Regulatory Focus™ > News Articles > Regulatory Recon: Heart Failure Experts Criticize Clinical Trials & Guidelines; Novartis Settles

Regulatory Recon: Heart Failure Experts Criticize Clinical Trials & Guidelines Novartis Settles China Bribery Charges (24 March 2016)

Posted 24 March 2016 | By Michael Mezher 

Regulatory Recon: Heart Failure Experts Criticize Clinical Trials & Guidelines Novartis Settles China Bribery Charges (24 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

  • Stryker is offering a $5M guarantee for its surgical sponges (MedCityNews)
  • The Dream Team That Could Fix Drug Pricing (Part 2) (Forbes)
  • Use of Open Access Platforms for Clinical Trial Data (JAMA)
  • Top HF Expert Decries 'Unbelievable Folly' of Clinical Trials and Guidelines (CardioBrief)
  • We're More Honest With Our Phones Than With Our Doctors (NYTimes)
  • Justices Seem Split in Case on Birth Control Mandate (NYTimes)
  • Court Decision In Patent Battle Threatens PCSK9 Drug (CardioBrief)
  • FDA warns Terumo over vascular sheath (MassDevice)

In Focus: International

  • Novartis agrees to $25m settlement over bribery charges in China (STAT) (Bloomberg) (Law360-$) (Policy and Medicine)
  • Valeant Jacks Up Cost Of Aid-In-Dying Medication (NPR)
  • China says vaccine scandal suspect was free to re-offend (Reuters)
  • Brazil's BNDES provides $136 million to fight Zika, related illnesses (Reuters)
  • Russian government may introduce state monopoly on drugs production (PharmaLetter-$)
  • Pharmacy dispensing models and displaying prices on medicines (MHRA)
  • WHO Director-General addresses high-level conference on global health security (WHO)

US: Pharmaceuticals & Biotechnology

  • Xbox Kinect Tech Harnessed To Monitor Cystic Fibrosis, Other Lung Diseases (Forbes)
  • Billionaire Allen Gives $100 Million for Bioscience Research (Bloomberg)
  • Tuberculosis Study Launched, Powered By Citizen Scientists on IBM's World Community Grid (IBM)
  • Collaboration With Chronic Disease Groups Optimizes Outcomes For Payers And Patients (Health Affairs Blog)
  • The Fight Of A Lifetime: Health Systems And Chronic Diseases (Health Affairs Blog)
  • Is The High Cost Of Drugs To Offset R&D Expenses Justified? (Forbes)
  • Creative Minds: Complex Solutions to Inflammation (NIH)
  • Pediatric Applicability or Not–This Revised Guidance Is for You (The 505(b)(2) Blog)
  • Biotech Roars Back On Forbes' List Of The Top Venture Capitalists (Forbes)
  • FDA Orders New Warnings For Opioid Pain Drug Labels, But Whether They'll Have Much Effect Isn't Clear (Forbes)
  • Got Your Tetanus Shot? You May Not Need Another For 30 More Years (Fobres)
  • A Leukemia Drug Takes On Head and Neck Cancers (Geeks Talk Clinical)
  • Novasep aims to fast-track mAb process development in GTP partnership (BioPharma-Reporter)
  • Reflections On An Atlas-Backed Startup Exit: Padlock Therapeutics Hands Keys To BMS (Forbes) (SCRIP-$) (Press)
  • Opioids And The Limits Of US FDA's Authority (SCRIP-$)
  • Drug firms should share more data says environmental researcher (In-PharmaTechnologist)

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

  • Cytori Update on Its U.S. Phase III Scleroderma Trial (Press)
  • Praluent reduces need for apheresis in HeFH patients (BioCentury) (MNT)
  • Ironwood Pharmaceuticals Initiates Phase IIb Clinical Trial of IW-3718 in Refractory Gastroesophageal Reflux Disease (Press)
  • LCT Starts Phase IIb Clinical Trial of NTCELL for Parkinson's Disease (Press)

US: Medical Devices

  • AdvaMed Tells US FDA Which Guidelines Need To Be Finalized First (SCRIP-$)
  • Genetic test aims to improve diabetes diagnosis (Reuters)
  • Great Basin STEC Test Gets FDA 510(k) Clearance (GenomeWeb)
  • Intersect ENT wins expanded FDA approval for Propel Mini (MassDevice) (Press)
  • FDA OKs improved MarginProbe device from Dune Medical (MassDevice)
  • ACell wins 510(k) for modified MicroMatrix (MassDevice)
  • Xeltis wins FDA nod for bioresorbable pulmonary valve (MassDevice)
  • FDA clears Stimwave's StimQ wireless chronic pain stimulator (MassDevice)
  • Opsens OptoWire II for Fractional Flow Reserve Measurement FDA Cleared (MedGadget)
  • Carestream Submits Application for FDA 510(k) Clearance For Its OnSight 3D Extremity System (Press)

US: Assorted & Government

  • The Expansive Impact Of Acorda On Hatch-Waxman Cases (Law360-$)
  • U.S. bill targets babies born dependent on opioids (Reuters)
  • HEALTHCARE.GOV: Actions Needed to Enhance Information Security and Privacy Controls (GAO)
  • Respironics to settle U.S. kickback charges for $34.8 million (Reuters) (DoJ)
  • Tax exemptions and nonprofit hospitals: An uncertain future (Harvard Bill of Health)
  • Trial kicks off in 10-year-old Abbott stent case (MassDevice)
  • CRISPR Interference Motions Set (Patent Docs)
  • Amgen: Zarxio Lawsuit 'Poor Vehicle' To Interpret BPCIA (SCRIP-$) (Pink Sheet-$)
  • Gilead Seeks To Limit Sovaldi/Harvoni Royalties In Wake Of Merck's Patent Victory (Pink Sheet-$)
  • Courts Have Nothing But Good Things To Say About Predictive Coding (Drug and Device Law)
  • Potent Synthetic Drug Exacerbates Heroin Epidemic in New York City (WSJ-$)

Upcoming Meetings & Events

Europe

  • Meeting of the Competent Authorities on Blood and Blood Components  (European Commission)
  • EC Rare Disease Newsletter (European Commission)
  • Antibiotic prescribing falls in general practice (OnMedica)
  • Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (EMA)
  • Baxter Completes CE Mark for Expanded Indication of HEMOPATCH, an Innovative Surgical Patch, In European Union (Press)
  • Pfizer Announces European Medicines Agency Accepted for Review Its Marketing Authorization Application for XELJANZ® (Tofacitinib Citrate) for the Treatment of Moderate to Severe Rheumatoid Arthritis (Press)

Asia

India

  • Janssen India Boss On Sirturo's Pricing Stand And Real World Evidence (SCRIP-$)
  • Will retire from Chairmanship of Sanofi India: Vijay Mallya (Economic Times)
  • Gland Pharma Preparing Generic Of Eagle Pharma's Bendeka (24 Insight)

Canada

  • Canadian Prime Minister Calls for C$237.2M Investment in Genome Canada (GenomeWeb)
  • Health Canada accepts for review Raptor's Procysbi NDA to treat nephropathic cystinosis (PharmaBiz)

Australia

  • Review of the efficacy and safety of over-the-counter codeine combination medicines (TGA 1, 2)

Zika

  • Congress just went on spring break without voting on emergency Zika measure (STAT)

Other International

  • Easy-To-Use IUD Inserter Could Aid Women Who Lack Access To Birth Control (NPR)

General Health & Other Interesting Articles

  • Better inhaler lessons can prevent asthma emergencies (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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