Regulatory Recon: FDA Panel Votes Against Testosterone Therapies Endo Subpoenaed for Opioid Information (11 January 2018)

Posted 11 January 2018 | By Michael Mezher 

Regulatory Recon: FDA Panel Votes Against Testosterone Therapies Endo Subpoenaed for Opioid Information (11 January 2018)

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

In Focus: US

  • The FDA still hates low T drugs — experts bat back a pair of contenders (Endpoints) (Medpage) (Fierce) (Lipocine)
  • Endo subpoenaed for information on opioid painkillers (Reuters) (WSJ)
  • An 'unsustainable' model: Drug makers signal interest in exiting vaccine development during crises (STAT)
  • JPM18 Day 3: Valeant and Acorda make plans, promises of M&A (BioPharmaDive) (Pink Sheet-$) (Xconomy)
  • JP Morgan Health Conference All About The Deals Amid Uncertainty For Millions (KHN)
  • How can we reduce drug prices while preserving robust research and development? (Hopkins Bloomberg)
  • Adapsyn signs $162M microbe-mining deal with Pfizer (Fierce)
  • Investigation Raises Concerns About Animal Study Misreporting (Medpage)
  • Overhaul of 340B program could happen this spring, key Republican says (STAT) (BIO)
  • Pfizer, Boehringer sign JLABS resident Distributed Bio's antibody discovery platform (Fierce)
  • Pfizer oncology head Liz Barrett jumps ship to Novartis as Bruno Strigini steps aside (Endpoints) (Pharmafile)

In Focus: International

  • Philippines exhumes bodies of two children in dengue vaccine probe (Reuters)
  • Teva's board slashes its own compensation following massive restructuring (Endpoints)
  • AZ gets EMA green light for severe asthma drug Fasenra (PMLive) (Pharmafile) (PharmaTimes)
  • Nestle Takes Lead in Bids for Merck's Consumer Unit (Bloomberg)
  • JPM18: Biotech CEOs unfazed by Brexit (BioPharmaDive)
  • Valeant CEO Is in the Midst of the 'Turnaround Opportunity of a Lifetime' (Bloomberg)
  • Pfizer and Roche among sponsors of HTA data-sharing initiative (PharmaLetter-$) (PMLive) (BioCentury)
  • Indian pharma majors weigh bids for Sanofi's $2 billion European generics business (Economic Times)
  • CDSCO teaming up to re-inspect manufacturing plants of pharma cos in next three weeks (Economic Times)
  • CFDA Planning To Double Reviewers (BioCentury)
  • Eisai ups capacity for Alzheimer's disease pills and PPIs in China (InPharmaTechnologist)
  • UK Takes Stricter Stance on Human Factors Engineering for Medical Devices (Emergo)
  • MHRA streamlines services for devices customers (MHRA)
  • Ferring Forges Fertility Pact With Chinese Academy of Sciences (SCRIP-$)

Pharmaceuticals & Biotechnology

  • 'I recognize the responsibility I have': At #JPM18, a Big Pharma female CEO weighs in on diversity (STAT)
  • JP Morgan day two roundup – quiet, but no bad news (EP Vantage) (National Law Review)
  • Kite Earns Patent for Method to Increase Efficacy of CAR-T (GEN)
  • After 5 years, Eliquis' growth ceiling is nowhere in sight: Bristol-Myers CEO (Fierce)
  • AIDS charity lambasts "ethically challenged" Gilead over price hikes (Pharmafile)
  • Shire CEO Flemming Ornskov is hatching a few new stretch goals for R&D in 2018 — and beyond (Endpoints)
  • Pacira's Exparel For Nerve Block Use Gets Day-Plus US FDA Panel Review (Pink Sheet-$)
  • FDA Wants Risk Assessments To Support Post-Approval Changes For Biologicals (Pink Sheet-$)
  • Who owns your tissue? You'd be surprised (The Globe and Mail)
  • Eye Drug Delivery Firm Eyenovia Sets IPO Range as Plans Come Into Focus (Xconomy)
  • Immune-Related Adverse Events Associated with Immune Checkpoint Blockade (NEJM)
  • Alexion aims for best-ever Soliris launch with new myasthenia gravis indication (Fierce)
  • BioLegend licenses transcriptome tech from NY Genome Center (Fierce)
  • Where To Gamble On Genomics? In Atlantic City, Where They Know The Odds (Forbes)
  • 2026 Pharmacist Job Outlook Looks Good, Especially for Hospital Pharmacists (Drug Channels)
  • Boehringer taps Adimab for antibody discovery project (Fierce)
  • Charles River buys KWS BioTest for $20M, gaining immunology discovery capacity and a UK footprint (Endpoints) (GEN)
  • Dr Aidan Murphy becomes Ipsen's new Executive VP, Technical Operations (Pharmafile)
  • In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word? (Pink Sheet-$)
  • ANDAs By The Numbers: Metrics Look Good – But Review Processes Need Attention Too (Pink Sheet-$)
  • 2017 – Recap of Warning Letters, Import Alerts and Non-Compliances (Pharmacompass)
  • Venture Funding Deals: Orchard Therapeutics Spreads Its Roots (SCRIP-$)
  • The effect of a potentially tamper-resistant oxycodone formulation on opioid use and harm: main findings of the National Opioid Medications Abuse Deterrence (NOMAD) study (The Lancet)
  • International Laboratories, LLC Issues Voluntary Nationwide Recall of (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in bottles of 30 tablets (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • German Biotech Gets FDA Backing for Ulcerative Colitis Phase II Study (Labiotech)
  • Astellas files sNDA for diabetes drug (PharmaLetter-$) (Press)
  • Helsinn Group and MEI Pharma Announce that Pracinostat has Received Orphan Drug Designation from the European Medicines Agency for the Treatment of Acute Myeloid Leukemia (AML) (Press)
  • First Treatment for MERS Appears Safe in NIH Phase I Clinical Trial (Press)

Medical Devices

  • Class 1 Device Recall Certitude Delivery System (FDA)
  • FDA approves Boston Scientific's Spectra WaveWriter chronic pain device (MassDevice)
  • 3-D Printed Implants Pose Challenge For Product Regulators (Law360-$)
  • 2017 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel (FDA)
  • Glaukos touts Ph2 glaucoma trial for drug-eluting intraocular implant (Drug Delivery)

US: Assorted & Government

  • Trump administration will allow states to test Medicaid work requirements (Reuters) (Forbes) (CMS) (Public Citizen)
  • Guest Post – Putting the "Specific" Back in Specific Jurisdiction: The Importance of Claim-By-Claim Jurisdictional Analysis in a Post-BMS Landscape (Drug & Device Law)
  • Arbitrating Pharma Disputes On The Rise – Planning Ahead Makes Sense (SCRIP-$)
  • Judge deals setback to Cherokee Nation lawsuit over opioids (Reuters)
  • Law360's Pay-For-Delay Case Cheat Sheet For 2018 (Law360-$)
  • Allergan's Restasis Patents Are Valid, Fed. Circ. Told (Law360-$)
  • What if CHIP Funds Run Out? Here's What 6 Families Would Do (NYTimes)
  • Extending Funding for the Children's Health Insurance Program for 10 Years (CBO)

Upcoming Meetings & Events


  • EU Issues GMP Guide For Investigational Drugs Under Clinical Trials Regulation (Pink Sheet-$)
  • EMA Extends Benefits Of Reduced Parallel Distribution Fee To Estonia, Slovenia (Pink Sheet-$)
  • NHS no longer able to deliver on standards, warn bosses (Pharmafile)
  • A cluster of multidrug-resistant Mycobacterium tuberculosis among patients arriving in Europe from the Horn of Africa: a molecular epidemiological study (The Lancet)
  • Siemens Healthineers closes Fast Track Diagnostics buy (MassDevice)
  • Ventripoint Diagnostics wins CE Mark for VMS+ heart analysis system (MassDevice)
  • Hologic wins CE Mark for Brevera breast biopsy system (MassDevice)
  • Check-Cap wins CE Mark for C-Scan diagnostic capsule (MassDevice)


  • Made in China: Boehringer-Ingelheim to make first mAb from new Shanghai plant (BioPharmaReporter)
  • China: Foreign CMOs to take advantage of changing policies, says Wuxi Griffin (InPharmaTechnologist)


  • Domestic medical device makers seek hike in basic custom duty (Economic Times)


  • Black Triangle Scheme - Information for Sponsors (TGA)

Other International

  • UN Environment and WHO agree to major collaboration on environmental health risks (WHO)

General Health

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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