Regulatory Focus™ > News Articles > Regulatory Recon: Theranos Under SEC, Criminal Investigation; India Formally Separates Drug and Devi

Regulatory Recon: Theranos Under SEC, Criminal Investigation India Formally Separates Drug and Device Rules (19 April 2016)

Posted 19 April 2016 | By Michael Mezher 

Regulatory Recon: Theranos Under SEC, Criminal Investigation India Formally Separates Drug and Device Rules (19 April 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

  • Progress Toward Stem Cell Treatment for Diabetes (NIH)
  • Dirty Devices Are Killing Patients. Can Congress Stop It? (Bloomberg)
  • Theranos Is Subject of Criminal Probe by US (WSJ-$) (Reuters)
  • Panel Would Make Insurers Help Contain Rising Drug Costs (NYTimes)
  • Muscular dystrophy drug advocates plan to pack crucial meeting (Boston Globe)
  • FDA approps: it's rider time (Politico)
  • Perhaps there is a drug that can prolong your life. It's called money (PLOS)
  • Grinding Up The Leaves and Roots (In the Pipeline)
  • Valeant CEO Deposed for at Least Nine Hours by Senate Committee (Bloomberg)
  • Final Guidance: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices (FDA)

In Focus: International

  • Indian Regulators to Formally Separate Medical Device and Pharmaceutical Rules (Emergo)
  • How the World Health Organization's cancer agency confuses consumers (Reuters)
  • Gene-editing research in human embryos gains momentum (Nature)
  • Roche 'very optimistic' on prospects for new cancer drugs (Financial Times)
  • Clouds gather over Novartis as it battles series of setbacks (Financial Times)
  • Evidence Generation – on the road to standardisation along the life-cycle of health technology (EUnetHTA)
  • China probes drugmakers over production methods (Reuters)
  • Uganda's only cancer treatment machine breaks, patients left waiting (Reuters)
  • Indian Drugmakers Target Niche Markets (WSJ-$)
  • WHO Director-General briefs UN on antimicrobial resistance (WHO)

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US: Pharmaceuticals & Biotechnology

  • NCI opens online platform to submit ideas about research for Cancer Moonshot (NIH)
  • Ready Or Not: Next Alzheimer's Drugs Might Strain Health Systems (Xconomy)
  • Patient Registries Prove Value As Drug Development Tools (SCRIP-$)
  • FDA Ends Niacin and Fenofibric Acid Combinations With Statins (CardioBrief)
  • Opioid Addiction: A Call to Action (Senator Blumenthal)
  • Form 483 Hits Specialty Drugmaker Over Adverse Event Reporting (FDANews-$)
  • Building a better biomedical knowledgebase (Outsourcing-Pharma)
  • Startup Aims to Revive Failed Drug (WSJ-$)
  • Rise in Oncologists Working for Hospitals Spurs Higher Chemo Costs: Study (Medpage)
  • Hope for Reversing Type 2 Diabetes (NYTimes)
  • Stigma keeps some cancer patients from getting palliative care (Reuters)
  • Watch your co-pays. Your pharmacy may be overcharging you. (Washington Post)
  • Public Citizen Study Shows Significant Reduction in Pharmaceutical Settlements 2014 – 2015 (Policy and Medicine) (Public Citizen)
  • A Basic Geometry Lesson - FDA's Off-label Losses (Policy and Medicine)
  • NIH launches research program to reduce health disparities in surgical outcomes (NIH)
  • The Importance of Applying Risk-based Design Control to Process Validation (GxP Lifeline)
  • Predictive biomarkers linked to cytokine release syndrome (BioCentury)
  • Ironwood CEO sees pay double, control strengthen as financial losses mount (Boston Business Journal)
  • A "Precedent-Setting" OTC Switch – And A Case Study In Disregarding FDA's Advice (RPM Report-$)

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

  • Pfizer Announces Positive Top-Line Results for Phase 3 PALOMA-2 Clinical Trial of IBRANCE (palbociclib) (Press)
  • Heron Therapeutics Provides Update on FDA Review of SUSTOL NDA (Press)
  • Jardiance (empagliflozin) to be studied for the treatment of people with chronic heart failure (Press)
  • Metformin lowers cardiac deaths better than other drugs (OnMedica)
  • ARCA biopharma Announces 75th Patient Enrolled in GENETIC-AF Phase 2B/3 Clinical Trial (Press)
  • Acucela Announces End of Treatment Period in Phase 2b/3 Clinical Trial of Emixustat Hydrochloride (Press)
  • Hansa Medical: Patient recruitment completed in Phase II clinical study with IdeS in kidney transplantation (Press)
  • Cerulean Announces Presentation at 2016 American Association for Cancer Research Annual Meeting of Stage 1 Data from Phase 2 Trial in Platinum-Resistant Ovarian Cancer (Press)
  • New Data Suggesting Positive Effects of Sanofi Genzyme's Lemtrada (alemtuzumab) on Brain Volume Loss and Retinal Nerve Fibers to be Presented at AAN (Press)
  • ZEMBRACE SymTouch (Sumatriptan Injection) 3 mg, Approved by the FDA in January 2016 for the Acute Treatment of Migraine with or without Aura in Adults, is Now Commercially Available in the U.S. (Press)
  • Avedro Receives FDA Approval for Photrexa Viscous, Photrexa and the KXL System for Corneal Cross-Linking (Press)

US: Medical Devices

  • Make Sure Process Validation Is Conducted By 'Qualified' Personnel, Experts Say (Gray Sheet-$)
  • Injured Patients' Attack on CDRH Chief Moves to Capitol Hill (MDDI)
  • ISO 13485 Tops List Of Latest Standards Out (Clinica-$)
  • Varian backs Phase III non-small cell lung cancer trial (MassDevice)
  • Special Controls Set By FDA For External Pacers, Analyzers (Gray Sheet-$) (Focus)
  • Sen. Durbin blasts Abbott over layoffs, separation agreement (MassDevice)
  • Nevro gets FDA pre-market approval for spinal cord stimulation device (MedCiityNews)
  • Class 1 Device Recall Boston Scientific Fetch 2 Aspiration Catheter (FDA)
  • New Sensor Detects Disease Biomarkers in Exhaled Breath (MedGadget)
  • First computer program developed to detect DNA mutations in single cancer cells (MNT)
  • GSK kicks off hand osteoarthritis trial (PharmaTimes)
  • Silk Road Medical Announces FDA 510(k) Clearance And First Patients Treated In the US with the Next Generation ENROUTE Transcarotid Neuroprotection System (MedDeviceOnline)
  • MammaPrint genetic test can reduce use of post-surgery chemotherapy among early-stage breast cancer patients (MNT)

US: Assorted & Government

  • Can 'Cures' be cured? (BioCentury)
  • Bill Calls for FDA to Require Advisory Panel for Non-Abuse Deterrent Opioids (Congress)
  • Senators Call on FDA to Finalize Tobacco Rule (Letter)
  • FDA Announces 2016 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs (FDA)
  • Obamacare's Striking Effect on America's Least Fortunate (NYTimes)
  • Spending Bill Pushes FDA Approval Of Drug Label Changes (Law360-$)
  • Court Dismisses Medical Device Claims That Named Many Defendants But Picked None Of Them
  •  (Drug and Device Law)
  • AbbVie As Patent Enemy: Suit vs. MedImmune Aims To Halt Humira Royalty (Pink Sheet-$)
  • NIST to release new standards for hospitals to increase cybersecurity (Fierce)
  • LGBT Backlash Legislation and the Politics of Biology (Harvard Bill of Health)
  • Drug Cos. Wants Chicago Opioid Suit Paused For FDA Results (Law360-$)
  • FDA Holding Public Meeting in Preparation for International Cooperation on Cosmetics Regulatory Meeting (FDA)
  • 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (HHS)
  • Why An Anthropologist, Not A Technologist Was The Best Choice For HHS CTO Role (Forbes)

Upcoming Meetings & Events

Europe

  • Germans Plan Petawatt Laser to Zap Brain Tumors (IEEE Spectrum)
  • How To Avoid Your Company Being 'Orphaned' During The Notified Body Redesignations (Clinca-$)
  • Joint Procurement Agreement - List of EU countries (EC)
  • Batch recall - Taxotere, Konzentrat zur parenteralen Anwendung Docetaxel Zentiva, Konzentrat zur parenteralen Anwendung (Co-Marketing-Präparat) (SwissMedic)
  • New Diabetes Device Wins CE Mark (MDDI)
  • EMA's Early Pediatric Advice Pilot Has Mixed Results (Pink Sheet-$)
  • LifeBond wins CE Mark, FDA fast track for LifeSeal surgical sealant (MassDevice)
  • Sanofi invests €300 mn to expand biologics site in Belgium (BioSpectrum) (Pharmafile)
  • The European Commission's Digital Plan is Much Needed for the Uptake of New Technologies in the Healthcare Sector (EFPIA)
  • Revised: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMA)

Asia

  • Bangladesh Market On Uptrend Amid Hep C Build-up (SCRIP-$)

India

  • Indian drug control weakest in the world, need to bolster it: Subburaj, Pharma Secretary (Economic Times)
  • India reflects on ramifications of joining Trans-Pacific Partnership (PharmaLetter-$)
  • Indian pharma to comply with track & trace technology as EMA mandates total adherence by April 2019
  •  (PharmaBiz)
  • India an FDC dumping ground: Additional Solicitor General Sanjay Jain (Economic Times)
  • Government working on recommendations to reduce bulk drug imports (Economic Times)
  • Alembic Pharma gets 4 USFDA observations for Panelav plant (Economic Times)
  • Drug haul: Avon Lifesciences denies any wrongdoings (Economic Times)

Australia

  • TGA approves combination treatment for PAH treatment (PharmaLetter-$)

Zika

  • CDC adds Belize to interim travel guidance related to Zika virus (CDC)
  • Bennet, Colleagues Call for Immediate Passage of Emergency Funding Request to Help Stem Spread of Zika Virus (Bennet)
  • Clinton aides traveling to Puerto Rico for Zika meetings (Reuters)

General Health & Other Interesting Articles

  • Poll: Are Unvaccinated Children a Public Health Hazard? (Medpage)
  • 'Nonurgent' patients might still end up being hospitalized (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 news@raps.org.

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


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