Regulatory Recon: FDA Restricts Foreign Scientist Hirings Trump Blasts Merck CEO for Quitting Council (14 August 2017)

Posted 14 August 2017 | By Michael Mezher 

Regulatory Recon: FDA Restricts Foreign Scientist Hirings Trump Blasts Merck CEO for Quitting Council (14 August 2017)

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

In Focus: US

  • FDA puts new restrictions on hiring of foreign scientists, documents show (STAT)
  • A Cancer Conundrum: Too Many Drug Trials, Too Few Patients (NYTimes)
  • Merck CEO Quits Trump Advisory Council in 'Stand Against Intolerance and Extremism' (WSJ) (Endpoints) (STAT) (Forbes) (Financial Times) (The Street)
  • FDA Considers WHO Scheduling Change for 17 Drug Substances (Focus)
  • A Supreme Court pharma case deals consumers a big loss (STAT)
  • With deadlines looming, pharma companies look to tighten drug security (STAT)
  • Drug industry faces 'tidal wave' of litigation over opioid crisis (Financial Times) (The Street)
  • US blockchain company in tie-up on medical artificial intelligence (Reuters)
  • FDA Lifts Hold on CEL-SCI Phase III Head & Neck Cancer Trial (The Street) (Endpoints) (Press)
  • Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank (KHN)
  • Novartis partner Ophthotech says wet-AMD drug Fovista goes 0-for-3 in PhIII (Endpoints) (Fierce) (Press)
  • Gap between Trump, advisers widens on health care (Politico)
  • 'Right to Try' Bill Could Face Slower Action in House (Roll Call)

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In Focus: International                         

  • India aims to revamp health scheme, lower costs after criticism (Reuters)
  • Focused on data and drug development, SoftBank hunts new $1B biotech deals (Endpoints)
  • Mundipharma picks up a PhIII-ready chemo creation in $250M deal (Endpoints) (Fierce)
  • New Research Compares Drug Regulators Around the Globe (Focus)
  • Where have all the generics gone? You won't find many in Mexico (STAT)
  • Billionaire Shanghvi's Sun Pharma Surprises With Loss (Bloomberg) (SCRIP-$)
  • Korea's Reimbursement Steps Spark Drug Price Cut Concerns (Pink Sheet-$)
  • Pfizer Alum's China Startup Is Said to Select Banks for IPO (Bloomberg)
  • China's Fosun, Shanghai Pharma say bid for stake in U.S. drug maker Arbor (CNBC) (Bloomberg)
  • NICE expands Merck KGaA's Erbitux reach (PMLive)
  • NICE knocks back advanced kidney cancer drug duo (Pharmafile) (PharmaTimes)
  • Time running out on new Stada takeover bid (PMLive)
  • Takeda strikes partnership to develop single-drug cancer combo immunotherapies (Pharmafile)
  • Pooled Purchasing Is Poor Answer To Latin American Drug Pricing Worries, Says Industry (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Zynerba shares crushed (again) as back-to-back flops leave lead drug under a cloud (Endpoints)
  • 'The stigma is more in my own mind': men on using Viagra (The Guardian)
  • I changed my patient's blood pressure medications. Why weren't they working? (Washington Post)
  • Cancer Survival Takes a Hit with Alternative Medicine (Medpage)
  • Has the Brent Saunders price-hike limit become a de facto pharma rule? (Fierce)
  • J&J beefs up neuro pipeline, bags a new depression drug from Cerecor in $45M deal (Endpoints)
  • In a rare misfire, Regeneron scraps its RSV drug after a PhIII failure (Endpoints)
  • Dr Gottlieb's quarterly progress report: more FDA staff and more generics (PharmaLetter-$)
  • Cancer survivors may seek unneeded tests for reassurance (Reuters)
  • OTC Monograph User Fees Still On The Table, But Not In Legislation (Pink Sheet-$)
  • Novartis veteran David Epstein takes leadership role at Rubius (Endpoints)
  • James Mullen backs Vicarius' $22M series A to equip ex-Biogen, Elan team to offer US biotechs a route to Europe (Fierce)
  • What To Know About New FDA Informed Consent Guidance (Law360-$)
  • Will 'Right To Try' Bill Actually Help Anyone? (Medpagae) (FDANews-$)
  • Hi-Tech Pharmacal Short on Sterility, FDA Says (FDANews-$)
  • ICER to evaluate emicizumab for hemophilia A (PharmaLetter-$)
  • DSCSA Verification and Suspect Product (RxTrace)
  • Aka-what? Fanapt maker Vanda puts antipsychotic side effect front-and-center in TV awareness ads (Fierce)
  • FDA's Proposes Biomass Method to Obtain Animal Antimicrobial Sales and Distribution Data based on Animal Species and Weight (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • H3 Biomedicine Granted Orphan Drug Designation of H3B-8800 for Treatment of Acute Myelogenous Leukemia and Chronic Myelomonocytic Leukemia (Press)
  • Anthera Pharmaceuticals Announces RESULT Phase 3 Clinical Study of Sollpura will be Included in the European Cystic Fibrosis Clinical Trial Network (Press)

Medical Devices

  • What FDA's Digital Health Innovation Plan Means for Digital Diagnostics (MDDI)
  • Novel nanotech enables earlier diagnosis, treatment of Zika virus (Drug Delivery)
  • Senseonics keeps busy with Europe launch, Roche partnerships while FDA wait continues (MobiHealthNews)
  • You Can Order a Dozen STD Tests Online — But Should You? (NPR)
  • William Demant may make over-the-counter hearing aids if US demand develops (Reuters)
  • MannKind plots trial pairing inhaled insulin Afrezza with One Drop's digital diabetes manager (Fierce)
  • Renovis wins FDA nod for Tesera lumbar interbody fusion systems (MassDevice)
  • Abbott extends Alere tender offer (MassDevice)
  • Medtronic launches DAPT study for Resolute Onyx DES (MassDevice)
  • Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems (Press)

US: Assorted & Government

  • What Could Happen If Trump Formally Declares Opioids A National Emergency (NPR)
  • It's Not Enough For Trump To Declare Opioid Epidemic A National Emergency (Forbes)
  • Health Insurers Get More Time to Calculate Increases for 2018 (NYTimes)
  • Anthem to exit Obamacare market in Virginia next year (Reuters)
  • Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute (FDA Law Blog)
  • Johnson & Johnson expected to keep battling talc claims despite losses: expert (Fierce)

Upcoming Meetings & Events


  • Adopted Guideline: Guideline on manufacture of the finished dosage form (EMA)
  • Switching, Substitution & Quotas: Irish Govt Wants Views On Boosting Biosimilars (Pink Sheet-$)
  • Reprocell grows cell and tissue-based services in Scotland (BioPharmaReporter)
  • 'Hugely disturbing' rise in UK children with type 2 diabetes, report finds (Pharmafile) (PharmaTimes)
  • Marijuana products sending more French kids to ERs (Reuters)
  • Tackling GDPR compliance before time runs out (McKiney)



  • Cipla Signals US Launch Momentum, Commodity-Like Price Cycle (SCRIP-$)
  • Divi's Lab gets green nod for Rs 100-cr modernisation project (Economic Times)
  • Alkem Labs to tap domestic, international markets for growth (Economic Times)
  • DoP directs NPPA to re-fix ceiling price of N-acetylcyseine 200mg sachet (PharmaBiz)
  • BIRAC invites research proposals from start-up biotech cos under BIG scheme (PharmaBiz)
  • IPC launches training of institutions to start intensive monitoring of ADRs in specific drugs (PharmaBiz)
  • Pharma equipment manufacturing industry making ground in India to substitute imports (PharmaBiz)
  • Natco gets USFDA nod to market renal disease drug (Economic Times)


  • Updates to the list of designated orphan drugs (TGA)
  • Permissible Ingredients Determination: Forecast of updates (TGA)

Other International

  • Cholera count reaches 500 000 in Yemen (WHO) (Reuters)
  • Gates foundation to spend over $300 million in Tanzania in 2017 (Reuters)

General Health & Other Interesting Articles

  • If You Eat an Animal That Ate Drugs, Will It Affect You?  (Gizmodo)
  • Epilepsy Not As Rare As Many Might Think -- And Cases Are Increasing (Forbes)
  • Profile: The Accidental Cancer Giant (Medpage)
  • Fighting HIV/AIDS: Human-Rights Focused Advocacy Is More Critical Than Ever (Health Affairs Blog)
  • IBM Watson Makes a Treatment Plan for Brain Cancer Patient in 10 Minutes; Doctors Take 160 Hours (IEEE Spectrum)

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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