Regulatory Recon: Republicans Approve $1.1Bn to Fight Zika UK Votes on 'Brexit' Today (23 June 2016)

Posted 23 June 2016 | By Michael Mezher 

Regulatory Recon: Republicans Approve $1.1Bn to Fight Zika UK Votes on 'Brexit' Today (23 June 2016)

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

  • Republicans Approve $1.1 Billion in Zika Funds, White House Slams Proposal as Inadequate  (Reuters 1, 2) (Senate) (Bill) (Vote) (SCRIP-$)
  • FDA Celebrates the 40th Anniversary of the Medical Device Amendments (FDA Voice)
  • The Immuno-oncology Traffic Jam (In the Pipeline)
  • Zika, Flint, And The Uncertainties Of Emergency Preparedness (Health Affairs Blog)
  • Pfizer closing Hospira plant in Colorado, 100 jobs to be lost (Fierce)
  • FDA Warns Medtronic Subsidiary Over Adulterated Devices (Focus)
  • US Supreme Court weighs review of canceled patent on prenatal test (Reuters)
  • New Ways to Treat Pain Meet Resistance (NYTimes)
  • A Cautionary Tale of 'Stem Cell Tourism' (NYTimes) (Boston Globe)
  • Medicare Part D spending on compounded drugs is skyrocketing (STAT)
  • Commissioner Califf commits to tackling staffing issues at US FDA (In-PharmaTechnologist)
  • Justice Department Announces Biggest Medicare Fraud Crackdown (WSJ-$) (DoJ)
  • Stopping Runaway Tests And Healthcare Costs (Forbes)
  • Obama Signs Chemical Safety Bill Into Law (Focus) (Washington Post)
  • AstraZeneca takes $80 million hit as US spurns nasal flu vaccine (Reuters) (PMLive)
  • Is There a Cure for High Drug Prices? (Consumer Reports)
  • The House Republicans' Health Plan (Health Affairs Blog)
  • Sanofi Said to Consider Adding Future Payments to Medivation Bid (Bloomberg) (Pharmafile)
  • FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics (Focus)
  • No 'Unicorn' High-Cost/High-Volume Drugs Expected For 2017 (Pink Sheet-$)

In Focus: International

  • Bill to amend existing Drugs Act withdrawn (Economic Times 1, 2)
  • EU referendum polls: The latest Brexit tracker odds and will there be an exit poll? (The Telegraph)
  • Fate of European Union Rests in the Hands of British Voters Today (The Street) (PharmaTimes) (Pharmafile)
  • Mylan Says Indian Drug Industry Needs More Transparency From FDA (Bloomberg)
  • NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta (Focus)
  • Cancer Drug Causing A World Of Pain (Sunday Leader)
  • NZ's PHARMAC consults on proposed listing of Praxbind and Pradaxa (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Interview – Tocagen touts two-step cancer vaccine (EP Vantage)
  • Pharma Twitter Activity (Eye on FDA)
  • FDA Pilot Project to Test New Import Communication System (Focus)
  • Timely use of Novartis' Entresto could prevent/delay over 28,000 US deaths a year – study (Pharmafile)
  • Cellular Dynamics, National Eye Institute Announce Another Tie-up (Xconomy)
  • Time For Cardiologists To Start Prescribing Diabetes Drugs? (CardioBrief)
  • New Humira data shows improved quality of life in ulcerative colitis patients (Pharmafile)
  • Real-World Evidence Is Versatile, Commissioner Califf Says: 'Use It For The Right Purposes' (Gray Sheet-$)
  • Real-World Study Compares Treatment Persistence, Discontinuation of Oral Anticoagulants in Afib Patients (MPR)
  • Regulatory INN security? Sandoz disputes proposed biosimilar naming guidance (BioPharma-Reporter)
  • Novo's Tresiba hits the airwaves with new TV campaign (Fierce)
  • Shkreli Fallout Continues: PhRMA Seems To Soften Stance On REMS Legislation (Pink Sheet-$)
  • FDA approves Sabril REMS modifications (PharmaLetter-$)
  • Lowered lipid levels not always better in statin therapy (Pharmaceutical Journal-$)
  • Celgene backs four NCI Cancer Centers with $50M to create research consortium (Fierce)
  • Incyte shrugs off trial failures with Merck PD-1/epacadostat tie-up (Fierce)
  • IPAB delay boosts biotech markets (BioCentury) (SCRIP-$)

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

  • Ixekizumab clears psoriasis in up to 80% of patients (Pharmaceutical Journal-$)
  • Ardelyx's Adjusted Trial Design May Expedite NDA Filing For Lead Candidate (Pink Sheet-$)
  • Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam) (Press)
  • Phase I/II trial of INCAGN1876 in solid tumours starts (EPR)
  • FDA Grants Breakthrough Therapy Designation for Incyte's Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease (GVHD) (Press)
  • Cerulean Announces First Patient Dosed in Phase 2a Expansion Stage Evaluating CRLX301 in Patients with Advanced Solid Tumors (Press)
  • Pluristem reports data showing PLX-PAD cells effective in treating Duchenne muscular dystrophy (MNT)

US: Medical Devices

  • FDA bans importation of Berwickshire's Helica thermal coagulator and probes (MassDevice)
  • Abbott touts data from rotor-ablation AF trial (MassDevice)
  • Terumo snags $17.4M in fed funding to study its Mirasol-treated platelets in plasma (Fierce)
  • Philips ad for lung device wins top honors at Cannes (BioPharmaDive)
  • Regulatory Highlights from the First Half of 2016 (MDDI)
  • Are You in Compliance with New Medical Device Postmarket Surveillance Requirements? (MDDI)
  • FDA Issues Draft Guidance Describing Benefit-Risk Factors Taken Into Account In Post-Market Compliance Decisions (FDA Law Blog) (Focus)
  • IBM creates medical imaging collaborative to improve personalized care, reduce inefficiencies (Fierce)

US: Assorted & Government

  • Latest on Personal Jurisdiction – Using Bauman To Quash Third-Party Subpoenas (Drug and Device Law)
  • Heroin use at 20-year high in US drug 'epidemic', U.N. says (Reuters)
  • Department of Health and Human Services, Food and Drug Administration: Food Labeling: Revision of the Nutrition and Supplement Facts Labels (GAO)
  • Rates of nonmedical prescription opioid use and opioid use disorder double in 10 years (NIH)
  • Prescription Drug Monitoring Programs Help Reduce Opioid-Related Death Rates (Health Affairs Blog)
  • ERs are proving ground for patient data sharing initiatives to cut costs (MedCityNews)
  • Common Law And Common Sense: The Supreme Court Redresses Patient Harm Under The False Claims Act (Health Affairs Blog)
  • Exclusive: Analysis suggests Anthem deal could raise health costs (Reuters)
  • Appeals court won't review J&J's Ethicon loss in stapler patent spat with Covidien (MassDevice)
  • Plan To Sue A Slipshod Supplier To Recoup A Civil Litigation Judgment? When It Comes To Implantable Device Parts, You May Have To Think Again (Gray Sheet-$)
  • Drug Enforcement Administration: Additional Actions Needed to Address Prior GAO Recommendations (GAO)
  • Zimmer's Cayenne Medical buries the hatchet with MedShape after patent board loss (MassDevice)
  • FDA Delay Of Drug Labeling Rule Is Bad News For Plaintiffs (Law360-$)

Upcoming Meetings & Events


  • Nokia Technologies plans move into regulated clinical devices via Finnish hospital partnership (MobiHealthNews)
  • Revision: Post-orphan medicinal product designation procedures (EMA)
  • Medicines and Healthcare products Regulatory Agency spending over £25,000: 2016 to 2017 (MHRA); £500: 2015 – 2016 (MHRA)
  • Orifarm starts Cialis recall on counterfeit concerns (Securing Industry)
  • GE confirms Britain is better in Europe ahead of Thursday's vote (BioPharma-Reporter)
  • Biogen promotes Paul McKenzie to executive vice president (Pharmafile)
  • European Commission Grants Marketing Authorization for Gilead's Single Tablet Regimen Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV (Press)
  • NeuroMetrix seeks CE Mark for Quell OTC pain relief device (MassDevice)
  • NEUROCAP for Prevention of Neuromas on Severed Nerves Cleared in EU (medGadget)


  • Sanofi Dives Deep Into Communities As China Elevates GPs' Role (PharmAsiaNews-$)
  • Medical Device Sourcing in China: Key Issues for Foreign Companies (MDDI)
  • China's Ascletis reports positive interim PhII on interferon-free HCV candidate (Fierce)
  • The Institute of Medical Science, the University of Tokyo and Astellas Enter into a New Collaborative Development Agreement for Rice-Based Oral Vaccine (Press)
  • Waters collaborates with A*star to expand biomarker discovery (BioSpectrum)


  • Government invites entries for NPPA logo (Economic Times)
  • Biocon, Quark get DCGI nod for trials of new eye disease drug (Economic Times)
  • Sun Pharma bets on new products to boost US skincare products growth (Economic Times)


  • Cipher Pharma out-licenses rights to ASF-1096 to Edesa Biotech (PharmaLetter-$)
  • Request for Registration for the 2016 Health Products and Food Branch (HPFB) International Regulatory Forum (Health Canada)


  • Important annual charge deadlines (TGA)


  • Brazil budget crisis slows supercomputer from studying Zika (Reuters)

Other International

  • WHO to launch emergency yellow fever vaccination in Angola, Congo (Reuters)
  • Congo almost runs out of yellow fever vaccine amid epidemic (Reuters)

General Health& Other Interesting Articles

  • Lab-Grown Bones Successfully Implanted in Pigs (NYTimes)
  • Cancer Is Contagious Among Clams. What About Us? (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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