Regulatory Focus™ > News Articles > Regulatory Recon: 23andMe to Once Again Give Users Health Data After 2013 Warning (21 October 2015)

Regulatory Recon: 23andMe to Once Again Give Users Health Data After 2013 Warning (21 October 2015)

Posted 21 October 2015 | By Michael Mezher 

Regulatory Recon: 23andMe to Once Again Give Users Health Data After 2013 Warning (21 October 2015)

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

  • Would Washington’s FDA Fix Cure the Patients or the Drug Industry? (ProPublica)
  • Ending the US government’s war on medical marijuana research (Brookings)
  • Should The Government Demand Rebates For Drugs With Roots In NIH Research? (Forbes)
  • A Look Back at Regulatory Enforcement by Therapeutic Category (Eye on FDA)
  • 23andMe Will Resume Giving Users Health Data (NYTimes) (AP) (More on 23andMe: Fast Company, Forbes)
  • Synta halts study of lung cancer treatment, stock plummets (Reuters)

In Focus: International

  • States could be sanctioned for public health failings: WHO boss (Reuters)
  • Oncology Benefits Most From EMA-FDA Pediatrics 'Cluster' Informal Advice (Pink Sheet-$)
  • What to Know about China's Fast Track Approval Process (MDDI)
  • Turkey Looks To Tackle Cancer As Deaths, Costs Rise (PharmAsiaNews-$)
  • This Is The Man In India Who Is Selling States Illegally Imported Execution Drugs (BuzzFeed)

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US: Pharmaceuticals and Biotechnology

  • FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder (FDA)
  • Valeant: Could this be the Pharmaceutical Enron? (Citron) (Bloomberg)
  • Compounder refuses to halt production despite FDA alert (Outsourcing-Pharma)
  • Are Placebos Getting Stronger? (Science Based Medicine)
  • Downing Labs, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to Lack of Sterility Assurance (FDA) (Dallas Morning News)
  • Open Payments: Research Payments Distorted by Including Value of the Medicines and Devices (Policy and Medicine)
  • Nearly 77 percent of pulmonary clinical trials failed to report race and ethnicity data (MNT)
  • Pertussis Booster In Every Pregnancy Safe For Mother And Child, Study Finds (Forbes)
  • New drug safety alliance launches to tout REMS benefits (DSN)
  • Drug Firms Stave Off Generics, Costing Consumers Billions, Critics Say (NBC News)
  • FDA Poised to Decide on Four NDAs This Week (FDANews-$)
  • Valeant Still Holding Off On DTC Ads For Controversial Female Sex Pill (Pink Sheet-$)

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

  • FDA OKs Topical Drug Combo (Enstilar) for Plaque Psoriasis (Medscape)
  • Eight-week data for Merck's triple HCV combo (BioCentury)
  • FDA approves Tris Pharma’s Dyanavel XR (DSN)
  • Stelara induces clinical remission in Crohn’s disease in Phase 3 trial (EuropeanPharmaceuticalReview)
  • Johnson & Johnson Battles Gilead for a Chunk of the Hepatitis C Market, Tries to Cut Treatment Time in Half (BioSpace)
  • Positive head-to-head results for GSK’s umeclidinium in COPD (EuropeanPharmaceuticalReview)
  • Biogen Reports Top-Line Results from Phase 3 Study Evaluating Natalizumab in Secondary Progressive MS (Press)

US: Medical Devices

  • Changing Your Manufacturing Site Location? Read This FDA Proposal (Gray Sheet-$) (Focus)
  • ‘Big Data’, Device Reprocessing Among FDA's Device Science Goals (Gray Sheet-$) (Focus)
  • MIT Team's Portal Instruments Developing Needle-Free Drug Delivery System (MedDeviceOnline)
  • Light Where the Sun Don't Shine (IEEE)
  • Two lefts make it right: Cardiac experts find novel approach to treat heart failure (MNT)
  • 3D Printed Titanium Sternum and Ribcage Implanted in Patient (medGadget)
  • TAVI: Direct Flow’s LeMaitre touts real-world data for next-gen heart valve (MassDevice)
  • OB-Tools TrueLabor FDA Cleared to Monitor Fetal Heart Rate (medGadget)
  • Collecting Reimbursement Data Alongside Clinical Data Is the Smart Road to Market (MDDI)
  • FDA Clearances Allow Implementation of 7-Day Platelets in the U.S. with the Platelet PGD Test (Press)
  • Qualcomm's Capsule Receives FDA Clearance of SmartLinx Vitals Plus™ (Press)

US: Assorted and Government

  • NEJM Study on Dietary Supplement Adverse Events Deserves Closer Scrutiny (FDA Law Blog)
  • Pharma flap imperils president’s trade deal (The Hill)
  • A Frye Opinion By Any Other Name: Zoloft Plaintiffs' Experts Excluded in Philadelphia (Drug and Device Law)
  • Sanofi's Kumar On Drug Pricing And US Election Rhetoric (SCRIP-$)
  • Amgen: Apotex Lost Bet; Biosimilar Should Be Blocked (SCRIP-$)
  • FDA Removes Pacira Warning Letter in Midst of Free Speech Suit (Policy and Medicine)
  • Issues Facing Life Sciences Cos. After EU-US Safe Harbor (Law360-$)
  • Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (FDA)
  • PTAB rejects Bass' Imbruvica challenge (BioCentury)
  • 'Enhanced' Patent Damages Under Supreme Court Review (SCRIP-$)
  • Ex-FDA boss McClellan to head Duke health policy center (BioCentury)
  • Cymbalta MDL Rejected Yet Again (Drug and Device Law) (Law360-$)
  • US Government Hit With Suit Over Vaccine Contract Payment (Law360-$)
  • Medtronic Cleared Of NuVasive Design Patent Claim (Law360-$)

Upcoming Meetings and Events              

Europe

  • New ISO 13485 Out In June 2016, Amidst Flood Of Updated EU Standards (Clinica-$)
  • EMA Wants Authority To Request Modifications To Agreed PIPs (SCRIP-$)
  • EU Regulation on Medical Devices still poses dangers to patients' interests, says ESHG (MNT)
  • EMA Announces Publication of Clinical Trial Reports By Middle of 2016 (Policy and Medicine)
  • Medtronic wins CE Mark for Visia AF single-chamber ICDs (MassDevice) (Medtronic)
  • NICE Plans To Support New Device To Improve Red Blood Cell Exchange In Sickle Cell Disease Management (MedDeviceOnline)
  • IQWiG finds added benefit for Opdivo in certain patients (PharmaLetter-$)
  • England’s NICE backs Merck & Co’s Ezetrol for primary hypercholesterolemia (PharmaLetter-$)

India

  • DoP to come out with a revised UCPMP code for pharma cos (PharmaBiz)
  • DoP rules in favour of Abbott India on revision of prices of ibuprofen 200 mg & 400 mg tablets (PharmaBiz)

Japan

  • Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial (The Lancet) (Eisai)

China

  • Chinese hospitals may have to charge patients more due to underfunding of government's reform plan (SCMP)
  • Chinese Hackers Target Pharma Trade Secrets (PharmAsiaNews-$)

Australia

  • Hazard Alert - VAIOS Total Shoulder Replacement System (TGA)

Other International

  • NIH Study Reveals Risk of Drug-Resistant Malaria Spreading to Africa (ICT)
  • US, Korea Join Hands On Precision Meds, MERS Vaccines (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • NIH Scientists Create Two-Headed Protein to Deplete HIV Reservoir (ICT)
  • Two Vaccines for One Polio-free World (CDC)
  • American Cancer Society, in a Shift, Recommends Fewer Mammograms (NYTimes) (Washington Post)
  • Superbug Infection Greatest Increase in Children Ages 1-5 (DD&D)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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