Regulatory Focus™ > News Articles > Regulatory Recon: WSJ Probes Theranos Over Edison System, Valeant Hit With Subpoena (15 October 2015

Regulatory Recon: WSJ Probes Theranos Over Edison System, Valeant Hit With Subpoena (15 October 2015)

Posted 15 October 2015 | By Michael Mezher 

Regulatory Recon: WSJ Probes Theranos Over Edison System, Valeant Hit With Subpoena (15 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

In Focus: International

  • Is it fair to accuse the pharma industry of neglecting tropical diseases? (The Guardian)
  • Kenya first country to launch 'Novartis Access', expanding affordable treatment options against chronic diseases (Pharmafile) (Novartis 1, 2)
  • Disparity in market prices for hepatitis C virus direct-acting drugs (The Lancet)
  • Japan's drug regulator PMDA set to open office in India (Economic Times)

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US: Pharmaceuticals and Biotechnology

  • The FDA Could Earn Over $60 Million A Day From Enforcing The Law (HealthAffairsBlog)
  • Advance Science, Don't Pressure US FDA On Approvals, Chief Tells Patient Advocates (SCRIP-$)
  • FDA Recruiting New CBER Director Ahead Of Gene, Cell Therapy Wave (RPM Report-$)
  • The self-regulation society? Consultant challenges manufacturing status quo (In-Pharma Technologist)
  • Galena Reinspection Finds AE Reporting Issues Unresolved (FDANews-$)
  • Priority Review Vouchers: Buyers Beware! (RPM Report-$)
  • Do fast drug approvals by FDA help or harm patients? (Lexology)
  • FDA declines to expand approval of Pfizer arthritis drug (Reuters) (Pfizer)
  • Advera: AbbVie's Viekira Pak riskier than Gilead's Harvoni for hep C (FiercePharma)
  • Ad Comms Update: An Overwhelming Day (Parent Project Muscular Dystrophy)
  • CDC and Opioids. Conflict? What Conflict? (DrugWonks)
  • Is This Cancer Treatment Worth It? New Tool Offers Patients Data (Bloomberg)

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

  • Lilly pill trumps Humira in arthritis study (Reuters)
  • GBT's sickle cell disease drug, GBT440 gets US FDA Fast Track designation (PharmaBiz)
  • Ampio Pharmaceuticals, Inc. Announces Updates On the Regulatory Path for FDA Approval of Optina™, an Oral Treatment for Diabetic Macular Edema (DME) (Press)
  • Cerulean Announces Completion of Enrollment of Randomized Phase 2 Trial of CRLX101 in Combination with Avastin® in Relapsed Renal Cell Carcinoma (Press)
  • Eleven Biotherapeutics Completes Enrollment in Pivotal Phase 3 Study of Isunakinra (EBI-005) in Patients with Allergic Conjunctivitis (Press)
  • Sarepta Therapeutics Announces Tentative FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy (Press)
  • BioDelivery Sciences Announces FDA Approval of Change in BUNAVAIL® Product Specification Allowing for Immediate Release of Product (Press)

US: Medical Devices

  • FDA's Bram Zuckerman On Benefit-Risk Assessments And Approaching FDA Early (Gray Sheet-$)
  • De Novo Cleared For Sonablate Device After Panel Rejects PMA (Gray Sheet-$)
  • Device Surveillance Reform Board Looks To Add Small-Firm Experience (Gray Sheet-$)
  • New US FDA Guidance for Medical Devices using Animal Studies (Emergo) (FDA)
  • St. Jude Warning Letter Spotlights CAPA Flaws At CardioMEMS Unit (Gray Sheet-$)
  • Avinger, Inc. Receives FDA 510(k) Clearance for Pantheris (Press)
  • Medtronic Drug-Coated Balloon Sustains Superiority Over Balloon Angioplasty at Two Years in Patients with Peripheral Arterial Disease (Medtronic)
  • Baxter wins FDA nod for Amia dialysis device (MassDevice)
  • Medtronic CoreValve® Evolut® R System Demonstrates Exceptional Results at One Year (Medtronic) (FierceMedicalDevices)
  • Intelesens gets FDA clearance for its Zensor wearable vital signs device (FierceMedicalDevices) (Intelesens)

US: Assorted and Government

  • Senator Klobuchar Calls on FTC To Investigate Pharma Companies for Antitrust Violations in Wake of Turing Case (Policy and Medicine)
  • 340B Orphan Drug Discounts Dialed Back (Law360-$)
  • Obesity drug developer hits $30K crowdfunding goal by slim margin (Philadelphia Business Journal)
  • Healthcare was barely a mention in the Democratic presidential debate (MedCityNews)
  • Amgen Can't Enforce Biosimilar Law, Hospira Says (Law360-$)
  • Abbott files suit over diverted diabetes test strips (Securing Industry)
  • Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015) (Patent Docs)
  • FDA Invests in Innovative Ways to Communicate to Hispanics (FDA Voice)

Upcoming Meetings and Events              

Europe

  • End-Of-Year Objective Set To Finalize EU Regulatory Trilogue Talks (Clinica-$)
  • Third French artificial heart patient 'doing well': Carmat executive (Reuters)
  • EMA Pilot For Early Advice On Pediatric Research Finally Gets Going (Pink Sheet-$)
  • Symbiosis confident injectables business will thrive under stricter MHRA (BioPharma-Reporter)
  • NHS England to relaunch its recommended health apps library as condition-focused "app stores" (MobiHealthNews)
  • CASI Pharmaceuticals Receives EU Orphan Drug Designation For The Use Of ENMD-2076 To Treat Hepatocellular Carcinoma Including Fibrolamellar Carcinoma (Press)
  • EMA grants Orphan Drug status to Can-Fite's liver cancer drug, CF102 (PharmaBiz)
  • Public consultation of Draft Assessment Report of the sixth pilot of WP5 Strand A: Rapid Relative Effectiveness Assessment of new pharmaceuticals for the treatment of chronic hepatitis C (EUnetHTA)

India

  • India risks missing boat as biosimilars shake up drug industry (Reuters)
  • Exporters demand withdrawal of barcode on pharma exports as thousands of SMEs stare at the prospects of closure (PharmaBiz)
  • Karnataka’s 27,000 chemists shut stores, KCDA submits memorandum to state health minister to ban all online pharmacy websites (PharmaBiz)
  • Nationwide pharma strike against e-pharmacy not affected West Bengal; AIOCD & AICDF members shut down their shops in Tamil Nadu (PharmaBiz)
  • Aurobindo Pharma gets US FDA nod for Alzheimer's drug Memantine Hydrochloride (Economic Times)
  • Beyond bird poop: FDA warns drug maker over disturbing record keeping (Pharmalot) (Economic Times) (Focus)
  • Jubilant Life gets USFDA nod for generic dementia tablets (Economic Times)
  • Indian drug retailers protest against e-pharmacies (Reuters)

Health Canada

  • Baxalta Gains Health Canada Approval for OBIZUR to Treat Patients with Acquired Hemophilia A (Press)

Australia

  • Australia Targets Patients And Doctors In Biosimilar Awareness Campaign (SCRIP-$)

Ebola Outbreak

Other International

  • Integrated addendum to ICH E6(R1) draft guideline for GCP receives favourable response from industry (PharmaBiz) (ICH E6(R2))

General Health and Other Interesting Articles

  • Blood test to monitor effectiveness of cancer treatments (OnMedica)
  • Antiviral Favipiravir Successfully Treats Lassa Virus in Guinea Pig Model (ICT)

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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