Regulatory Focus™ > News Articles > Regulatory Recon: Lawmakers Call on NIH to March In on Xtandi, FDA Denies Expanded Label for Brinte

Regulatory Recon: Lawmakers Call on NIH to March In on Xtandi, FDA Denies Expanded Label for Brintellix (29 March 2016)

Posted 29 March 2016 | By Michael Mezher 

Regulatory Recon: Lawmakers  Call on NIH to March In on Xtandi, FDA Denies Expanded Label for Brintellix (29  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

  • Value Pricing For Drugs: Whose Value, What Price? (Health Affairs Blog)
  • How To Help Rare Disease Patients: Stop Spending So Much On "Bridges To Nowhere" (Forbes)
  • Valeant Chief to Testify Before Senate in April (AP) (WSJ-$)
  • Inside the Valeant Scandall (The New Yorker) (STAT)
  • Biosimilar drugs could save up to $110 billion by 2020: IMS (Reuters)
  • Theranos Results Could Throw Off Medical Decisions, Study Finds (WSJ-$) (Forbes) (The Verge)
  • Want Into A Clinical Trial? Read This First (KHN)
  • Buying Costly Drugs On The Installment Plan: Could It Work? (NPR)
  • Arthur Caplan and Alison Bateman-House: Seven good reasons to not support right to try experimental drug legislation in Connecticut (CT Post)
  • FDA Rejects Takeda, Lundbeck's Label Expansion for Brintellix (STAT) (Bloomberg) (Press)
  • True or False: Only Two Out of Ten Drugs Earns Back Its Development Costs? (LymanBiopharma)
  • Sanders, other lawmakers seek NIH hearing to override drug patent(STAT) (Reuters) (Letter)
  • Cancer Treatment's New Direction (WSJ-$)
  • Pharma companies are sharing their data — but few are looking (Washington Post)
  • Key meeting next week offers federal experts new chance to curb antibiotics in livestock (Medium)

In Focus: International

  • A Dose of the TPP's Medicine: Why U.S. Trade Deals Haven't Exported U.S. Drug Prices (Foreign Affairs)
  • CF drug Kalydeco took up 86% of Scotland's rare disease fund (PharmaPhorum)
  • Vietnam's Battle With Tuberculosis (NYTimes)
  • India Releases New Biosimilars Guidance (Focus)

US: Pharmaceuticals & Biotechnology

  • Molecular Answers Found for a Mysterious Rare Immune Disorder (NIH)
  • How Should SPRINT Influence High Blood Pressure In Children And Adolescents? (CardioBrief)
  • FDA's Next Step to Real-World Evidence: Prove That Real-World Studies Can Match Known RCT Results (Pink Sheet-$) (Focus)
  • Transparency: What FDA Drug, Device Regulations are Coming Later in 2016 (Focus)
  • America's biopharmaceutical industry is central to diverse R&D ecosystem (PhRMA)
  • Amarin and Off-Label Promotion: What's Next? (MedpageToday)
  • You survived cancer. Now what? (Washington Post)
  • FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge (Pink Sheet-$)
  • Bloomberg, others give Hopkins $125 million for cancer research that helped Jimmy Carter (Washington Post)
  • How US Can Learn From Biosimilar Implementation In EU (Pink Sheet-$)
  • Pediatric Studies of Lorazepam; Establishment of Public Docket (FDA)
  • Committee Will Sift Through 'Noise' Associated With Nuplazid Efficacy (Pink Sheet-$)
  • The Xconversation: Vaccine Developer Meets Energy Innovator, Part I (Xconomy)
  • The FDA's Support For Abuse-Deterrent Opioids May Not Be Enough (Forbes) (Focus)
  • Skin Infection Patients Adhere to Just Over Half of Their Antibiotic Regimen, Study Finds (MPR)
  • Keeping Up With The CGRPs: Alder Gains Momentum In A Tight Race (Pink Sheet-$)

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

  • Keryx Biopharmaceuticals Announces Positive Top-Line Results From Pivotal  Phase 3 Study Of Ferric Citrate For The Treatment Of Iron Deficiency Anemia  In Adults With Non-Dialysis Dependent Chronic Kidney Disease (Press)
  • (FDA Approves BioCSL Afluria Flu Vaccine (FDA)
  • FDA accepts NDA for Aralez's Yosprala (BioCentury)
  • FDA Approves Supplemental New Drug Application (sNDA) for Boehringer Ingelheim's STIOLTO RESPIMAT for COPD Health-Related Quality of Life (Press)
  • Kolltan Pharmaceuticals to Present Preclinical Data at the 2016 American Association for Cancer Research (AACR) Annual Meeting (Press)
  • Kedrion Biopharma Receives FDA Approval to Package Koāte Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2VialTM Needle-Free Transfer Device (Press)
  • Cairn Diagnostics Launches FDA-Approved Spirulina Gastric Emptying Breath Test for Gastroparesis (Press)
  • Lannett Receives FDA Approvals For Two Products (Press)

US: Medical Devices

  • New CDRH Learn Modules for UDI (FDA)
  • Domestic, Foreign Manufacturers Achieve Virtual Quality-Related FDA Warning Letter Parity; Missive-Counting Methodologies Explained (Gray Sheet-$) (Focus)
  • Blood test that can find evidence of a concussion days later is closer to becoming a reality (Washington Post)
  • Quanterix's Magnetic Tech for Fighting Football Concussions (IEEE Spectrum)
  • Sharper Reading Vision—in One Eye (WSJ-$)
  • Harvard launches ResearchKit study to track and compare health of former NFL players, general public (mobihealthnews)
  • How Do Phyisicians View Boston Scientific's Watchman Device? (MDDI)
  • Fed judge rules case against Bayer's Essure birth control device to move forward (Fierce)
  • An Innovative Patient-Centered Total Joint Replacement Program (Health Affairs Blog)
  • FDA Clears CorPath Robotic System for Use in Peripheral Vascular Intervention (Press)
  • V-Wave touts 1st-in-human for interatrial shunt (MassDevice)
  • Tenex Health Secures FDA Clearance for the TX2 MicroTip, Providing a Minimally Invasive Solution for Chronic Tendinosis (Press)

US: Assorted & Government

  • All Was Not Lost: Fifth Circuit Issues En Banc Decision Reversing Panel's Earlier Remand Ruling in Flagg v. Stryker Corp. (Drug and Device Law)
  • Amgen Asks the Supreme Court to Reject Challenge to Ruling that Notice of Commercial Marketing is Mandatory, But Asks for Review of Patent Dance Ruling Just in Case (FDA Law Blog)
  • Shire gets favorable ruling against Allergan in Lialda patent case (Reuters)
  • FDA Looking for Two New Cellular and Gene Therapy Fellows (Focus)

Upcoming Meetings & Events


  • Meeting With EU Regulatory Agencies: Part I (Focus-$)
  • CHMP Draft Agenda for 29 March Meeting (EMA)
  • Anika Therapeutics wins CE Mark for Cingal knee treatment (MassDevice) (Press)
  • Stentys wins CE Mark for Xposition S self-apposing coronary stent (MassDevice)
  • NICE drops acupuncture from back pain guidelines (PharmaTimes)


  • Japan clears Zoll's Thermogard XP for sudden cardiac arrest (MassDevice)
  • Bayer receives approval for Xofigo, Kovaltry in Japan (Reuters)
  • Glaukos gets the OK from Japan for its iStent device designed to treat glaucoma (MedCityNews)
  • Eximbank, Innovation Center to support start-ups (Korea Herald)
  • Japanese approvals for Alexion, Eisai, Biocon (BioCentury)
  • China's new 'new' (BioCentury)


  • CDSCO plans to increase audits of mfg units to ensure quality of drugs in global markets (PharmaBiz)
  • Drug ban row continues as Delhi High Court extends stay (Economic Times)
  • India's Lupin says it sees no supply disruption at plant despite FDA observations (Reuters) (Economic Times)
  • How US Foreign Assistance To India Hinges On Pseudoephedrine (24 Insight)
  • Natco takes a beating on FDA observation (Economic Times)
  • Aurobindo Pharma gets final USFDA nod for dementia drug (Economic Times)
  • Government banned fixed drug combinations without considering clinical data: Pharma companies (Economic Times)
  • Cadila gets USFDA nod to sell generic anti-viral drug  (Economic Times)


  • MRA GMP clearance application processing timelines (TGA)


  • The race is on to develop Zika vaccine (Nature)
  • Zika Study Could Help Overcome an Obstacle to Vaccine Research (NYTimes)
  • U.S. scientists develop mouse model to test Zika vaccines, drugs (Reuters)
  • HHS ships blood products to Puerto Rico in response to Zika outbreak (HHS)
  • Health officials confirm first case of Zika virus in Arizona (CBS)

General Health & Other Interesting Articles

  • Testing to Start for Computer With Chips Inspired by the Human Brain (WSJ-$)
  • I thought I was too young for arthritis. I was wrong. (Washington Post)
  • New Model for Meeting the Needs of the Most Fragile Children (WSJ-$)
  • Vaccines, breastfeeding tied to decline in ear infections (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

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

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