Regulatory Recon: FDA Rejects Merck's Bid to Add Heart Data to Januvia Label; Two Gilead HCV Drugs Approved for Pediatric Use (7 April 2017)

Posted 07 April 2017 By Michael Mezher

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

In Focus: US

  • Former FDA chief Margaret Hamburg says Scott Gottlieb will have a 'steep learning curve' (STAT)
  • FDA rejects Merck's application to add heart data on diabetes drug labels (Reuters) (Endpoints) (Press)
  • FDA Approves Sovaldi, Harvoni for Pediatric Patients (FDA)
  • House adjourns with no clear path for repeal (Politico)
  • GOP leader suggests House could be called back from recess to vote on health bill (The Hill)
  • Why So Hard to Kill the Affordable Care Act? (Medpage)
  • Blame Game Over High Drug Prices Escalates With New Ad (Bloomberg)
  • Most drug makers lack evidence their access to medicines program actually work (STAT)
  • Candid Truths From a Biotech IPO (Endpoints)
  • The Cost of Drugs for Rare Diseases Is Threatening the U.S. Health Care System (Harvard Business Review)
  • How Pharma Companies Game the System to Keep Drugs Expensive (Harvard Business Review)
  • FDA Offers its Views on Medical Device Trials (Focus)
  • A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers (Focus)
  • The story behind PhRMA's multimillion-dollar rebranding effort (STAT)
  • While Washington Fiddles, Calif. Leaders Forge Ideas For Universal Health Care (KHN)
  • Can "Digital Therapeutics" Be as Good as Drugs? (MIT Technology Review)
  • Cigna reports 12 percent cut in opioid use among U.S. customers (Reuters)
  • Federal appeals court rules Mylan can proceed with generic Angiomax (Reuters)
  • Is a Challenge to FDA's "Route-of-Abuse" 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon? (FDA Law Blog)

In Focus: International

  • Ailing Novo Seeks Cure With Diabetes Drug Targeting Fat Too (Bloomberg)
  • Novartis takes home rights to Lubris' eye drug (PharmaTimes) (Pharmafile)
  • A Race To Restore Confidence In The World Health Organization (Health Affairs Blog)
  • Europe moves ahead with unified approach to Phase IV monitoring (PharmaLetter-$)
  • Takeda Continues Global R&D Reboot With aNew Joint Venture with PRA (Endpoints)
  • European Parliament Calls for Rapid Relocation of EMA Headquarters (Focus)
  • Politics Could Get In Way Of Quick Decision On New EMA Home (Pink Sheet-$)
  • European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (Focus)
  • China's Fosun big on expanding in pharma (CNBC)
  • Chinese Regulators May be Abolishing Medical Device Testing Fees (Emergo)
  • Changes to submission of ADR reports for unapproved medicines and biologicals (TGA)
  • Gilead discloses China manufacturing plans on a recruitment website (Fierce)
  • EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations? (InsideMedicalDevices)

US: Pharmaceuticals & Biotechnology

  • NHLBI stem cell consortium provides new insights into genetics of heart disease, other conditions (NIH)
  • Trial Of Immune Drug In Breast Cancer Points To Need For Biomarkers (Forbes)
  • Interview – Boehringer plays catch-up in immuno-oncology (EPVantage)
  • The End of the Serotonin Transporter Gene Story? (In The Pipeline)
  • Shire success will support polysialic acid drug delivery platform, says Xenetic (InPharmaTechnologist)
  • Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)
  • Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products (FDA)
  • Fentanyl Adds A New Terror For People Abusing Opioids (NPR)
  • Strike ends at Pfizer plant after firm lets new staff join pension plan (InPharmaTechnologist)

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

  • Spark hemophilia B gene therapy clears another early test (Fierce)
  • U.S. FDA Approves Increased Compassionate Use Patient Cases and Sites for ReCell® in Life-Threatening Injuries (Press)

US: Medical Devices

  • Medtronic recalls devices used to manage fluid build-up in the brain (Reuters) (MassDevice) (Press)
  • Common Medical Device Audit Problems: Difficult Auditees (Emergo)
  • The Technology Redefining Surgery: MR-Guided Focused Ultrasound (MDDI)
  • ISHLT 2017: Less clotting, bleeding events for Abbott's HeartMate 3 (MassDevice)
  • Clinical Trial of Medtronic Heart Pump Delivers Positive Results with Less-Invasive Implant Procedure (Press)
  • Sanofi gets FDA clearance for insulin dose calculator app (MobiHealthNews)
  • A Shocking "Exercize" (FDAVoice)

US: Assorted & Government

  • Advanced Manufacturing: Commerce Could Strengthen Collaboration with Other Agencies on Innovation Institutes (GAO)
  • Gottlieb Should Consider Cannabis As He Makes Opioids His Top Priority (Forbes)
  • PTAB Life Sciences Report -- Part III (Patent Docs)
  • Carl Zeiss claims win over VSY Biotechnology in intraocular lens patent case (MassDevice)
  • After Senate Filibuster's Death, Somber Lawmakers Seek Path Forward (NYTimes)
  • GSK Doc Says FDA Knew All Co. Did About Paxil Suicide Risk (Law360-$)
  • Drugmakers Face Antitrust Class Action Over Diabetes Drug (Law360-$)
  • Celebrex Buyers Seek Class Cert. In Pfizer Antitrust Suit (Law360-$)
  • Mylan, Sandoz, Taro Accused Of Fixing OCD Drug Price (Law360-$)
  • CDC Issues New Warning On Zika Virus Ahead Of Mosquito Season (NPR)
  • West Virginia lawmakers send medical marijuana bill to governor (Reuters)
  • Yum's KFC to curb antibiotic use in the chickens it buys (Reuters)

Upcoming Meetings & Events

Europe

  • Concept paper on a revision of the guideline on the investigation of drug interactions (EMA)
  • Abbott to restrict Absorb bioresorbable stent in Europe (MassDevice)
  • Austria says counterfeit seizures spike in 2016 (Securing  Industry)
  • German billionaire Hopp readies sale of skin patch maker LTS (MassDevice)
  • EMA Guidance Lists Sponsor Requirements for Completing Periodic Safety Reports (FDANews-$)

Asia

  • Zuellig Pharma launches new innovation in center in Singapore (BioSpectrum)
  • Fresenius picks up majority stake in Chinese chronic disease-focused hospital (MassDevice)

India

  • Sun Pharma tanks 3% on surprise USFDA visit to Dadra plant (Economic Times)
  • DoP directs NPPA to revise ceiling prices of 6 formulations of Sun Pharma (PharmaBiz)
  • Indian pharma cos get 55 final ANDA approvals from US FDA in Q1 of 2017 (PharmaBiz)
  • Pharmacovigilance to be part of B Pharm & M Pharm courses by academic year 2018-19 (PharmaBiz)
  • Govt plans to review existing drug price control measures (Economic Times)

Australia

  • Novogen tumbles on termination of oncology candidate (PharmaLetter-$)

Other International

  • Uruguay gives pharmacies green light to start selling marijuana (Reuters)

General Health & Other Interesting Articles

  • Prince's Death: One Year Later, Unsolved Mysteries (NYTimes)
  • Close to Half of American Adults Infected With HPV, Survey Finds (NYTimes)

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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