Regulatory Recon: Breakthrough Status for Roche & AstraZeneca Drugs, New Insights on EU Medical Device Regulation (17 February 2016)

Posted 17 February 2016 | By Michael Mezher 

Regulatory Recon: Breakthrough Status for Roche & AstraZeneca Drugs, New Insights on EU Medical Device Regulation (17 February 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

  • Analysis: Fewer 510(k) Submissions from US Medical Device Firms in 2015 (Emergo)
  • What is FDA Doing to Improve the Health of African-Americans? (FDA Voice)
  • FDA Sees Spike in Gene and Cell Therapy Applicaions (Focus)
  • Why hack the FDA? (Federal Times)
  • AstraZeneca wins FDA breakthrough status for key cancer drug (Reuters)
  • FDA gives ocrelizumab breakthrough designation for PPMS: Roche (Reuters) (Press)
  • With Special Tax Suspended, Medical Device Firms Reap Big Savings (NPR)
  • How a Reporter Pierced the Hype Behind Theranos (ProPublica)

In Focus: International

  • Inside the Economics of the First GM Mosquito (MIT Technology Review)
  • For vaginal repair, benefits of mesh must be weighed against harms (Reuters)
  • New white paper on EU MDR (and where is the MDR anyway?) (MedicalDevicesLegal)
  • Asian Harmonization Group Cuts Own Path In Combination Products Reg (Gray Sheet-$)
  • How is transparency going at the European Medicines Agency? (AllTrials)

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US: Pharmaceuticals & Biotechnology

  • The Birth Of An Orphan Biosimilar Market (In Vivo-$)
  • Survey: Biopharma gets a bad grade on gender diversity (Fierce)
  • New Drug Ads Tout Serious Conditions, Costly Treatments (WSJ)
  • Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse (Press)
  • FDA Seeks Input on Drug Supply Chain Security Pilot Program (Bloomberg)
  • Resolve Increasingly Complex Physician And Patient Requests By Involving All Medical Information Teams (Cutting Edge Info)
  • Notable Deals in the Pharmaceutical Industry in the 4th Quarter of 2015 (Thomson Reuters)
  • It's not just payers waiting on PCSK9 outcomes data. Doctors are holding back, too (Fierce) (Reuters)
  • Should FDA Be Solely To Blame For Slow BPCIA Formation? (BioProcessOnline)
  • FDA Releases Guidances On Trial Designs for Rhinitis, Anthrax Drugs (FDANews-$)
  • Advanced Care Infusion Lands Warning Letter Over Sterile Drug Practices (FDANews-$)
  • Quantifying The Carnage: Biotech IPO Markets In Turmoil (Forbes)
  • No, Human Embryos Won't Be Genetically Modified To Create Designer Babies (Forbes)

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

  • Flexion's Zilretta bound for NDA submission (BioCentury) (Reuters)
  • Mesoblast's cell therapy leads to RA responses (BioCentury)
  • Tonix tanks on a Phase II flop for its headache drug (Fierce) (Press)
  • Bone Therapeutics Treats 12 Patients without Safety Concerns in ALLOB Phase IIA Spinal Fusion Trial (Press)
  • bluebird bio Announces First Patient Treated with bb2121 in CRB-401 Phase 1 Study in Patients with Relapsed/Refractory Multiple Myeloma (Press)
  • Ocular Therapeutix™ Announces Phase 3 Clinical Development Plan for OTX-TP, an Innovative Therapy for Glaucoma and Ocular Hypertension (Press)
  • Impax Receives FDA Approval for Generic Version of Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, CII (Press)

US: Medical Devices

  • 2016 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel (FDA)
  • Plastics In Artificial Joints: FDA Offers Submission Tips In Draft Guidance (Gray Sheet-$)
  • Medical Devices Head for Pharma-Type Public Ads (MDDI)
  • Clear Guide Medical wins 510(k) for Scenergy image guidance (MassDevice)
  • ReWalk chalks up reimbursement win for exoskeleton system(MassDevice)
  • FDA approves trial for J&J's Mentor MemoryGel breast implant (MassDevice)
  • Developing Devices with 3-D Printing and FEA Software (MDDI)
  • Stent Electrode Reads Brain Signals From Inside a Vein (IEEE Spectrum)
  • An Exoskeleton Spine Brace for Scoliosis (IEEE Spectrum)
  • Mammography Facility Adverse Event and Action Report - February 16, 2016: Boston Diagnostic Imaging (FDA)
  • New test detects chlamydia in 30 minutes (MNT)
  • St. Jude Medical Receives FDA Approval for Industry's First MultiPoint Pacing Technology (Press)
  • BD Receives FDA 510(k) Clearance for New Blood Collection Device to Help Enhance Patient and Clinician Experience (Press)
  • Masimo Announces FDA 510(k) Clearance for Root® with Noninvasive Blood Pressure and Temperature (Press)
  • FDA expands approval for Medtronic's deep-brain stimulation for Parkinson's (MassDevice) (Press)

US: Assorted & Government

  • Califf and the Rules on Holds (RPM-Report-$)
  • Five Healthcare-Related Cases Scalia Left Behind (MedpageToday)
  • Pfizer to Pay $785 Million to Settle Medicaid Claims (WSJ-$)
  • Couple to Give $7.2 Million Toward Efforts to Lower Drug Prices (WSJ)
  • Hollywood Presbyterian declares emergency after hackers cut off data, demand $3.4 million ransom (HealthcareIT)
  • GAO Report on the Safety of Drugs Approved Using Expedited Programs Finds Shortcomings in FDA's Postmarket Oversight, Reviews Use of Expedited Programs Instead (FDA Law Blog)
  • Open Payments 2016 Updates: Companies Should Report Retired and Deceased Doctors (Policy and Medicine)

Upcoming Meetings & Events


  • Pharma Calls For More Regulatory Simplification From EMA's Article 57 Database (SCRIP-$)
  • EU Medtech Could See Regulatory And HTA Requirements Entwined (Clinica-$)
  • IRIDEX moves forward in commercialization of laser system to treat glaucoma, Gets CE Mark (MedCityNews)
  • Fusafungine-containing medicines should be withdrawn, says European Medicines Agency (Pharmaceutical Journal-$)
  • IQWiG now finds considerable benefit for Eklira in certain patients (PharmaLetter-$)
  • EMA's CHMP gives Proteus positive opinion for use of ingestible to measure drug adherence in clinical trials (Fierce)


  • India aims to detail new policies next month to boost bulk drug output (Fierce) (Economic Times)
  • CDSCO to grant online registration certificate, renewal of licence for import of medical device soon (PharmaBiz)
  • Awaiting USFDA response on remediation efforts of 3 units: Dr Reddys Laboratories (Economic Times)
  • GSK plans $73 million upgrade to Nashik plant in India (Fierce)
  • BIRAC to support biotech cos for affordable bio-pharma development in identifying novel tools/technologies (PharmaBiz)
  • Govt to set up two dedicated medical device testing labs for first time in India (PharmaBiz)
  • Glenmark gets tentative nod from USFDA for azelaic acid gel (Economic Times)
  • Govt approves investment by FIL Capital in Cipla Health (Economic Times)


  • Hand, Foot, and Mouth Disease in China: Modeling Epidemic Dynamics of Enterovirus Serotypes and Implications for Vaccination (PLOS)


  • Eisai and PIQUR team up for breast cancer drug trials (PharmaLetter-$)
  • Fresenius acquires Japan's largest dialysis group (MassDevice)


  • Abbott's FreeStyle Libre glucose monitoring system approved in Australia (Fierce)


  • Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality System (Health Canada)
  • Canadian government invests in collaborative research tackling prescription drug abuse (PharmaLetter-$)

Zika Virus

  • Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks (FDA) (Focus) (NYTimes)
  • Brazil State Bans Pesticide After Zika Claim (WSJ-$)
  • WHO: $56 million to fight Zika outbreak. U.S.: $1.8 billion to combat Zika virus. (Washington Post)
  • Inovio says Zika vaccine shows response in mice (Reuters)
  • WHO: Countries must ramp up mosquito control measures to fight Zika (Washington Post)
  • Zika virus outbreak: Environment Committee debate with WHO on Wednesday (European Parliament)
  • Zika virus: Policy implications and practical considerations (Brookings)
  • With Zika Looming, What's It Like At A Maternity Clinic In Colombia? (NPR)

Other International

  • Celltrion expects to overcome Biogen bid to halt rituximab biosimilar locally (Fierce)
  • Global HPV vaccination provides greatest economic benefit to high income countries (Pharmaceutical Journal-$)

General Health & Other Interesting Articles

  • Immune Response to Flu Vaccine Linked to Recipients' Ethnic Background (ICT)
  • Doctors unsure if early childhood autism screening makes sense (Reuters)
  • There are always bacteria lurking in dental equipment, suggests research (MNT)
  • Online gamers beat supercomputers at RNA modeling (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.

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