Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Intrarosa for Pain During Sex for Postmenopausal Women (17 November 2

Regulatory Recon: FDA Approves Intrarosa for Pain During Sex for Postmenopausal Women (17 November 2016)

Posted 17 November 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Intrarosa for Pain During Sex for Postmenopausal Women (17 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • FDA approves Intrarosa for postmenopausal women experiencing pain during sex (FDA)
  • Trump's Biotech Rally Based on False Hopes (WSJ)
  • Here's Why a Trump Administration Should Boost the Biotech Sector (The Street)
  • Medical Research Group Optimistic Trump Will Boost NIH Funding (Bloomberg)
  • What's Trump's Plan for U.S. Biomedical Research? (MIT Technology Review) (S&P)
  • Drug prices don't budge even after pressure from Congress (AP)
  • Which way for Trump and progressives on pharmaceutical reform? (The Hill)
  • High-dollar Prescribers Proliferate in Medicare's Drug Program (ProPublica)
  • High stakes: Eli Lilly's hunt for an Alzheimer's drug (Financial Times)
  • Variability in Retail Pricing of Generic Drugs for Heart Failure (JAMA)
  • Janssen seeks FDA approval for IL-23 blockbuster hopeful guselkumab (Fierce) (Press)
  • FDA, Industry Members Propose Models for Real-World Clinical Trials (FDANews-$)
  • The CEO of Valeant's secret pharmacy has been charged with 'engaging in a multimillion-dollar fraud and kickback scheme' (Business Insider) (DoJ)
  • Two Big Moves at FDA: Cybersecurity and Real World Evidence (MDDI)
  • GlaxoSmithKline Must Face Insurers' Drug Fraud Claims (Bloomberg)
  • FDA and Industry: How Dangerous is the Revolving Door? (Focus)
  • Using Twitter as an Intelligence Tool: 85 Accounts Worth Following (Focus)
  • CDK4 and CDK6 Inhibition in Breast Cancer — A New Standard (NEJM)
  • How drug price pressure helped sink Novo's insulin pill (Reuters)
  • Theranos Whistleblower Shook the Company—And His Family (WSJ)
  • FDA Appeals PREPOPIK NCE Exclusivity Decision to the D.C. Circuit; Similarly Situated Parties Petition FDA (FDA Law Blog)
  • No early win for Sanofi, Regeneron cholesterol drug in study (Reuters) (Xconomy) (Press)
  • Amgen, Novartis aim for big, crowded migraine market after new drug data (Reuters) (Xconomy)
  • Antibiotic Development: 'Wildcard Exclusivity' Proposal Returns (Pink Sheet-$)
  • Value-Based Reimbursement For Antibiotics Gets Skeptical Reception (Pink Sheet-$)

In Focus: International

  • Amgen Exec Backs WHO's 'Biological Qualifier', Says First Ones Could Be Issued By End Of 2017 (Pink Sheet-$)
  • Celltrion's Rituxan biosimilar receives sales approval in Korea (Korea Herald)
  • CDSCO: 76 Sites Inspected Under Risk-Based Inspection Scheme (CDSCO)
  • SAGE-547 granted PRIME designation by EMA for postpartum depression (PharmaLetter-$)
  • Roche drops price of breast cancer drug for NICE approval (PharmaTimes) (The Guardian) (Reuters) (NICE)
  • India: Pharma research approval system to be put on fast track (Economic Times)
  • Over 75% of CDF drugs reappraised by NICE now approved for routine use (PharmaLetter-$) (EPR)
  • UK on track to cut antibiotic use in animals as total sales drop 9% (GOV.UK)
  • uniQure to axe jobs and consolidate operations in cost-saving measures (BioPharmaReporter)

US: Pharmaceuticals & Biotechnology

  • Mixed Results For ApoA-1 Therapies (CardioBrief) (EPVantage)
  • Bevacizumab Biosimilar Nears Market As Amgen Files First At FDA (SCRIP-$) (EPVantage)
  • Boehringer says Avastin biosimilar on track as Phase III gets underway (PMLive)
  • A fungus among us: FDA adcom tempers Cempra, lefamulin affair starting? (BioWorld)
  • A Post-Election Projection: The 2025 Payer Market for Prescription Drugs (Drug Channels)
  • OGD Releases October 2016 Statistics (Lachman Consultants) (Pharmaceutical Manufacturing)
  • Building on the promise of personalized medicine (PhRMA)
  • Allocation concealment in randomised controlled trials: are we getting better? (The BMJ)
  • Rebooting The Conversation (LifeSciVC)
  • Some respiratory infections may not need antibiotics (Reuters)
  • Rethinking the Ban — The U.S. Blood Supply and Men Who Have Sex with Men (NEJM)
  • New drug capsule delivers medicine for weeks after swallowing (Reuters) (STAT)
  • Another company moves HQ out of Illinois (Chicago Business)
  • Drugs Are Killing More Americans Than Road Crashes [Infographic] (Forbes)
  • How to Lower Drug Prices, Improve Care, and Save Pharma (Xconomy)
  • Hey Gilead, Stop Developing Drugs and Start Buying Biotech Companies -- Now! (The Street)
  • Two Former FDA Senior Officials Join Greenleaf Health (Press)

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

  • Mixed Phase III results for Gilead's momelotinib in myelofibrosis (BioCentury) (Press)
  • Sanofi And Regeneron Present Results From Phase 3 Monarch Study Of Investigational Sarilumab At American College Of Rheumatology Annual Meeting (Press)
  • Bristol-Myers Squibb Presents New Data at IASLC 17th World Conference on Lung Cancer Underscoring Progress and Leadership in Broad Lung Development Program (Press)
  • Agilis Biotherapeutics Achieves FDA "Rare Pediatric Disease" Designation for AADC Gene Therapy Candidate (Press)
  • Reviva Pharmaceuticals Receives FDA Orphan Designation for Pulmonary Arterial Hypertension (PAH) (Press)
  • Janssen Submits Application To FDA Seeking Approval Of Anti-Interleukin-23 Monoclonal Antibody Guselkumab For The Treatment Of Moderate To Severe Plaque Psoriasis (Press)
  • Ra Pharmaceuticals Receives Orphan Drug Designation in the European Union for RA101495 for Treatment of Paroxysmal Nocturnal Hemoglobinuria (Press)
  • PALOMA-2 Phase 3 Study Published In The New England Journal Of Medicine Demonstrates Clinical Benefit Of Pfizer's IBRANCE® (palbociclib) In First-Line ER+, HER2- Metastatic Breast Cancer (Press)
  • FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Multiple Invasive Fungal and Mold Infections (Press)
  • Pharnext Announces that the Data Safety Monitoring Board Recommends Continuing the Ongoing Phase 3 Trial of PXT3003 for Charcot-Marie-Tooth Disease Type 1A (Press)
  • Spectrum Pharmaceuticals Announces Poziotinib Data Presentation at the 17th IASLC World Conference on Lung Cancer in Vienna, Austria, December 4-7, 2016 (Press)
  • Novocure Presents Interim STELLAR Results at IASLC Suggesting Treatment with Tumor Treating Fields Plus Chemotherapy may Extend Survival of Patients with Mesothelioma (Press)

US: Medical Devices

  • Post-Election Commentary from Medtech Executives (MDDI)
  • Duke-Margolis: User Fees A Start For NEST, But Approps, Private Funds Key (IHP-$)
  • FDA posts 2 new Class I HeartWare HVAD recalls (MassDevice) (FDA 1, 2)
  • Olympus wins FDA nod & launches new power morcellator with tissue capture (MassDevice)
  • New St. Jude heart pumping device proves superior to older model: study (Reuters) (MassDevice)
  • FDA expands indication for Medtronic's Solitaire stent retriever (MassDevice)
  • Actamax touts clinical data for sprayable adhesion barrier device (MassDevice)
  • Cellnovo files 510(k) for connected diabetes management system (Drug Delivery)
  • Endologix shares dive on FDA request for more Nellix data (MassDevice)
  • Baxter to Present 24 Abstracts at ASN Kidney Week 2016 Focused on Elevating the Standard of Care For Dialysis Patients Globally (Press)

US: Assorted & Government

  • Murray Remains Ranking Democrat On Health Committee; Leahy Becomes Ranking On Approps, Cites Opioids, Infectious Disease, Cancer Research As Priorities (IHP-$)
  • Surgeon General's Report on Alcohol, Drugs, and Health (JAMA)
  • Missouri appeals court: Frozen embryos are property, not people (CBS)
  • Fetal Tissue Panel Lawmaker to Be Part of Trump's Transition (Bloomberg)
  • Total abortion ban proposed in Indiana (IndyStar)
  • Associations Representing Over 200 Research Universities Call for #CuresNow (E&C)
  • A Day Shopping At Walmart and Mensing Preemption (Drug and Device Law)
  • Sign-Ups Under Affordable Care Act So Far Seem Not Hurt by Donald Trump's Win (WSJ)

Upcoming Meetings & Events


  • Minutes of the 93rd meeting of the Management Board (EMA)
  • Prytime's ER-REBOA Emergency Aorta Occluder Cleared in Europe (MedGadget)
  • Grünenthal buys Thar to expand late-phase pain pipeline (Fierce)
  • Outcome of the Process - Public Consultation on Proposed Fees for 2017 (HPRA)


  • CEOs of pharma companies to discuss key challenges within industry (Economic Times)
  • Lupin gets USFDA nod for generic pain relieving drug (Economic Times)
  • Sun Pharma's Taro recalls 17,100 dandruff care kits in US (Economic Times)


  • HeartFlow FFRct Analysis Receives Regulatory Approval in Japan (Press)


  • Prescription medicines: registration of new chemical entities in Australia (TGA)
  • Hazard Alert: Nellix EndoVascular Aneurysm Sealing System (TGA)
  • Section 23 instruments (TGA)

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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