Regulatory Recon: CRISPR Won't Help Sick Patients Soon EU Device Regulation to Move Forward in June (4 May 2016)

Posted 04 May 2016 | By Michael Mezher 

Regulatory Recon: CRISPR Won't Help Sick Patients Soon EU Device Regulation to Move Forward in June (4 May 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

  • FDA Warns of Rare Impulse Reactions to Abilify Medication (WSJ-$) (Medpage) (PharmaLetter-$) (FDA) (Focus)
  • The gene editor CRISPR won't fully fix sick people anytime soon. Here's why (Science)
  • Pondering 'what it means to be human' on the frontier of gene editing (Washington Post)
  • What We Mean When We Talk About EvGen Part II: Building Out a National System for Evidence Generation (FDA Voice)
  • US prosecutors consider More Charges Against ex-CEO Shkreli (Reuters) (The Guardian)
  • Pfizer Weighs Split to Cut Tax Bill (Financial Times)
  • Opioid REMS Impact Unclear (Medpage) (Pink Sheet-$)
  • FDA Amends Regulations on General Biologic Standards for First Time Since 1977 (Focus)
  • NIAID: Local Zika Outbreak 'Likely' in U.S. (Medpage)
  • Why it took so long for Sarepta to start a big trial of its Duchenne drug (Boston Business Journal)
  • First GOP rep backs Obama's Zika funding request (The Hill)

In Focus: International

  • The World's Most Expensive Medicine Is a Bust (MIT Technology Review)
  • New European Medical Device Regulation taking next step forward in June? (Emergo)
  • EMA Approves Save the Children-GSK Developed Umbilical Cord Disinfectant Gel (NYTimes)
  • Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (Focus)
  • Germany Relaxes Rules on Using Cannabis for Medical Purposes (Reuters)
  • Candidate Ebola therapy fails to improve survival in clinical trial (Pharmaceutical Journal)
  • Sanofi Asked to Conduct Phase III Clinical Trials of its Dengue Vaccine in India (24 insight)
  • European Medicines Agency closed 5-9 May 2016 (EMA)
  • Real-World Success Seen With Infliximab Biosimilar (Medpage)
  • Botched French Drug Trial Followed Rules But Lacked 'Common Sense' (NPR)
  • NICE fast-tracks Novartis' skin cancer combination (PharmaPhorum)
  • EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients (In-PharmaTechnologist)
  • Germany's IQWiG unable to find added benefit for GSK's Nucala (PharmaLetter-$)
  • NICE extends price-negotiation talks for PTC' muscle wasting drug (Pharmafile)
  • China Probe Reveals Widespread Data Violations At Major Study Centers (PharmasiaNews-$)

US: Pharmaceuticals & Biotechnology

  • Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01) (FDA)
  • Pfizer Reports Rock-Solid Quarter, Sees Stronger Year Ahead (WSJ-$) (The Street) (Reuters)
  • FDA Calls for Head-to-Head Trials in Revised Draft Guidance on Hepatitis C Drugs (Focus)
  • Precision for Medicine acquires Applied Immunology (PharmaLetter-$)
  • An Analytics Approach to Designing Combination Chemotherapy Regimens for Cancer (Management Science)
  • Therapy focus – NASH projects set for data in dog days of summer (EP Vantage)
  • Videogamers Are Recruited to Fight Tuberculosis and Other Ills (WSJ-$)
  • Why Acadia Pharma's First Drug Approval Isn't Moving Stock Higher (The Street)
  • More Young Children with ADHD Could Benefit from Behavior Therapy (CDC)
  • Genomic Variant Data Sharing Gains Support; Collaboration Seen as Key to Interpretation Challenge (GenomeWeb)
  • Octapharma recalls Octagam lot in US (BioPharma-Reporter)
  • FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries (MNT)
  • Shire: 'Baxalta brings us world-class manufacturing network' (BioPharma-Reporter)
  • Potentially Thicker Tablets Prompt Antidepressant Recall (MPR)
  • Cancer Drugs Tested with Flawed Time-based Method, Says Vanderbilt Study (DD&D)
  • Avastin, Lucentis equal in five-year AMD study (BioCentury)
  • FDA Latest Opioid Dilemma: Can Apadaz Stop Snorting Abuse – And Does That Even Matter? (Pink Sheet-$)
  • Pfizer joins the race, bids for Medivation – Reports (Pharmafile)
  • BERG using AI in pancreatic cancer research (PharmaPhorum)
  • New-Gen EVAR Tech Should Allay Concerns Over Not-So-Favorable New Data (Clinica-$)
  • Age-related macular degeneration before and after the era of anti-VEGF drugs (NIH)
  • Sales of Merrimack's new pancreatic cancer drug top $11M in Q1 (Boston Business Journal)
  • US biotech company to try resurrect the clinically dead (Pharmafile)
  • Santhera submits FDA meeting request to discuss Raxone NDA (PharmaLetter-$)
  • Placing quality and innovation at the heart of drug development (Outsourcing-Pharma)

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

  • FDA Grants Priority Review for Lilly's Olaratumab, an Investigational Medicine for Advanced Soft Tissue Sarcoma (Press)
  • FDA grants priority review for Amgen leukaemia drug (Pharmafile)
  • Isarna Presents First Interim Phase I Data for ISTH0036 in Advanced Glaucoma at ARVO 2016 Annual Conference (Press)
  • Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma (Press)

US: Medical Devices

  • On Road To Bankruptcy A Stent Company Invested in Marty Leon's VC Fund (CardioBrief)
  • Hacking Medicine's consumer health app review site launches (MobiHealthNews)
  • Medtronic Hires New Chief Financial Officer (WSJ-$)
  • Cook Medical Issues Global, Voluntary Recall of Catheters with Beacon Tip Technology (FDA)
  • Class I Recall of B Braun Hemodialysis Machines (FDA 1, 2, 3, 4, 5, 6)
  • Medtronic touts 7-year follow-up data on 2-level Prestige LP disc (MassDevice) (Press)
  • Sunshine Heart pares losses, preps for 1st-in-human trial for C-Pulse heart failure device (MassDevice)
  • Biotronik wins FDA nod for Iperia ProMRI HF-T defibrillator (MassDevice) (Press)
  • Boston Scientific Announces US FDA Approval of Navigation-Enabled Ablation Catheters (Press)

US: Assorted & Government

  • Carter, As Sole Pharmacist In Congress, Upset He Wasn't Consulted On FDA Compounding Guide (IHP-$)
  • Public And Private Insurers Pay The Majority Of Opioid Costs (Forbes)
  • Medical Errors May Cause Over 250,000 Deaths a Year (NYTimes)
  • Prior Authorization Policies for Pediatric ADHD Medication Prescriptions (Harvard Bill of Health)
  • Johnson & Johnson Faces Growing Threat of Lawsuits Over Talc and Cancer (WSJ-$)
  • HHS OIG Revises Factors Used to Evaluate Whether to Exclude Based on Health Care Fraud Activities (FDA Law Blog)
  • Allergan, Others Hit With Another Drug Price-Fixing Suit (Law360-$)
  • Mylan Wins PTAB Review Of Diabetes Drug In Rare Rehearing (Law360-$)
  • Citizen Petition Requests FDA Ban Certain Phthalates; Revoke Clearances for Others (National Law Review)
  • Bio-rad Laboratories v. California Institute of Tech: Final Written Decision Finding No Inconsistency between Expert Testimony and Earlier Paper by Same Expert IPR2015-00009 (National Law Review)

Upcoming Meetings & Events


  • Servier's Lonsurf approved in advanced colorectal cancer in EU (PharmaPhorum) (Pharmaceutical Journal)
  • Witty looks to cement his legacy as GSK's performance improves (Financial Times)
  • Agilis Biotherapeutics Announces Orphan Designation Approval in Europe for the Treatment of Angelman Syndrome (Press)
  • Should we know if healthcare professionals are being paid by drugs companies? – poll (The Guardian)
  • Goodwin selected to make bispecific antibody candidate for Russian firm (BioPharma-Reporter)


  • China Investigates Search Engine Baidu After Student Dies Of Cancer (NPR)
  • Cynata's stem cell technology receives Japanese patent (BioSpectrum)
  • Polluted air may up risk of many cancers (Reuters)
  • Samsung on Samsung: Bioepis selects Biologics as a biosimilars CMO (BioPharma-Reporter)
  • Taiwan discovers new molecule that can arrest breast cancer spread (BioSepctrum)
  • Chinese Cos increase services in finished dosage, exports and bio services at CPhI China 2016 (BioSpectrum)


  • ICGEB, Sun Pharma tie-up to develop novel dengue drug (Economic Times)
  • Pfizer Obtains Accelerated Path Towards Indian Approval For Ibrance (24 Insight)
  • India To Create Committee To Implement WTO Trade Facilitation Agreement (24 Insight)
  • USFDA Approves Aurobindo's Anda For Pfizer's Toviaz (24 Insight)
  • Karnataka's health policy to define treatment cost for four categories (Economic Times)


  • Prescription medicines: new or extended uses of registered medicines (TGA)
  • Australian government praised for commitment to med subsidies (PharmaLetter-$)


Other International

  • U.N. hails landmark ruling by Sri Lanka's top court to outlaw HIV discrimination (Reuters)
  • U.S.-funded abstinence programs not working in Africa (Reuters)

General Health & Other Interesting Articles

  • The Conventional Wisdom About Treating Concussions In Children Might Be Wrong (Forbes)
  • Jury still out on celiac disease screening, U.S. doctors say (Reuters)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles