Regulatory Focus™ > News Articles > Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday; FDA Approves Va

Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday FDA Approves Valve-in-Valve Use for Edwards' Sapien 3 Valves (6 June 2017)

Posted 06 June 2017 | By Michael Mezher 

Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday FDA Approves Valve-in-Valve Use for Edwards' Sapien 3 Valves (6 June 2017)

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

In Focus: US

  • Drug Prices Become Target for FDA as Chief Expands Purview (Bloomberg)
  • Amgen SENSIPAR Pediatric Exclusivity Dispute is Put on Ice While FDA Dispute Resolution Process Proceeds (FDALawBlog)
  • FDA approves new use for Edwards' Sapien 3 heart valve (Reuters) (FDA)
  • ASCO Interviews (CNBC: Incyte, Merck, Roche, Bluebird, Loxo, BMS)
  • House E&C Committee to Vote on User Fee Reauthorization Wednesday (E&C)
  • 7 things doctors are buzzing about at the biggest cancer research meeting (Washington Post)
  • #ASCO17 need-to-know, all right here: Roche, BMS, Merck, Legend and more (Fierce)
  • Tiny Flex Pharma's CEO Westphal steps down (Fierce) (Boston Globe)
  • ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report (Focus)
  • FDA Delays UDI Requirements for Low-Risk Devices (Focus)
  • Prostate Cancer Drug About To Confront Insurers With Sovaldi-Size Problem (Forbes)
  • America's Hidden HIV Epidemic (NYTimes)
  • Promising New Cancer Drugs Won't Go Far Unless Everyone Gets Genetic Testing (MIT Technology Review)
  • AbbVie Testosterone Gel Faces Scrutiny as First Trial Begins (Bloomberg)
  • BMS, Novartis Plan Study to Test Opdivo and Yervoy with Mekinist for Colorectal Cancer (Press)
  • A Dilemma for Diabetes Patients: How Low to Push Blood Sugar, and How to Do It? (NYTimes)
  • For high blood pressure, combining drugs at lower dose may be effective (Washington Post)
  • AbbVie, Novo, Takeda take home honors in pharma's latest reputation study (Fierce)

In Focus: International

  • Israel's troubled Bioblast seeks partners, merger (Fierce)
  • NICE backs Allergan's Ozurdex, AbbVie's Humira for uveitis (PharmaTimes)
  • Netherlands to adopt medical devices anti-corruption legislation (MedicalDevicesLegal)
  • Roche Plunges After a Key Breast Cancer Treatment Trial Disappoints (The Street)
  • Novel Drug Movers and Shakers 2013-2016 (Pharmafile)
  • Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors (PLOS)
  • Dr. Babatunde Osotimehin, Global Advocate for Women's Health, Dies at 68 (NYTimes)
  • Lessons From Europe: Orphan Drug Valuations Show Limits Of Cost Effectiveness (Pink Sheet-$)

Pharmaceuticals & Biotechnology                                  

  • Moving the Needle on REMS Legislation (Morning Consult)
  • Researchers propose a roadmap to making custom medicines a reality (CNBC)
  • Women With Aggressive Breast Cancer Are Living Longer (NYTimes)
  • Big returns on small cancer research investment, study suggests (Reuters)
  • Reference Product Sample Abuses: Indian Firms Flag Concerns With FTC (Pink Sheet-$)
  • Orphan Drug Pricing Heading to Negotiating Table in US? (Pink Sheet-$)
  • Pfizer's $14B Medivation deal's now a cautionary M&A tale, thanks to ASCO: analyst (Fierce)
  • Lundbeck obtains rights to breakthrough research in Alzheimer's disease (PharmaLetter-$)
  • A start-up helping patients stay on top of their meds (CNBC)
  • A Peek at Partnering | AbbVie (BIO)
  • Asco – IO strategy in mesothelioma finally gets mapped out (EP Vantage)
  • 'Easy to work with' tops CRO benchmarking report (OutsourcingPharma)
  • Recipharm opens new GMP suite for clinical trial material (Pharmafile)
  • Tesaro's Zejula Expansion Includes Keytruda Combo, Lung Cancer (SCRIP-$)
  • Deficient DMFs Jeopardizing Timely Approvals of ANDAs (Pink Sheet-$)
  • Curbing Cancer Drug Costs: Lartruvo Vial Sizes Designed To Reduce Waste (Pink Sheet-$)
  • Lung Therapeutics breathes easy with $14M Series B (Fierce)
  • Zika Virus Hijacks Neurodevelopmental Protein To Replicate(BioCentury)
  • Facing Cash Crunch, Novan Slashes Staff and Shuffles Executive Team (Xconomy)
  • Eleven Biotherapeutics to Collaborate with AstraZeneca and the National Cancer Institute on Development of Vicinium in Combination with Durvalumab for the Treatment of Non-Muscle Invasive Bladder Cancer (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy (Press)
  • NewLink's IDO inhibitor score sheet reads one fail, one modest pass (Fierce)
  • ASCO: Dendreon touts T-cell response data for prostate cancer vaccine Provenge (Fierce)
  • NIAID-Sponsored Trial of Experimental Chikungunya Vaccine Begins (NIH)
  • Chi-Med touts fruquintinib's phase 3 safety edge in relapsed colorectal cancer (Fierce) (SCRIP-$)
  • Chi-Med Highlights Phase III Fruquintinib Data in Oral Presentation at ASCO (Press)
  • AstraZeneca Presents Tagrisso® (osimertinib) Data in Patients with EGFR T790M-Mutation Positive Lung Cancer and Central Nervous System Metastases (Press)
  • CVT-301 Phase 3 Data Showed Significantly Improved Motor Function During OFF Periods in Parkinson's Disease (Press)
  • FDA Approves Two-Month ARISTADA® for Treatment of Schizophrenia (Press)
  • NantKwest Expands NANT Cancer Vaccine Program With Additional Clinical Trials Announced Addressing Multiple Cancer Types Across All Stages of Disease (Press)
  • AntriaBio seeks FDA nod for trial of once-weekly insulin (Drug Delivery)

Medical Devices

  • Should CAPAs Be a Last Resort? (MDDI)
  • BD wins 510(k) for intestinal bacteria diagnostic (Drug Delivery) (GenomeWeb)
  • FDA Approves Roche's CMV Test (GenomeWeb)
  • 3D printing can give your medtech startup a competitive edge (Medical  Design & Outsourcing)
  • Roche receives FDA approval for CMV viral load testing on cobas® 6800/8800 Systems (Press)
  • QIAGEN receives U.S. FDA approval for cytomegalovirus (CMV) testing on automated QIAsymphony platform (Press)
  • Here's an example of product adoption with zero reimbursement (MedCityNews)
  • Miracor Announces Positive Interim Clinical Data with Novel PiCSO® Impulse System for AMI Patients (Press)
  • Endologix touts low rate of endoleaks, mortality in 2-year Nellix study results (MassDevice)
  • SentreHeart enters pivotal phase after hitting Lariat study milestone (MassDevice)

US: Assorted & Government

  • Trump advisers want president to do health care roadshow in June (Politico)
  • Puerto Rico declares Zika outbreak over, CDC maintains travel warning (Reuters)
  • Nevada governor vetoes bill that targeted diabetes drug costs (STAT)
  • The CBO's Updated Estimate Of The AHCA (Health Affairs Blog)
  • Teaching hospitals in U.S. are expensive, but have lower death rates (Washington Post)
  • Obamacare Didn't Destroy Insurance Markets, but It Also Didn't Fix Them (NYTimes)
  • Express Scripts, CVS Face ERISA Suit Over EpiPen Costs (Law360-$)

Upcoming Meetings & Events

Europe

  • Akebia prevails in two further European patent disputes (PharmaLetter-$)
  • New tool to help boost medical research and build closer relationships between pharma and academic researchers (ABPI)
  • French Pharma Industry Lays Out Wishlist For New Government, Proposes Five-Year Pact (Pink Sheet-$)
  • Preparation Plan For Europe's Unified Patent Court Delayed; UK General Election Spells More Uncertainty (Pink Sheet-$)
  • IQWiG assesses benefits of Cosentyx and Taltz (PharmaLetter-$)
  • Oxford Uni collaboration Scenic Biotech secures funding for its 'genetic off-switch' (Pharmafile)
  • Sanofi and Boehringer Ingelheim confirm closing of business swap date (EPR)
  • Medovex wins CE Mark for DenerveX spinal denervation system (MassDevice)
  • Boston Scientific wins CE Mark for Vercise Gevia DBS (MassDevice)

Asia

  • Orchard Therapeutics hits up Hitachi CDMO to make autologous gene therapy (BioPharmaReporter)

India

  • Vigilance officials raid 16 offices of Kerala state drug control offices, find major anomalies (PharmaBiz)
  • Skill development programme on pharmacovigilance conducted by IPC from Jan 2017 onwards gets overwhelming response (PharmaBiz)
  • IPC to hold workshop on 'Establishment of Pharmacovigilance System in Pharma Industries - A Way Forward' on June 23 at AIIMS, Rishikesh (PharmaBiz)
  • AICDF submits 3-pronged formula to NPPA to minimize confusion & loss to traders due to GST implementation (PharmaBiz)
  • Gujarat FDCA to tie up with NIPER Ahmedabad to train inspectors for detecting SAE of medical devices (PharmaBiz)

Other International

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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