Regulatory Focus™ > News Articles > Regulatory Recon: Novartis Plans Massive Clinical Program for Entresto; NICE Rejects Roche Breast Ca

Regulatory Recon: Novartis Plans Massive Clinical Program for Entresto NICE Rejects Roche Breast Cancer Drug (20 May 2016)

Posted 20 May 2016 | By Michael Mezher 

Regulatory Recon: Novartis Plans Massive Clinical Program for Entresto NICE Rejects Roche Breast Cancer Drug (20 May 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

  • From Competition to Collaboration: precisionFDA Challenges (FDA Voice)
  • FDA Considering Pricey Implant As Treatment For Opioid Addiction (NPR)
  • Myriad hit with complaint over access to genetic information (Reuters) (GenomeWeb)
  • Theranos plans bold expansion even as it reels from new setbacks (STAT)
  • Theranos' Last Defense Crumbles (Forbes)
  • FDA Delays Rule on Generic Drug Labels (NYTimes) (STAT) (Focus)
  • Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug (CardioBrief) (Reuters) (Press)
  • Senate approves $1.1 billion to fight Zika virus (Reuters)

In Focus: International

  • China slashes GSK, AstraZeneca drug prices in cost-cutting drive (Reuters)
  • Roche breast cancer drug Perjeta rejected by UK cost agency (Reuters)
  • Bayer chief picks contentious path for growth with Monsanto bid (Financial Times) (NYTimes)
  • European Regulatory Roundup: EMA Offers Draft Proposal on Dissolution of Generics (Focus)
  • EMA Ready To End Adaptive Pathways Pilot, Tap Into Lessons Learned (Pink Sheet-$)
  • Report Calls for Stakeholders to Pull Together to Fight Superbugs, Big Pharma Balks at Proposed Tax (Financial Times 1, 2)
  • Life expectancy increased by 5 years since 2000, but health inequalities persist (WHO)
  • Indian pharma company may sue drug controller over safety of Novartis painkiller (Economic Times)
  • WHO's Medtech Model Framework Encourages Reliance On 'Trusted Regulators' (SCRIP-$)

Drug Approval - Speed your time to market with FDA's Expedited Programs

US: Pharmaceuticals & Biotechnology

  • Telemedicine regulatory policy advancing slowly but surely (watch) (MedCityNews)
  • FDA More Than Doubles the Number of Orphan Drug Designation Revocations Overnight (FDA Law Blog)
  • FDA Revises Draft Guidance on COPD Drug Development (Focus)
  • Embrace preprints and set biomedical information free (STAT)
  • Patient-Driven Research Will Lead To Better Health (Health Affairs Blog)
  • In reversal, Braeburn Pharma will stay in NC despite controversial law (BioPharmaDive)
  • Why a drug that lowers cholesterol doesn't save lives (STAT)
  • Congressmen Question FDA Over Office of Laboratory Safety (Focus)
  • Valeant Shares Under Pressure as Wells Fargo Cuts Estimates (The Street)
  • The NIH Needs To Increase Efforts To Fight Drug Resistant Bacteria (Forbes)
  • Senator Durbin Asks Medical Associations to Endorse Mandatory Opioid CME – AMA Shows Interest (Policy and Medicine)
  • Clinical Trials Day: focusing on awareness, the 'war on talent,' and an industry-wide commitment (Outsourcing-Pharma)
  • Industry criticizes FDA's proposed DTC studies (MM&M)
  • US ANDA Approvals Soar, But Does FDA Need To Do More? (PharmasiaNews-$)
  • ASCO Puts A Spotlight On CDK4/6 Category Ahead Of New Competition (Pink Sheet-$)
  • New technique creates 'nearly pure drug' for injection (In-PharmaTechnologist)
  • Gardasil Faces Another Safety Study, Looking At Four Rare AEs (Pink Sheet-$)
  • FDA Updates Safety Communication for Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues -  linked to patient death (FDA)
  • SACHRP: FDA Should Revise Informed Consent Waivers to Match HHS Rules (FDANews-$)
  • New US Compassionate Use Tool Would Need Support Of Drug Makers (SCRIP-$)
  • Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method (BioPharma-Reporter)
  • Opinion: The FDA should approve the first disease-modifying treatment for Duchenne Muscular Dystrophy (The Hill)

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

  • FDA grants 'Breakthrough' status for Celator's blood cancer drug (Fierce)
  • Mundipharma releases 2-year Remsima efficacy data (BioPharma-Reporter)

US: Medical Devices

  • Senate Seeks Performance Data From FDA On De Novos, Postmarket Surveillance (Gray Sheet-$)
  • Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (FDA)
  • MDUFA Negotiations Mellow Out Over Opposing Wish Lists (Gray Sheet-$)
  • Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed Inspections (Gray Sheet-$)
  • FDA approves Boston Scientific's Precision Montage MRI-safe spinal cord stimulator (MassDevice)
  • Still Some Gaps In FDA 3-D Printed Medical Device Guidance (Law360-$)
  • Should We Worry about TAVR Durability? (MDDI)
  • FDA approves first standalone 3-D mammography system for Siemens (Fierce)

US: Assorted & Government

  • U.S. bill proposed to reform Native American health agency (Reuters             )
  • Oklahoma lawmakers OK bill criminalizing performing abortion (AP)
  • Hillary Clinton's Medicare 'Buy-In' Could Cover 7M Uninsured (Forbes)
  • Healthcare complaints matter: the need to improve the system (Harvard Bill of Health)
  • Food Safety: FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed (GAO)
  • Guest Post - The Connecticut Supreme Court Modifies The State's Consumer Expectation Test By Adopting The Modified Test (Drug and Device Law)
  • Trimming Some Fat From Statin Litigation With Daubert and Preemption (Drug and Device Law)

Upcoming Meetings & Events


  • NHS overspend in England hit £2.45bn last year (OnMedica)
  • Foreign investment and increased imports to dominate Russian and ASEAN markets (BioSpectrum)
  • 22% Leap In Certificates Withdrawn By Notified Bodies As Oversight Gets Even Tougher (Clinica-$)
  • Why Drug Developers Need To Seek Scientific Advice From The EMA (SCRIP-$)
  • Nice backs Novartis' lung cancer drug (Pharmafile)
  • A Busy Week for the EU Inspectorate Publishing Reports of GMP Non-Compliance (Unger)
  • Pfizer Announces European Medicines Agency Acceptance for Review of Marketing Authorization Application for TRUMENBA® (Meningococcal Group B Vaccine) (Press)


  • 22 Japanese organizations to be part of San Francisco's Biotech Convention: JETRO (BioSpectrum)
  • Tackling Indonesia's diabetes challenge: Eight approaches from around the world (McKinsey)


  • Does USITC Report On TPP Tip The Scale For India To JOIN? (24 Insight)
  • India to get detailed U.S. FDA data on rejected food, drug imports (Fierce)
  • Indian generic drug companies require innovative packaging to tap global markets: Essentra Asia chief (PharmaBiz)
  • AIOCD delegation soon to meet CDSCO officials seeking rollback of hike in licence fees (PharmaBiz)
  • Quality Concerns Continue To Haunt Indian Generic Pharma (24 Insight)


  • Medicine shortages: Clomifene / clomiphene (TGA)
  • TRUEresult blood glucose test strips (TGA)


  • Stealing From Ebola to Fight Zika (NYTimes)

Other International

  • WHO Calls Yellow Fever in Africa 'Serious Concern' (NYTimes) (WHO)

General Health & Other Interesting Articles

  • Visual impairment, blindness cases in U.S. expected to double by 2050 (NIH)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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