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Regulatory Recon: US Pays More for Drugs as Lawmakers Take Personal Stake in Biotech, Device Companies (1 December 2015)

Posted 01 December 2015 | By Zachary Brennan 

Regulatory Recon: US Pays More for Drugs as Lawmakers Take Personal Stake in Biotech, Device Companies (1 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Why the U.S. Pays More Than Other Countries for Drugs (WSJ-$)
  • Investments Give Lawmakers Personal Stake in Biotech, Health Care (Stat)
  • Poll: Public Souring on Drug Industry (Stat)
  • Priority Review Voucher Pitfalls (Nature Reviews Drug Discovery-$)
  • Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug (Senate Finance Committee) (Bloomberg)
  • NIH flies above the approps fray (Politico)

In Focus: International

  • Beijing aims to refill medicine chest with 'Made in China' drugs (Reuters)
  • Rise of the Robots: UK Pharma Would Gain from More Automation Investment (InPharma-Technologist)
  • Investment in pharma manufacturing key to driving UK economy (Pharmafile)
  • EU approval for Gilead’s HIV combo Genvoya (Pharmafile)
  • Expert View: Pharmaceutical IP exemption extended for Least Developed Countries: Increased efforts to secure sustainable access to treatment (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Ruling Will Thwart Biosimilar Drug Market (WSJ-$)
  • Genome editing: 7 facts about a revolutionary technology (Nature News)
  • How Drug Manager Express Scripts Is Trying To Evade Martin Shkreli's 5,000% Price Hike (Forbes) (WSJ-$) (Bloomberg)
  • UnitedHealth Unit Favors Sanofi, Regeneron Cholesterol Drug (Bloomberg)
  • Regulators approve the first cancer-killing virus (Nature Reviews Drug Discovery-$)
  • Brent Saunders Softens His View On Research With Jim Cramer On 'Mad Money' (Forbes)
  • New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf (CardioBrief)
  • Over 90% of Industry Thinks Pfizer Will Sell Generics Biz (InPharma-Technologist)
  • Adaptimmune allies with Universal Cells on off-the-shelf immunotherapies (FierceBiotech)

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

  • Repros Receives CRL from FDA (Press)
  • PhaseBio Receives FDA Orphan Drug Designation for Vasomera (PB1046) for the Treatment of Cardiomyopathy Associated With Dystrophinopathies (Press)
  • Janssen seeks US & European approval for Stelara to treat Crohn’s disease (PharmaBiz) (PharmaLetter-$)
  • Positive Phase III results for Astellas and Ironwood’s Japan trial of linaclotide (PharmaLetter-$)
  • FDA Questions Role of Negative Trials in Depression Candidate’s Efficacy (FDANews-$)
  • Nivalis Therapeutics Says First Patient Dosed In Phase 2 Study Of N91115 (RTT News)
  • MPP collaborates with the University of Liverpool to develop HIV nanomedicines (PharmaLetter-$)
  • Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-FIX (Press)

US: Medical Devices

  • IUD use attracts new opposition from anti-abortion groups (Reuters)
  • Arizona inspectors find Theranos lab issues (Arizona Republic)
  • The inside story on wearable electronics (Nature News)
  • Caputron Medical Announces FDA Cleared mindGear Treatment for Depression, Insomnia and Anxiety (Press)
  • Biolitec loses Supreme Court bid to overturn $75m contempt ruling (Mass Device)
  • NinePoint Medical raises $30.7m for NvisionVLE imaging system (Mass Device)
  • Nevro beats Boston Scientific’s patent challenges (Mass Device)
  • Medtronic looks primed to beat analyst forecasts again (TheStreet)

US: Assorted and Government

  • Alaska Senator Plans to Block FDA Commissioner Nominee Over Frankenfish (InsideHealthPolicy-$)
  • Will Congress move to stop women’s health disaster? (Philadelphia Inquirer)
  • Karen Midthun’s retirement (Nature Reviews Drug Discovery-$)
  • J&J Hears Consent Decree Echoes In Litigation From ‘Silent’ Motrin Recall (Tan Sheet-$)
  • Communications Team Turns Over At FDA's Device Center (Gray Sheet-$)
  • The Cosmetic Modernization Amendments of 2015 Seek a Facelift for the Cosmetics Industry (FDA Law Blog)
  • KIND wants the FDA to redefine “healthy” to include salmon, avocados—and its own nut bars (Quartz)

Upcoming Meetings and Events              


  • Advaxis Receives Orphan Drug Designation in the European Union for ADXS-HER2 for the Treatment of Osteosarcoma (Press)
  • New web portal highlights UK strengths in medicines manufacturing (Pharmafile)
  • EMA Explains Steps Firms Should Take To Reduce Risk Of medication errors (SCRIP-$)
  • That Time Europe Air-Dropped Vaccine-Loaded Chicken Heads to Bait Rabid Foxes (Atlantic)
  • St. Jude Launches World's First Upgradeable Chronic Pain Management System in Europe (MDDI)


  • Aurobindo gets approval for osteoporosis drug (Press Trust of India)
  • Jubilant Life Sciences jumps 10% following US FDA approval for paroxetine tablets (PharmaLetter-$)


  • Oramed Inks China Licensing Deal for Oral Insulin Candidate (InPharma-Technologist)
  • Symposium on Drug Administration between China and Czech Republic held in Beijing (CFDA)

Other International

  • MannKind Plans to Build Manufacturing Plant in Himalayas (InPharma-Technologist)
  • Australia’s GBMA says adding biosimilar Inflectra on PBS will lead to savings (PharmaLetter-$)
  • Notifying Changes To Marketed Devices In Singapore Becomes Easier From Dec. 1 (SCRIP-$)

General Health and Other Interesting Articles

  • Human Gene Variants Are More Variable Than We Thought (In the Pipeline)
  • Over-the-Counter Medicines’ Benefits and Dangers (New York Times)
  • New York is the first city in the US to add sodium warnings to menus (Vox)

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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