Regulatory Focus™ > News Articles > Regulatory Recon: FDA Reschedules Sarepta DMD Panel, EMA Fee Increase Set for April (10 March 2016)

Regulatory Recon: FDA Reschedules Sarepta DMD Panel, EMA Fee Increase Set for April (10 March 2016)

Posted 10 March 2016 | By Michael Mezher 

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

  • Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 (Focus)
  • FDA Schedules Sarepta Panel for 25 April 2016 (FDA)
  • N-of-1 Policymaking — Tragedy, Trade-offs, and the Demise of Morcellation (NEJM)
  • CMS Seeking 'Collaborative' Response To Part B Payment Model – Slavitt Tells PhRMA (Pink Sheet-$)
  • Groups Scrutinize White House Plan to Cut Drug Costs in Medicare (NYTimes) (WSJ-$)
  • Medicare Tries an Experiment to Fight Perverse Incentives (NYTimes)
  • This drug is defying a rare form of leukemia — and it keeps getting pricier (Washington Post)
  • Amarin Proposed Settlement Signed by Judge (FDA Law Blog) (Settlement)
  • Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills (Focus)

In Focus: International

  • EU Trails FDA In Device Cybersecurity Guidance, But Harmonization Anticipated (Gray Sheet-$)
  • EMA Annual Fee Increase Set for 1 April 2016 (EMA)
  • MHRA Issues Urgent Warning Over Defective Hearing Aid Batteries (GOV.UK)
  • Israeli placental cell therapy could cure radiation sickness (Reuters)
  • Roche v. Biocad – Patent Litigation Likely to Shape Russia's IP Landscape (National Law Review)

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US: Pharmaceuticals & Biotechnology

  • Industry consortium aims to take the pain out of ICH Q3D compliance (In-PharmaTechnologist)
  • How To Respond to FDA 483s and Warning Letters (MedCityNews)
  • Sentinel's "IMPACT" Beyond Safety: Anti-Coagulant Study Is Early Test (RPM Report-$)
  • 6 Ways Pharma May Use Social Media (Forbes)
  • Stem Cells Show Promise as Cataract and Blindness Treatments (WSJ)
  • Surviving drug shortages by eliminating the middlemen (Modern Healthcare-$)
  • Zarxio one year on: US biosimilars market still riddled with uncertainty, expert (BioPharma-Reporter)
  • Twitter for #ClinicalTrials recruitment? Researchers see the potential (Outsourcing-Pharma)
  • Sticking with tradition: clinical trial sites prefer paper records (Outsourcing-Pharma)
  • Merck's Zepatier added to VA formulary (BioCentury)
  • Medivation's mystery cancer drug gets out from an FDA hold (Fierce)
  • Opinion: How to Reduce Medicare Drug Costs (NYTimes)
  • Q&A: The state of generics with GPhA's Chip Davis (DSN)
  • Compounds restore antibiotics' efficacy against MRSA (MNT)
  • I/O therapies boosting R&D funding & alliances, says Tufts (Outsourcing-Pharma)
  • Rival to rare disease blockbuster Soliris moves ahead (PharmaPhorum)
  • Screening Enormous Databases to Find a Cure for Cancer (DD&D)
  • Pharma's reputation with patient groups hits four-year high (PharmaTimes)
  • Epizyme Has Aggressive Plans For Accelerated Approval For Tazemetostat (Pink Sheet-$)
  • 2015 Year in Review: OPDP and APLB Warning and Untitled Letters (King & Spalding)

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

  • Pfizer Announces Publication of Study Results of BeneFIX Coagulation Factor IX (Recombinant) Once-Weekly Prophylaxis for Hemophilia B (Press)
  • Positive results from Phase III study of RHB-105 for H. pylori infection (EPR)
  • Viamet Reports Positive Results from Interim Analysis of REVIVE Phase 2b Trial of VT-1161 in Recurrent Vulvovaginal Candidiasis (Press)
  • Ignyta Announces Selection of Recommended Phase 2 Dose and Initiation of Phase 1b Basket Trial of RXDX-105 (Press)
  • Enzo Biochem Submits AmpiProbe Based Assay Targeted at Women's Health for Approval to New York State Department of Health (Press)

US: Medical Devices

  • Device Makers Need to Prepare For Move to Increased Outpatient Procedures (MDDI)
  • Center for Devices and Radiological Health: Experiential Learning Program for 2016 (FDA)
  • 'Connectivity Bridge' appears to be Google's new hub for transmitting health data (Silicon Valley Business Journal) (MassDevice)
  • Theranos competitor HealthTell raises $26M for single-drop-of-blood diagnostics that profile immune response (MedCityNews)
  • FDA warns Repro-Med on Freedom Infusion set issues, company response (MassDevice) (Press)
  • JAMA study is the latest to examine health app privacy policies (MobiHealthNews)
  • Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems (FDA)
  • NIH awards grant to upstart for nanotech, regenerative spinal implants (Fierce)
  • Wanda Automatically Connects Medical Devices to Nearby Networks (medGadget)
  • Visunex Medical wins FDA nod for infant visual imaging system (MassDevice)
  • Published study demonstrates Natera's ability to identify heterogeneous cancer mutations in patients with early-stage lung cancer (MNT)
  • Preliminary data demonstrates 86% accuracy in detecting idiopathic pulmonary fibrosis, a fatal lung disease (MNT)
  • ReVision Optics touts 1-year data for Raindrop inlay (MassDevice)

US: Assorted & Government

  • FDA Wouldn't Get Funding Boost As Part Of Senate GOP Innovation Bill (Pink Sheet-$)
  • The Physician Payments Sunshine Act — Two Years of the Open Payments Program (NEJM-$)
  • Mass. State House Passes First Time Opioid Prescription Bill (WBUR)
  • Electronic records lag at hospitals U.S. doesn't pay for tech upgrades (Reuters)
  • Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate (Health Affairs Blog)
  • Mass Torts Made Perfectly Convivial - the Sequel (Drug and Device Law)
  • Women lag men as lead authors in top medical journals (Reuters)
  • Senate panel votes to add Zika to controversial FDA review voucher program (Modern Healthcare-$)
  • FTC Chief Tells Sens. Agency Not Ignoring Drug Price Hikes (Law360-$)
  • Fed Circ. Urged To Invalidate Illumina Sequencing Patent (Law360-$)
  • Novo Nordisk Hemophilia Drug Flouts Patent, ITC Judge Says (Law360-$)

Upcoming Meetings & Events


  • HIV vaccine developer Theravectys says GMP suspension at Paris plant won't delay trial (In-PharmaTechnologist)
  • An NHS that learns from mistakes (GOV.UK)
  • St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker (Press)
  • EUnetHTA JA2 joint assessments – both output and process matters for successful national uptake (EUnetHTA)
  • Proud Latvia regrets ban on meldonium drug its scientists invented (Reuters)


  • Japan's AMED names 8 projects for pre-designation orphan review (Fierce)
  • UL provides medical device manufacturers alternative to traditional CFDA testing (MassDevice)
  • China FDA approves Roche's cervical test CINtec (Fierce)
  • Warning about counterfeit GSK eye drops in Singapore (Securing Industry)


  • Chemists oppose FDA's circular directing dispensing of cut strips to patients (PharmaBiz)
  • Japan invites Indian pharma cos to set up units there to meet growing demand of generic drugs (PharmaBiz)
  • Unichem Lab gets USFDA nod for schizophrenia tablets (Economic Times )
  • Drug price control decision only after industry discussion: Hansraj Gangaram Ahir (Economic Times)
  • Maha FDA issues prosecution orders in 90 cases of NSQ drugs (PharmaBiz)


  • Mums The One one step hCG urine pregnancy test (TGA)
  • Ampicillin injection and Amoxycillin injection - medicine shortages (TGA)

Zika Virus

  • Mosquito spraying may not stop Zika, other methods needed: WHO (Reuters)
  • WHO and experts prioritize vaccines, diagnostics and innovative vector control tools for Zika R&D (WHO)
  • Taiwan and Hainan at Risk of Zika Spread, Scientist Warns (NYTimes)
  • Brazil lowers limit of measure for microcephaly, but cases rising (Reuters)
  • Zika-Linked Nerve Disorder Unsettles Colombia (WSJ-$)
  • Zika Vaccine Still Years Away, WHO Says (NYTimes)
  • Could climate change be the culprit in spread of Zika virus? (LA Times)

Other International

  • More Than 2 Million People Co-infected With HIV and Hepatitis C (DD&D)
  • Low cost, 25 min TB-test could help reduce tuberculosis death rate among patients with HIV in sub-Saharan Africa (MNT)

General Health & Other Interesting Articles

  • Banned Drug Sharapova Took Is Widely Used, Study Shows, Despite Little Evidence That It Boosts Performance (Forbes)
  • How Does Meldonium, The Drug Maria Sharapova Took, Work? (Forbes)
  • First Uterus Transplant in U.S. Has Failed (NYTimes)
  • New Procedure Allows Kidney Transplants From Any Donor (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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