Regulatory Focus™ > News Articles > Regulatory Recon: Drugmakers Pay $67m Over Misleading Doctors on Cancer Drug Survival Data; FDA Seek

Regulatory Recon: Drugmakers Pay $67m Over Misleading Doctors on Cancer Drug Survival Data FDA Seeks More Info on Sarepta DMD Drug (7 June 2016)

Posted 07 June 2016 | By Zachary Brennan 

Regulatory Recon: Drugmakers Pay $67m Over Misleading Doctors on Cancer Drug Survival Data FDA Seeks More Info on Sarepta DMD Drug (7 June 2016)

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

In Focus: US

  • Sarepta soars after the FDA asks for quick do-over on Duchenne drug (FierceBiotech) (TheStreet) (WSJ-$) (SCRIP-$) (PR)
  • US VP Joe Biden calls for greater collaboration to cure cancer (Bloomberg) (Business Insider) (PharmaLetter-$)
  • Drug makers pay $67m for misleading docs about cancer drug survival data (DOJ) (Stat) (Law360-$)
  • Merck’s Patent Win Over Gilead Reversed Over False Testimony (Bloomberg) (Reuters) (Law360-$)
  • FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV Approval (FDA Law Blog)
  • Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk (Focus)
  • FDA staff review questions efficacy of Merck's C. difficile drug (Reuters) (FDA)
  • Action Packages for NDAs and Efficacy Supplements (FDA MAPP)
  • Fairer way to distribute last-ditch drugs gets real-world trial (Nature News)

In Focus: International

  • EU regulator wants more advanced therapies (PharmaPhorum)
  • Global Effort to End AIDS Would Save Millions of Lives (NIH Director’s Blog)
  • Hunting growth, Samsung races to get up to speed on biosimilar drugs (Reuters)
  • Presidents and billionaires drive battle against Africa's deadliest creature (Reuters)
  • Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year (Focus)
  • WHO Prequalification Team: Vector control products (WHO)

ASCO 2016

  • New Studies Rely on the Internet for Help Treating Cancer Patients (WSJ-$)
  • Novartis heads to FDA after lung cancer combo clears pivotal trial (FierceBiotech)
  • Merck and Pfizer executives speak (PharmaLetter)

US: Pharmaceuticals and Biotechnology

  • Gilead’s New CEO Faces Pressures on Hepatitis C Pills (WSJ-$)
  • Mass. is leader in efforts to rein in soaring drug prices (Boston Globe)
  • Studies Try to Estimate MS Drug Prices (MedPage Today)
  • Merck and Fujifilm team up for new $60m microbial plant (BioPharma-Reporter)
  • To halt the spread of Lyme, Nantucket residents consider genetically engineered mice (Stat)
  • Axovant founder, Takeda install ex-Medivation CMO at helm of PhIII-ready startup (FierceBiotech)
  • Industry Concerned About Biosimilarity Statement Recommended in Biosimilar Labeling Guidance (FDANews-$)
  • J&J Won't Have To Avoid New Ads Before Liver Damage Trial (Law360-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Valeant Makes Another Deep Cut to Guidance (WSJ-$) (FirstWord Pharma) (Forbes)
  • Alexion Drug Misses Goal in Neuromuscular Disease Study (WSJ-$)
  • Biogen Misses Primary Endpoint in Top-Line Results from Phase 2 Study of Opicinumab (Anti-LINGO-1) in Multiple Sclerosis (PR) (Reuters) (Investor’s Business Daily) (FierceBiotech) (Xconomy)
  • Bristol-Myers Squibb and MD Anderson Announce New Research Collaboration in Immuno-Oncology Focused on Lung Cancer (PR)
  • Pfizer Announces Positive Top-Line Results from Second Phase 3 Trial of Oral XELJANZ (Tofacitinib Citrate) in Adults with Psoriatic Arthritis (PR)
  • Cytori Announces Enrollment Completion in U.S. Phase III Scleroderma Trial (PR)
  • Adimab and Innovent Expand Partnership for the Discovery of Antibodies and Bispecifics (PR)
  • Cancer-Focused Biotech Syros Files For $69M IPO (Law360-$)
  • Study on new blood test points to personalized depression treatment (Reuters)

Medical Devices

  • FDA Clears a New Latex Condom with the Technology to Ease and Improve the Application of Condoms (PR)
  • Direct-to-Consumer Lab Tests, No Doctor Visit Required (NY Times)
  • Zimmer Biomet to drop $1B on spine-focused LDR Holding (MassDevice)
  • Medical imaging to control costs (MITA)

US: Assorted and Government

  • Part B proceeding, may face House vote (Politico)
  • Senate panel set to approve $2 billion NIH funding increase (Stat)
  • The NIH is abandoning vital clinical research centers. That’s a mistake (Stat)
  • Representative Mike Fitzpatrick Announcing Medical Device and FDA Reform Bills (Legal Reader)
  • Chairman Johnson Demands Answers from FDA on E-Cigarette Regulations (PR)
  • Upton Applauds FDA’s Simplification of Compassionate Use Applications (PR) (Focus)
  • Consultation on Development of Small Molecules, Biologics and Imaging Products Intended for Cancer Patients (NCI)
  • Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus (CDC)

Upcoming Meetings and Events              


  • Health sector will suffer from Brexit, warns Economist report (PharmaTimes)
  • Father petitions NHS to fund kidney drug for son (PharmaPhorum)
  • AIDS charity gears up to challenge NHS England in court (PharmaTimes)
  • UK launch for first hereditary factor X deficiency treatment (PharmaTimes)
  • Medicine Evaluation Committee (MEDEV) hosted by ESIP (European Social Insurance Platform) (EC)



  • The world is alarmed by the Zika outbreak. No one is paying to deal with it (Stat)
  • Harvard Researchers Develop Quick And Cheap Test For Zika Virus (Tech Times)
  • Canada’s support lags for research on Zika (CMAJ)
  • New research finds low risk of Zika virus at Olympics (Reuters)

General Health and Other Interesting Articles

  • For His Latest Trick, John Oliver Forgives $15 Million in Medical Debt (NY Times)

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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