Bill (NYTimes)
  • Will Trump Listen to AdvaMed's 11th Hour Tax Plea? (MDDI) (AdvaMed)
  • CHIP gets some funding, but will Democrats go along? (Politico)
  • Those high-priced CAR-T therapies are actually cost effective (STAT) (Endpoints)
  • Life expectancy in the US is falling — and drug overdose deaths are soaring (STAT) (NPR)
  • Arthritis drugs show how US drug prices defy economics (NBC)
  • A Prescription for Reducing Wasted Health Care Spending (ProPublica)
  • 2018's best-sellers? AbbVie's Humira, obviously, but newcomers are on their way (Fierce)
  • Gene therapy may be worth $1m (Financial Times 1, 2)
  • FDA approves new diabetes drug from Merck and Pfizer (Reuters) (Endpoints)
  • Canada's Aeterna gets FDA approval for growth hormone deficiency test (Reuters) (Press)
  • FDA to fast track Mesoblast's cell therapy for heart failure (Reuters)
  • FDA Approves Adjuvant Nivolumab for Melanoma (OncLive) (Press)
  • Considering Direct-to-Consumer Genetic Testing? Spit with Caution (Harvard Bill of Health)
  • Biosimilar Sponsors Seek Statistical Flexibility When Reference Products Change (Pink Sheet-$)
  • Illinois AG sues Baxter for polluting lake (Drug Delivery) (Law360-$)
  • FDA rejects Santen's intravitreal uveitis therapy (Drug Delivery) (Press)
  • Biogen, Eisai Alzheimer's Drug Fails First Test But Study Continues (Xconomy) (Fierce) (Endpoints)
  • What This Computer Needs Is a Physician: Humanism and Artificial Intelligence (JAMA)

In Focus: International

  • Roche scores cancer drug approvals in Europe and US (Reuters) (Press)
  • Absent From Cancer Drugs, Glaxo Signals a Revival With New Hire (Bloomberg)
  • End of year message from EMA's Executive Director (EMA)
  • European Medicines Agency closed 22 December 2017 to 2 January 2018 (EMA)
  • NHS England consults on curbing OTC prescriptions (PharmaTimes)
  • NICE proposes restricting MS therapies (PharmaTimes)
  • The rare disease climate in Europe (Pharmafile)
  • BMS Nabs MHRA Early Access Designation for Opdivo in Gastric, Gastroesophageal Junction  Cancer (MHRA)
  • Orphan medicines in the EU – leaving no-one behind (EMA)
  • JSR Acquiring Chinese CRO Crown (BioCentury)
  • vTv Therapeutics out-licenses diabetes program in China, Pacific Rim (PharmaLetter-$)
  • Takeda's Dengue Vaccine Candidate Aims To Avoid Dengvaxia Problems (Pink Sheet-$)
  • Revised EU Guide Addresses Ambiguities In Reporting of Safety Info From Trials (Pink Sheet-$)
  • WHO delivers 70 tons of life-saving medicines and supplies to Sana'a (WHO)
  • Plague in Madagascar — A Tragic Opportunity for Improving Public Health (NEJM)
  • Suspected cholera cases in Yemen hit 1 million: ICRC (Reuters)

Pharmaceuticals & Biotechnology

  • FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership (Health Policy & Law) (Part 2)
  • Scientists Use Gene Editing To Prevent A Form Of Deafness In Mice (NPR)
  • For better quality of life, older cancer patients need more than just medicine (Reuters)
  • Are Researchers Who Work With Industry Always Evil? (Medpage)
  • Soligenix Identifies Biomarkers for Ricin Toxin Vaccine Testing under the FDA Animal Rule (Press)
  • What's ahead for generics? More pricing woes, analysts say, but execs see better times (Fierce)
  • Warning to I-O drugmakers: If investors were hyperfocused on data this year, just wait till 2018 (Fierce)
  • 5 Amazing Medical Breakthroughs That Deserve A Toast This Christmas (Forbes)
  • 2017: The dawning of cell and gene therapies (BioPharmaReporter)
  • 2017: The year the US opened the biosimilar floodgates (BioPharmaReporter)
  • Amendment to "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products Guidance for Industry (FDA)
  • Tissue engineering – a fast-growing field for advancement of medicine (PharmaLetter-$)
  • Peter Thiel-backed startup fund taps Science Exchange's outsourcing platform (Fierce)
  • Finance Watch: The Year's Biggest IPO And A Post-ASH Offering Splash (SCRIP-$)
  • A little boy's fragile skin and stunted growth spur an eight-year search for answers (STAT)
  • CRO woes: are companies better off using in-house resources? (PharmaLetter-$)
  • Opportunity for Pfizer and Valneva, as Sanofi opts out of C. difficile vaccine program (PharmaLetter-$)
  • Celgene, GV-backed FLX gets off $60M round, kickstarts I-O trials (Fierce)
  • NME Approvals Nearly Doubled In 2017 (BioCentury)
  • A year in review: The most popular medical research of 2017 (MNT)
  • Google backs a $60M transition round for FLX's switch to a CCR4 strategy (Endpoints)
  • Backed by Henri Termeer estate, Aura raises $30M for work to prevent blindness in eye cancer patients (Endpoints)
  • FDA Clarifies Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Accepts New Drug Application For Seysara™ (Sarecycline) For The Treatment Of Moderate To Severe Acne (Press)
  • AIVITA Biomedical Announces First Patient Enrolled in Phase II Clinical Trial for Late-Stage Ovarian Cancer (Press)
  • Adaptive Phase II Study of BAN2401 in Early Alzheimer's Disease Continues toward 18-Month Endpoint (Press)
  • Ironwood Pharmaceuticals Initiates Phase II Clinical Trial of sGC Stimulator IW-1701 in Patients with Sickle Cell Disease (Press)
  • Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease (Press)

Medical Devices

  • 4 Things Medtech Should Be Prepared for in 2018 (MDDI)
  • Beetle Penises May Hold Clues For Better Medical Devices (NPR)
  • Gynesonics Announces Submission of FDA 510k for Incision-Free Treatment of Symptomatic Uterine Fibroids (Press)
  • Pentagon re-ups $14m General Electric contract for patient monitoring systems (MassDevice)
  • BioCorp's smart cap wins CE Mark for insulin pen (Drug Delivery)

US: Assorted & Government

  • 50 State AGs Announce $13.5M Settlement With Boehringer Ingelheim Over Deceptive and Off-Label Promotion (Press)
  • Trump Falsely Claims to Have 'Repealed Obamacare' (NYTimes)
  • Republican US tax bill deals biggest blow yet to Obamacare (Reuters)
  • Growing number of US hospitals can't treat kids (Reuters)
  • As Overdoses Mount, Cities and Counties Rush to Sue Opioid Makers (NYTimes)
  • The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President's Commission on Combating Drug Addiction Ignored Promising Medical Treatments (Harvard Bill of Health)
  • The Lows − Mourning the Worst Prescription Drug/Medical Device Decisions of 2017 (Drug & Device Law)
  • Diagnosing Patent Subject Matter Eligibility (Patent Docs)
  • Feds To Retry Ex-Biotech Exec After Mistrial In Fraud Case (Law360-$)
  • Johnson & Johnson unit sues ex-rep over defection to Zimmer Biomet (MassDevice)
  • HHS Finds 885 Drugs Misclassified Under Medicaid, $1.3 Billion in Missing Rebates (FDANews-$)

Upcoming Meetings & Events


  • EudraVigilance System v.1.3 Release Notes  (EMA)
  • Dossier requirements for NAPs (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (EMA)
  • New Finnish-South Korean pact to develop controlled release oncology products (PharmaLetter)
  • Lactalis extends baby product recall after finding contamination source (Reuters)


  • Sun Pharma recalls two batches of diabetic drug from US market (Economic Times)
  • Lawmaker writes to PM Narendra Modi urging price caps on 20 medical devices (Economic Times)



  • Presentations: Codeine up-scheduling workshop, Brisbane, 13 December 2017 (TGA)
  • Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018 (TGA)

Other International

  • Mexico to legalize marijuana-based product sales next year (Reuters)
  • Food security in Middle East, North Africa deteriorating, says UN agency (Reuters)

General Health

  • Living With Cancer: Immortality at Midnight (NYTimes)

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 him on Twitter at @Michael_Mezher or send him an email at

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

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