Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Cautiously Backs Acadia Parkinson's Drug, NICE Looks for New Ways to Pay

Regulatory Recon: FDA Panel Cautiously Backs Acadia Parkinson's Drug, NICE Looks for New Ways to Pay for Cell Therapies (30 March 2016)

Posted 30 March 2016 | By Michael Mezher 

Regulatory Recon: FDA Panel Cautiously Backs Acadia Parkinson's Drug, NICE Looks for New Ways to Pay for Cell Therapies (30 March 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

  • FDA panel backs Acadia drug for psychosis linked to Parkinson's (Reuters) (SCRIP-$) (Pink Sheet-$) (WSJ-$) (Tarius) (Press)
  • Bernie Sanders' Bad Medicine for Drug Prices (Bloomberg)
  • Springtime in DC Means Mosquitoes - And Zika (Foreign Policy)
  • Obama Expands Buprenrphine, Naloxone Use to Fight Opioid Epidemic (Focus) (PharmaLetter-$)
  • The price of health: the cost of developing new medicines (The Guardian)
  • Medical Device Hackers Now Deemed Allies By FDA, Industry (Gray Sheet 1, 2-$)
  • Newest Policyholders Under Health Law Are Sicker and Costlier to Insurers (NYTimes) (WSJ-$) (Forbes)
  • Only Two Out of Ten Drugs? Really? (In The Pipeline)
  • Shire Gives CEO 422% Pay Boost to Allay Defection Concerns (Bloomberg)
  • Anthony Fauci on Mosquitos: Kill Them (STAT)
  • The great mosquito debate: Keep them (STAT)

In Focus: International

  • Emergency Over Ebola Has Ended, WHO Says (NYTimes) (WHO)
  • Baby's Death Shows Global Threat From Wonder Drug's Demise (Bloomberg)
  • Facing further price cuts, Chinese companies look to diversification (In-PharmaTechnologist)
  • Chinese Market Offers New Life to Many Drugs (WSJ-$)
  • NICE eyes alternative payment models for cell therapies (BioCentury) (PharmaPhorum)
  • Superbugs and Superdrugs, Pushing Financial Incentives and Collaborative Incentives to Accelerate Clinical Success (LifeSciencesConnect)
  • Ecuador is first country to use mobile devices to measure risk factors for noncommunicable diseases (PAHO)

US: Pharmaceuticals & Biotechnology

  • Gleevec: A Successful Life and Impact of Generics (LifeSciencesConnect)
  • Analysts: Xtandi March-In Demands 'Noise,' 'Misguided' (SCRIP-$)
  • Valeant's Accounting Error a Warning Sign of Bigger Problems (NYTimes)
  • ValueAct Pays a Price for Its Supporting Role at Valeant (NYTimes)
  • Explaining Valeant: The Main Theories (NYTimes)
  • Is FDA Biosimilar Regulatory Process Defeating Purpose Of BPCIA? (BioProcessOnline)
  • TREND: Rare disease, cancer drugs will drive pharma M&A's, growth (Pharmafile)
  • Sandoz disputes AbbVie's interchangeability argument (BioCentury)
  • Create Pharmaceutical Commercial Boards To Meeting Developing Brand Needs (Cutting Edge Info)
  • Puma slips on neratinib NDA delay (BioCentury)
  • Cycle For Survival Is Both Hope-Raiser And Fund-Raiser In The Fight Against Rare Cancers (Forbes)
  • Are stem-cell therapies for parkinson's disease ready for clinical trials? (MNT)
  • Cancer And The Presidency: Why This CEO Says Each Candidate Needs A Plan (Forbes)
  • Gliptin Game May Get More Crowded in 2016 (MedpageToday)
  • B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Injection USP in PAB Container Due to Leakage and/or Particulate Matter Identified To Be Microbial Growth (FDA)
  • The Xconversation: Vaccine Developer Meets Energy Innovator, Part II (Xconomy)
  • With New Execs, Sanofi Backing, ImmuneXcite Begins Clinical Push (Xconomy)
  • How Did Martin Shkreli Ever Become A Pharmaceutical CEO? (Forbes)
  • GSK Reaffirms Its Commitment To Oncology Research But The Strategy Is Unclear (Forbes)
  • New Drug Combinations Could Significantly Improve Tuberculosis Treatment (ICT)
  • Stockwatch: Natural History Confounds Surrogate Endpoints (SCRIP-$)
  • One New Request Pharmaceutical Manufacturers Are Asking For (BioProcessOnline)

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

  • Newron Receives Complete Response Letter from US FDA for Xadago (safinamide) (Press) (BioCentury)
  • Bristol-Myers Squibb and Pfizer Announce Global Real-World Data Program and Present New Analyses of Eliquis (apixaban) at the American College of Cardiology's 65th Annual Scientific Session (Press)
  • Sanofi And Regeneron To Present Phase 3 Praluent (Alirocumab) Injection Clinical Trial Data At ACC.16 (Press)
  • Keryx says anemia drug succeeds in study of kidney patients (Reuters)
  • FDA Approves sNDA for Boehringer Ingelheim's COPD Drug (DD&D)
  • OPKO Receives Complete Response Letter from FDA for RAYALDEE New Drug Application (Press)
  • Phase III enzalutamide trial initiated in mHSPC (EPR)
  • SpinalCyte, LLC Announces New Results from Phase II Animal Trials of Cell Therapy to Regenerate the Spinal Disc (Press)
  • Tokai Announces Dosing of First Patient in Phase 2 Expansion Study of Galeterone in Enzalutamide-Refractory mCRPC Patients (Press)
  • Merck to Present New Findings from Chronic Hepatitis C Clinical Development Programs at The International Liver Congress 2016 (Press)
  • Bristol-Myers Squibb and Pfizer Announce Global Real-World Data Program and Present New Analyses of Eliquis (apixaban) at the American College of Cardiology's 65th Annual Scientific Session (Press)

US: Medical Devices

  • 3 Steps To Prepare For FDA's Final Quality Metrics Guidance (BioProcessOnline)
  • US FDA Expands UDI Training Resources for Medical Device Companies (Emergo) (FDA)
  • Cases continue against Bayer's Essure birth control device, based on a ruling from a federal judge (MedCityNews)
  • ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit (GxP Lifeline)
  • Automated Ebola blood test performs well in field evaluation (MNT)
  • Philips Inks $77 Million Medical Equipment Deal With U.S. Defense Department (MedDeviceOnline)
  • FDA clears Corindus Vascular Robotics CorPath for peripheral interventions (MassDevice)
  • Labeling, Packaging Front-And-Center As Unique Device Identifiers Move Forward, Survey Shows (Gray Sheet-$)
  • Study results: cost savings associated with robotic-assisted laparoscopic prostatectomy (MNT)
  • Precision Biopsy Submits Investigational Device Exemption (IDE) Application to the FDA to Expand Clinical Trial of Its ClariCore™ Biopsy System in Prostate Cancer Patients (Press)
  • Tenex Health wins 510(k) for TX2 MicroTip (MassDevice)

US: Assorted & Government

  • FDA Warns Shower Product Company Over Bacterial Contamination (FDA)
  • First Circuit Upholds Defense Verdict in Diet Drug Case (Drug and Device Law)
  • Medicare Advantage Makes It Easier For People To Achieve Their Best Health (Forbes)
  • Court seeks new way to decide birth-control cases (SCOTUS Blog) (Reuters) (Harvard Bill of Health)
  • Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse (National Law Review)
  • US DOJ Expands Investigation Into Phony Novartis Speaking Events (CardioBrief)
  • FTC backs provision advancing telemedicine services in Alaska (Fierce)
  • Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary Burwell (FDA Law Blog)
  • EMED seeks injunction against ReproMed (MassDevice)
  • Some Good Georgian Res Judicata (Drug and Device Law)
  • Feds Still Investigating Whether Biomet Broke Rules Abroad (Law360-$)
  • Pharma Groups Back Pfizer In 3rd Circ. Pay-For-Delay Case (Law360-$)
  • FDA and Health Canada announce first simultaneous review and approval of a veterinary drug for food-producing animals (FDA)

Upcoming Meetings & Events

Europe

  • Labeling Changes Possible For HCV Direct-Acting Antivirals As EMA Probes HBV Reactivation (SCRIP-$)
  • Debt-ridden NHS trusts face £600m in fines this year (OnMedica)
  • Life sciences strength will drive UK pharma sector growth (Pharmafile)
  • Retina Implant wins CE Mark for next-gen blindness implant (MassDevice)
  • St. Jude wins CE Mark for expanded suite of cardiac leads (MassDevice)

Asia

  • Sun Enters Japan Through Divested Novartis Portfolio (SCRIP-$) (BioSpectrum
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  • GSK receives marketing authorization for Nucala in Japan (BioSpectrum)
  • Indonesia pushes to unshackle victims of mental illness (Reuters)
  • After China vaccine scare, Hong Kong to limit inoculations for non-resident children (Reuters)

India

  • Indian plans to develop biotechnology sector (PharmaLetter-$)
  • Lupin gets 3 observations from USFDA for Mandideep plant (Economic Times)
  • Aurobindo Pharma gets USFDA nod for antibiotic drug (Economic Times)
  • Antibiotic resistance in India alarming but not shocking as US: Dr BV Ravi Kumar (PharmaBiz)
  • New ayurvedic drugs to face tough clinical trials (Economic Times)

Canada

  • Don't screen all kids for developmental delays, Canadians say (Reuters)

Australia

  • New Australian recommendations for Hep C management (MNT)
  • Medical Devices: how to stay included (TGA)

Zika

  • WHO Drafts 'Desired Characteristics' For Zika Virus Diagnostics (SCRIP-$)
  • Brazil's confirmed, suspected microcephaly cases rise to 5,235 (Reuters)

Other International

  • Giant rats to sniff out tuberculosis in Tanzania, Mozambique prisons (Reuters)
  • U.S. firms target investment in Israeli cannabis R&D (Reuters)

General Health & Other Interesting Articles

  • Painful uterus condition may boost risk for heart disease (Reuters)
  • Student-built exoskeleton mimics human knee (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.


Categories: Recon, Regulatory News

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