Regulatory Recon: UK Chancellor Pledges EU-Level Science Funding After Brexit Congress Keeps FDA From Reviewing Human Germline Modifications (15 August 2016)

Posted 15 August 2016 | By Michael Mezher 

Regulatory Recon: UK Chancellor Pledges EU-Level Science Funding After Brexit Congress Keeps FDA From Reviewing Human Germline Modifications (15 August 2016)

Welcome to Regulatory Reconnaissance, your adaily 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

  • The Race For A Zika Vaccine ( The New Yorker)
  • Endo to withdraw FDA application for abuse-deterrent labelling on opioid drug ( Pharmafile) ( PharmaTimes)
  • Should Gilead Split in Two? ( The Street, 2)
  • Whistleblower case contends surgical device maker misled FDA — and patients paid the price ( STAT)
  • The FDA is prohibited from going germline ( Science Mag)
  • A genome-editing strategy to treat β-hemoglobinopathies that recapitulates a mutation associated with a benign genetic condition (Nature)
  • New Federal Trade Secret Act and Its Impact on Life Sciences ( Genomics Law Report)
  • Why the US decision to expand marijuana supply for research matters ( Nature)
  • FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors ( Focus) ( BioCentury) ( MedPage)
  • Delaware court backs UCB drug patent, shares jump ( Reuters)
  • Cost, Not Choice, Is Top Concern of Health Insurance Customers ( NYTimes)
  • Schizophrenia, Autism Risk Gene Trajectories Point to Shared Causes ( NIH)
  • Orphan Drug Utilization and Price Changes (2012 – 2014) ( AHIP)
  • Death by Medical Error: Adding Context to Scary Numbers ( NYTimes)
  • Working to get its pain R&D strategy back on track, AcelRx steps closer to an FDA pitch ( Endpoints) ( Fierce)
  • Drugmakers Hit With Suit Over Nerve-Damaging Antibiotic ( Law360-$)
  • Alexander Condemns Senate Democrats For Blocking $1.1 Billion in Zika Aid ( Senate HELP)
  • Where Trump And Clinton Stand On Health Care And Medicare ( Forbes)
  • Medtronic Seeks To Nix State-Law Claims In FCA Suit ( Law360-$)
  • U.S. Declares Zika an Emergency in Puerto Rico ( NYTimes) ( Reuters)
  • Most seniors won't abuse opioids after surgery ( Reuters)
  • What should healthcare do about its cybersecurity problem? ( MedCityNews)

In Focus: International

  • UK's Chancellor guarantees EU-level funding beyond date of 'Brexit' ( PharmaLetter-$) ( Financial Times) ( BBC)
  • WHO will vaccinate in five African nations after polio outbreak ( Washington Post) ( NYTimes) ( Reuters)
  • Hard Times in Venezuela Breed Malaria as Desperate Flock to Mines ( NYTimes)
  • India Prevenar 13 Patent Challenge Closely Watched As Test Case ( Pink Sheet-$)
  • MHLW Study Group to Look at Measures to Popularize Biosimilars, Increase Efficiency in Development and Manufacturing ( PharmaJapan-$)
  • Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority ( Focus)
  • ​Lupin looks to launch 25 products in US this fiscal( Economic Times)
  • ​Pfizer plans to bring more global drugs to India ( Economic Times)
  • Major Shift As Deaths From Cancer Overtake CV Disease In Western Europe ( CardioBrief) ( OnMedica)
  • CFDA releases manufacturing guidance ( BioCentury)
  • Merck's Indian unit MSD may sell primary care drugs to focus on core brands ( Economic Times)
  • Pharma Entrepreneur Becomes China's Newest Billionaire As Stocks Reach 7-Month High ( Forbes)
  • Gilead Says Indian Co. Is Infringing HIV Drug Patents ( Law360-$)

US: Pharmaceuticals & Biotechnology

  • A plague on pharma? Where and why reimbursement has become such a hurdle, and the keys to overcoming it ( PharmaLetter-$)
  • Surprise! It's A Phase III Failure  ( SCRIP-$)
  • Major drug partnership aims to develop new cancer drug ( MedCityNews)
  • Why Medical Affairs is the Cornerstone for Building Trust in our Industry ( Pharmaceutical Compliance Monitor)
  • Will Your Prescription Meds Be Covered Next Year? Better Check ( NPR)
  • Basilea drops inhaled antibiotic, expands cancer program in early-stage rejig ( Fierce)
  • Pharmaceutical Lobby Shakeup Precedes Drug Price Battle ( Roll Call)
  • Number of babies born with opioid dependence has tripled in US, says CDC report ( Pharmafile)
  • ANDA Approvals, Submissions Decline With New Review Goal Coming ( Pink Sheet-$)
  • AZ trumpets positive COPD data to help Symbicort stand up to rivals ( Fierce)
  • FDA Efforts Continue to Make its Inactive Ingredient Database More Functional ( IPQ)

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

  • Aurinia Pharmaceuticals' lupus candidate hits PhII target ( Fierce) ( Press)
  • Advaxis follows up Amgen deal with Phase IIa cancer trial success ( Pharmafile)
  • Promising results for new type 2 diabetes management procedure ( Press)
  • Acacia's PONV therapy passes latest Phase III test ( BioCentury)
  • Tivorsan Pharmaceuticals Granted FDA Orphan Drug Designation for Human Recombinant Biglycan in the Treatment of Duchenne Muscular Dystrophy ( Press)
  • NovaDigm Therapeutics Announces Positive Results from First-ever Antifungal Immunotherapy in a Phase 2a Study in Women with Recurrent Vulvovaginal Candidiasis (RVVC) ( Press)
  • Results from Phase 1 Trials with Ligand's LGD-6972 in Type 2 Diabetes Mellitus Published in Diabetes, Obesity and Metabolism ( Press)

US: Medical Devices

  • FDA Finalizes 510(k) Guidance for Electrosurgical Devices ( Focus)
  • Dutch coating supplier's recall gives Cook Medical another headache ( MassDevice)
  • Lumicell aims to reduce repeat surgeries in breast cancer ( MedCityNews)
  • New MRI technology could be placed outside shielded zones ( MedCityNews)
  • Nonprofit ECRI Hopes New Genetic Test Database Can Help Track Validity, Utility Evidence ( GenomeWeb)
  • Edwards Intuity Elite Rapid Deployment Valve Receives FDA Approval ( Press)
  • Fractyl touts 1st-in-human data, grabs ex-GI Dynamics medical chief Maggs ( MassDevice)
  • NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results ( FDA 1, 2)

US: Assorted & Government

  • FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance ( FDA Law Blog)
  • Two Favorable Tysabri Rulings Add Clarity to "Clear Evidence" Preemption Standard ( Drug and Device Law)
  • FDA Finalizes Voluntary GRAS Notification Process, CFA Explores Legal Options ( Inside Health Policy)
  • Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines ( FDA)

Upcoming Meetings & Events


  • SANTE meeting with EPF ( Minutes)
  • Mallinckrodt Plans to Purchase Skin Substitute Developer Stratatech ( GEN) ( Press)
  • Fraud Rounds: Grant Fakery Earns UK Practice Ban ( Medpage)


  • WuXi AppTec's STA Subsidiary Passed Third U.S. FDA Inspection ( Press)


  • Cipla's CEO Departs Amid "Text-Book" Succession Plan For Future ( SCRIP-$)
  • Expanding markets, launching new products for growth: Wockhardt ( Economic Times)


  • TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016 ( TGA)


  • Summary Safety Review - Antidepressants - Assessing the Potential Risk of Serious Eye Disorder (Angle-Closure Glaucoma) ( Health Canada)


  • Another Zika case reported outside Miami's transmission zone ( Reuters)
  • As New York Fights Zika Virus, Officials Turn Their Focus to Sex ( NYTimes)

General Health & Other Interesting Articles

  • PROMS show health improvement post surgery ( PharmaTimes)
  • Don't Throw Out Your Organ Donor Card After 65 ( 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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