Regulatory Focus™ > News Articles > Regulatory Recon: Lilly Sarcoma Drug Wins Accelerated Approval; FDA Panel Backs Allergan Nocturia Na

Regulatory Recon: Lilly Sarcoma Drug Wins Accelerated Approval FDA Panel Backs Allergan Nocturia Nasal Spray (20 October 2016)

Posted 20 October 2016 | By Michael Mezher 

Regulatory Recon: Lilly Sarcoma Drug Wins Accelerated Approval FDA Panel Backs Allergan Nocturia Nasal Spray (20 October 2016)

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

In Focus: US

  • FDA's CBER Restructures And Creates New Office Of Tissues And Advanced Therapies (Focus)
  • FDA Leader Defends Agency's Drug Approval Process (Bloomberg)
  • FDA grants accelerated approval to Lilly's soft tissue sarcoma drug (Reuters) (FDA) (Press)
  • FDA's Jenkins says Sarepta's path is not a model (BioCentury) (Fierce) (FDA)
  • GPhA Report Details Generic Drug Savings (GPhA) (Report)
  • Who Needs A Control Arm? (In The Pipeline)
  • Introducing FDA's Emerging Sciences Idea Portal: Please Help Us Predict the Future (FDAVoice)
  • Kite Pharma's CEO On Bringing Cancer-Killing T-cells To The FDA (Forbes) (EPVantage)
  • Collaborative leukaemia trial orbits moonshot initiative (EP Vantage)
  • Califf, Biden Task Force Tout NIH Rule Requiring Failed Trial Data Be Posted (Inside Health Policy)
  • FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling (Focus)
  • Q&A: Janssen on where it is heading with real world evidence (Pink Sheet-$)
  • All In One Place: A New Immuno-Oncology Trial Resource (Xconomy)
  • Small Savings For Drugs Made To Mimic Biotech Blockbusters (NPR)
  • Cancer Immunotherapies Have FDA, Industry Looking For New Endpoints (Pink Sheet-$)
  • Vermont Governor Proposes Limits on Painkiller Prescriptions (NYTimes)
  • FDA panel backs Allergan's drug for frequent nightly urination (Reuters) (Medpage)
  • Abbott Labs Swings to Loss After Booking Charge on Mylan Stake (WSJ)
  • Abbott moves ahead on St. Jude, Alere deals, but investors fret (Reuters)

In Focus: International

  • FDA Warns Teva's Banned Hungary Manufacturing Facility (Focus)
  • Roche third-quarter sales rise 3 percent, confirms outlook (Reuters) (Press)
  • Fujifilm/Kyowa biosimilar shows equivalence to Humira (BioCentury)
  • Aspen to appeal Italian Competition Authority fine for alleged excessive price hikes (PharmaLetter-$)
  • EMA Prioritizes Three New Treatments As Part Of Its PRIME Scheme (Focus)
  • New ICH Guideline Marks Turning Point In Supporting Multi-Regional Pediatric Development (Pink Sheet-$)
  • WHO seeks new mechanism for crisis vaccine supplies at low cost (Reuters)
  • EFPIA Urges Japan To Consider New Funding Models (Pink Sheet-$)
  • New ISO Standard Seeks to Reduce Risk in Intravenous Drug Deliver (ISO)
  • Psoriasis patients to get NHS access to Otezla (PharmaTimes)
  • NICE backs new therapy for Fabry disease (PharmaTimes)
  • Lobby group links antibiotic resistance to 'dirty' drug factories, and Aurobindo is a culprit (Fierce) (Report)

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US: Pharmaceuticals & Biotechnology

  • Results Wire: US FDA Advisory Committee Majority Vote Supports Desmopressin Nasal Spray by Serenity Pharmaceuticals - OCT 19, 2016 (BRUDAC) (Tarius)
  • Biotech IPO market remains open but investors prove picky eaters (EP Vantage)
  • What is Driving Industry Crazy Lately? (Lachman Consulting)
  • Medicare subsidies may help more women stick with breast cancer drugs (Reuters)
  • The case for healthcare cooperation with Cuba (Health Business Blog)
  • An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar (Patent Docs)
  • Cerulean, Novartis to develop drug conjugates (BioCentury)
  • Pricing Transparency Policies Not Suited To Generics, GPhA Argues (Pink Sheet-$)
  • Samsung Bioepis contracts Catalent to help commercialize Benepali (BioPharmaReporter)
  • Scientists think the common cold may at last be beatable (STAT)
  • Pre-teens need only two HPV shots, not three, CDC recommends (Reuters) (Press)
  • The Pharmafocus guide to the US presidential election 2016 (Pharmafile)
  • AbbVie rejects Ablynx RA drug on cusp of PhIII (Fierce)
  • FDA Modifies Tarceva Indication for Lung Cancer (MPR)
  • Q&A With FDA's Pediatric Drugs Director Dianne Murphy (FDA)
  • Sandoz Wants FDA to Raise Approval Requirements for Generics of GSK's Advair Diskus (FDANews-$)
  • Card-carrying pharma reps? Chicago eyes licensing for painkiller promoters (Fierce)
  • Benefiting from Innovative Clinical Trial Designs (BIO)
  • Philly-based gene therapy firm teams up with UMass Medical researcher (Boston Business Journal)
  • The Power of the Cloud for Life Science R&D (Xconomy)

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

  • First Patient Cohort Data From BioTime's OpRegen® Clinical Trial in Dry-AMD to Be Presented at ISOPT Clinical Symposium on December 2, 2016 (Press)
  • FDA Grants Orphan Drug Designation to ALXN1007 for the Treatment of Patients with Graft-Versus-Host Disease (GVHD) (Press)
  • Those risk disclosures on drug websites? People don't read them, study says (Fierce)
  • Rigel Pharma Announces Results From Second FIT Phase 3 Study - Quick Facts (RTTNews)

US: Medical Devices

  • Medtronic warns on deep brain stimulation charger issue (MassDevice)
  • Medical Devices Must Show Value Other Than Price (Bloomberg)
  • Short-seller Muddy Waters floats more videos claiming cybersecurity risks with St. Jude Medical's cardiac devices (MassDevice)
  • Water-based implant new option for Americans with big toe damage (Reuters)
  • Fujitsu Is The Latest To Use AI In Healthcare With New DNA-Analyzing Computer (Forbes)
  • CareFusion lays off 128 in California (MassDevice)
  • Abbott's Q3 results beat The Street despite surprise swing to red ink on Mylan stake (MassDevice)
  • St. Jude Medical misses with Q3 results (MassDevice)

US: Assorted & Government

  • Obama to give his diagnosis for what ails Obamacare (Reuters)
  • U.S. government sees 1 million more people on Obamacare exchanges in 2017 (Reuters) (Health Affairs Blog)
  • Trouble on the Exchanges — Does the United States Owe Billions to Health Insurers? (NEJM)
  • A Recently Discovered Gem (Drug and Device Law)
  • USPTO Wins Dispute Over Extension For Drug Patent (Law360-$)
  • Alexander: 2,366 Hamblen Countians on Obamacare Lose Blue Cross Blue Shield as an Option Next Year, Will Have Only 1 Insurer to Choose From (HELP)
  • Gilead Says Ferring Win Should Extend HIV Drug Exclusivity (Law360-$)
  • Drug Prices: Can Medicare Get a Better Deal? (Medpage)
  • Theranos' Woes May Reshape Private D&O Coverage (Law360-$)
  • Merck Cleared in Whistleblower Protection Suit (Pharmaceutical Manufacturing)

Upcoming Meetings & Events


  • 'Standardized' comment from Brexit minister raises hopes for parallel EU/UK drug approval system (Pink Sheet-$)
  • EU Commission sketches possible directions for FP9 (Science Business)
  • Boehringer Offers EU Concessions For Sanofi Swap Deal (Law360-$)
  • Oxford Genetics boosts cell/gene therapy R&D with new facility (Pharmafile)
  • CVMP strategy on antimicrobials 2016-2020 (EMA)
  • AXON expands with new Switzerland branch (PM Live)
  • NICE to tackle 'underdiagnosed' coeliac disease sufferers with new quality standards of treatment (EPR)
  • Wales has UK's lowest five-year survival rate for lung cancer (On Medica)


  • Will Japan Pharma Fall In Line With R&D Externalization Trends? (SCRIP-$)
  • CFDA Vice Minister Teng Jiacai meets Chief Agriculture Negotiator of the Office of the U.S. Trade Representative (CFDA)
  • China Precision Medicine Push Boosting Genomic Business Forays (SCRIP-$)
  • China's Tot Biopharm starts work on second plant with eye on ADC market (BioPharmaReporter)


  • Latest draft of medical devices rules disappointing, says industry (Economic Times)
  • Piramal targets Rs 1,000 crore revenue in OTC business on back of buyouts (Economic Times)




  • Online payment of licence application fees by biological manufacturers (TGA)
  • Homeopathic teething products - Safety advisory - potentially harmful for infants and children (TGA)


  • CDC updates guidance related to local Zika transmission in Miami-Dade County, Florida (CDC)

Other International

  • Who Will Be The Next Leader Of WHO? (NPR)
  • GAVI's new half-price vaccines deal will protect more children (PharmaLetter-$)

General Health & Other Interesting Articles

  • On Patrol with America's Top Bioterror Cop (MIT Technology Review)
  • Reports of 'three-parent babies' multiply (Nature)
  • Could we one day use music to diagnose disease? (STAT)
  • STDs Hit Historic High: CDC (Medpage)

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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