Regulatory Focus™ > News Articles > Regulatory Recon: Court Clears Sanofi, Regeneron to Sell Praluent During Appeal; Xarelto Trial Stopp

Regulatory Recon: Court Clears Sanofi, Regeneron to Sell Praluent During Appeal Xarelto Trial Stopped Early (9 February 2017)

Posted 09 February 2017 | By Michael Mezher 

Regulatory Recon: Court Clears Sanofi, Regeneron to Sell Praluent During Appeal Xarelto Trial Stopped Early (9 February 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Regeneron, Sanofi win stay of US order blocking cholesterol drug sales (Reuters) (STAT) (Endpoints) (WSJ) (SNL) (Press)
  • Enormous Rivaroxaban Study Stopped Early For 'Overwhelming Efficacy' (CardioBrief) (PharmaTimes) (Pharmafile) (Reuters) (MedScape) (Press)
  • Acorda Parkinson's trial hits endpoint, teeing up FDA filing (Fierce) (The Street) (Endpoints) (Press)
  • GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators (Focus) (NYTimes)
  • Tetraphase antibiotic may reach up to $700 million in annual sales: CEO (Reuters)
  • Lawmakers demand info on opioid overdose antidote after a big price hike (STAT)
  • Democrats Question Acting Secretaries of Health, Treasury and Labor on Trump ACA Order (Letter)
  • Public Citizen Petitions FDA to Pull Some IV Solutions (Focus)
  • Amid Reports of Infant Deaths, FTC Cracks Down on Homeopathy While FDA Investigates (JAMA)
  • Obama's Drug Czar: The Opioid Crisis Must Continue To Be A Federal Priority (KHN)
  • New Questions Raised About SPRINT (CardioBrief)
  • New Data In The FDA Deregulation Debate (Forbes)
  • How to Start Lowering Drug Prices Now (Morning Consult)
  • Amid flurry of new cancer drugs, how many offer real benefits? (CNN)
  • Industry Group Links More Than 28,000 Job Losses to Device Tax (Focus)
  • Dying Patients Have Pence's Backing on 'Right to Try' Policy (Bloomberg)
  • Pharma scrambling on right-to-try (BioCentury)
  • Report Cites Deficiencies at Theranos Lab (WSJ)
  • Obamacare repeal-replace effort begins to come together (Politico)
  • Gilead's Boom Fades and Bust Will Linger (WSJ) (SCRIP-$) (The Street)
  • GlaxoSmithKline and Gilead to face off at HIV meeting next week (Reuters)

In Focus: International

  • MHRA Launches New Blog on Medicines Regulation (MHRA)
  • Ipsen Names New Head of Global Medical Affairs, Head of Specialty Care (Pharmafile 1, 2)
  • European Commission Report on Cancer Screening (EC)
  • CFDA issues Provisions for Medical Device Recall (CFDA)
  • CFDA issues Amendment to the Provisions for In-vitro Diagnostic Reagent Registration (CFDA)
  • GSK beats forecasts but braces for asthma drug challenge (Financial Times) (The Guardian) (PharmaTimes)
  • ICH Offers Updates on New Members, Progress on Guidelines (Focus)
  • MRC joins forces with GSK and the South African MRC to tackle NCDs in Africa (MRC)
  • Top five European countries by pharmaceutical spending per capita (Pharmafile)
  • China Options For Takeda As It Pursues Emerging Markets Buy (SCRIP-$)
  • Grand challenges for the next decade in global health policy and programmes  (WHO)
  • Two Phase 3 failures put nail in the coffin for Lundbeck Alzheimer's drug (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Allergan Tops Fourth Quarter Revenue Forecast (The Street)
  • Podcast: FDA's Leah Christl Talks Biosimilars (Pink Sheet-$)
  • Anesthesia and Developing Brains — Implications of the FDA Warning (NEJM)
  • Just say no to drug ads on TV (Washington Times)
  • Sanofi: Plant problem that concerned FDA is fixed (Market Watch)
  • Tesaro rises on takeout rumors (BioCentury)
  • The problem with neoantigen prediction (Nature)
  • Common Rule Revisions: Impact of Public Comment, and What's Next? (Hastings Center)
  • Designer compound may untangle damage leading to some dementias (NIH)
  • Portola: FDA won't require betrixaban meeting (BioCentury)
  • Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter (FDA)
  • Not All Antibiotic Overuse Interventions Are Created Equal (Forbes) (Study)
  • Using FAERS Data and Clinical Evidence to Compare HER2+ Antagonists (RxView)
  • Why your doctor's advice to take all your antibiotics may be wrong (STAT)
  • Best Practices for Communication Between FDA and IND Sponsors During Drug Development (BIO)
  • Hair analysis may help diagnose Cushing Syndrome, NIH researchers report (NIH)
  • Ovid, NeuroPointDX team up on rare disease trial (Fierce)

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

  • Arms Pharmaceutical touts oral spray for upper respiratory tract infections (Drug Delivery)
  • Ignyta's Updated Phase 1 Data on Safety, Anti-Tumor Activity and CNS Activity of Entrectinib in Cancers with TRK, ROS1 or ALK Fusions Published in Cancer Discovery (Press)

US: Medical Devices

  • This Technology Could Finally Make Brain Implants Practical (MIT Technology Review)
  • Baxter backs Medtech Innovator (MassDevice)
  • CareFusion Recalls Alaris Syringe Pump due to an Alarm Error Which May Cause Interruption of Therapy (FDA)
  • Smith & Nephew misses the mark with 2016 results (MassDevice)
  • US Dept of Homeland Security updates on St Jude's Merlin@home vulnerabilities (MassDevice)
  • ICU Medical closes $900m buyout of Pfizer's Hospira infusion pump biz (MassDevice)
  • Recent Improvements in Coatings for Intravascular Devices (MDDI)
  • Mercator MedSystems touts data for Bullfrog microinfusion device (MassDevice)

US: Assorted & Government

  • Wyden Speaks on Senate Floor in Opposition of Tom Price's Nomination to Lead HHS (Senate Finance)
  • Trying to Untie the Gordian Knot: New Attempts to Change Federal Law on Marijuana (FDA Law Blog)
  • Federal Judge Blocks Anthem's Planned Acquisition of Cigna (WSJ) (Reuters) (DoJ)
  • FTC Approves Final Order with Parent Company of Bausch + Lomb (FTC)
  • Medicaid Managed Care: Improved Oversight Needed of Payment Rates for Long-Term Services and Supports (GAO)
  • Unreliable Expert Causation Evidence Ends Birth Defect Case (Drug & Device Law)
  • Humana Delays 2017 Outlook Amid Review Of Judge's Aetna Ruling (Forbes)

Upcoming Meetings & Events

Europe

  • Zimmer Biomet wins CE Mark for Subchondroplasty bone marrow lesion procedure (MassDevice)
  • Novo Nordisk backs Denmark's bid to host EMA post-Brexit (Fierce)

Asia

  • South Korea raises foot-and-mouth disease alert status to highest level (Reuters)
  • Accuray wins Japanese regulatory nod for Radixact platform (MassDevice)
  • First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies (Press)

India

  • Only 3,016 clinical studies being done in India out of 2,36,329 clinical studies globally (PharmaBiz)
  • Hetero Drugs exploring in biosimlars; to launch more products on commercial scale soon (PharmaBiz)
  • MNC pharma lobby pushes for single drug authority here (Economic Times)
  • Pharma SMEs in Karnataka look to upgrade units to global standards to move up value chain (PharmaBiz)
  • DoP rejects review application filed by FDC against price fixation of "Metformin (1000 mg), flunarizine, ramipril etc" (PharmaBiz)

Australia

  • MRA GMP clearance application processing timelines (TGA)

Canada

  • Summary Safety Review - Low-Molecular-Weight Heparins - Assessing the potential risk of bleeding in or around the spinal cord (Spinal/Epidural Hematoma) (Health Canada)

Other International

  • Eight countries sign up to counter Trump's global anti-abortion move (Reuters)

General Health & Other Interesting Articles

  • Cool Videos: Looking Inside Living Cells (NIH)
  • Dense breasts may be leading risk factor for breast cancer (Reuters)
  • Antibiotic-resistance being spread from flies to people (Pharmafile)

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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