Regulatory Recon: Biden Hosts Moonshot Summit FDA Rejects Lipocine Testosterone Drug (29 June 2016)

Posted 29 June 2016 | By Michael Mezher 

Regulatory Recon: Biden Hosts Moonshot Summit FDA Rejects Lipocine Testosterone Drug (29 June 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

  • Galena Craters on Breast Cancer Vaccine Study Failure (The Street)
  • Decoding Big Pharma's Secret Drug Pricing Practices (Bloomberg)
  • Drug and Device Makers Find Receptive Audience at For-profit, Southern Hospitals (ProPublica)
  • Shire says ADHD drug meets main goal of study (Reuters)
  • Lipocine says FDA does not approve its testosterone drug (Reuters)
  • Biden Gives a Peek at What's to Come for Cancer Moonshot (Bloomberg) (WSJ)
  • FDA Panel Splits on Expanded Jardiance Indication (Medpage) (Reuters) (Press)
  • Supreme Court spurns abortion restrictions in two more states (Reuters) (Reuters)
  • Pfizer aces another pair of PCSK9 inhibitor trials (Fierce)
  • Gilead Sciences Bucks Tradition, Takes 'Low Road' on New Hepatitis C Drug Price (The Street)
  • Gene-editing: A step closer to homo perfectus (Financial Times)
  • Families see better end-of-life care for cancer than other diseases (Reuters)
  • FDA Issues New Guidance on Conflict of Interest for Advisory Committee Members (Focus)
  • A Proposal To Spur Pharma R&D Investment Into Antibiotics For 'Superbugs' (Forbes)
  • Xarelto Clinical Trial Likened To 'Science Fair Project' By Philly Malpractice Lawyer (Forbes)
  • Congress Should Create Commission to Examine the Protection of Human Participants in Research; Notice of Proposed Rulemaking to Revise Common Rule Should Be Withdrawn (National Academies)

In Focus: International

  • Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators (Focus)
  • FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections (Focus)
  • Zika vaccines prove 100 percent protective in mice; monkey study shows promise (Reuters)
  • Delays As Korea Grapples With Immuno-Oncology Drug Coverage (PharmAsiaNews-$)
  • Medical device regulation in the EU and US needs urgent reform, say experts (MNT)
  • Cuba reports no Zika transmission since March; Dengue all but eliminated (Reuters)

US: Pharmaceuticals & Biotechnology

  • Highly Drug-Resistant Candida Yeast Infection A New Threat To Hospitalized Patients, CDC Warns (Forbes)
  • IBM Donates Use Of Watson To Veterans Health System As Part Of Biden's Cancer Moonshot (Forbes)
  • Esperion says FDA won't commit to surrogate endpoint (BioCentury)
  • AbbVie ends deal for Infinity's duvelisib (BioCentury)
  • FDA Winging It With Brexit: Califf Says Agency Will React To What Happens (Pink Sheet-$)
  • Plan B saves Celyad after heart failure therapy flops (EP Vantage) (PharmaLetter-$)
  • Bad News Bears: After Scary Headlines Some Patients Stopped Taking Statins (CardioBrief)
  • Binge-eating disorder can be treated with talk therapy or drugs (Reuters)
  • Harvard Pilgrim, Lilly partner on Trulicity outcomes (BioCentury)
  • Grit And Giving Up, Experience and Ignorance (In the Pipeline)
  • Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (FDA)
  • Markey Calls for Investigation into Purdue (Policy and Medicine)
  • Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability (FDA)

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

  • AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options (Press)
  • BRIEF-Bayer says regorafenib improves survival in liver cancer patients (Reuters)
  • Merck and Moderna Announce Strategic Collaboration to Advance Novel mRNA-Based Personalized Cancer Vaccines with KEYTRUDA® (pembrolizumab) for the Treatment of Multiple Types of Cancer (Press)
  • Tesaro's ovarian cancer drug shows benefit in late-stage trial (Reuters) (Fierce)
  • Agilis Biotherapeutics Announces FDA Orphan Drug Designation for the Treatment of Aromatic L-amino Acid Decarboxylase Deficiency (Press)
  • Kitov's Lead Drug KIT-302 Achieves Manufacturing Milestone Ahead of Planned NDA Filing with U.S. FDA (Press)
  • Acceleron Announces Presentation of ACE-083 Phase 1 Healthy Volunteer Data at the 14th International Congress on Neuromuscular Disease (Press)

US: Medical Devices

  • Report: Medtronic files for FDA approval of MiniMed 670G 'artificial pancreas' (MassDevice)
  • Insurer launches trial of Avinger's Pantheris atherectomy device (MassDevice)
  • Gore touts Viabahn endoprosthesis superiority over PTA in new study (MassDevice)
  • Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use (FDA)
  • Microbiology Devices Panel of the Medical Devices, Notice of Meeting (FDA)
  • Wearable Device Data Will Boost Real-World Evidence, Think Tank Says (Gray Sheet-$)
  • Mannkind taps medtech reps after Sanofi deal fails (MassDevice)

US: Assorted & Government

  • Lannett Sues FDA Over Temozolomide Capsules ANDA Approval Rescission (FDA Law Blog)
  • McKesson to Separate IT Segment in Venture With Blackstone (WSJ-$)
  • Acclarent Didn't Tell FDA About Adverse Events, Jury Told (Law360-$)
  • Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour (FDA Voice)
  • Latest Plan to Cut Medicare Drug Payments Leaves Senators Skeptical (NYTimes) (Medpage)
  • California gets go-ahead to vote on legalization of marijuana (Reuters)
  • 'Donnie Brasco' brother sues Zimmer (MassDevice)
  • AstraZeneca, iPR Launch Preemptive Lawsuit Against FDA Over Generic CRESTOR Approval (FDA Law Blog)

Upcoming Meetings & Events


  • CorMatrix lands CE Mark for CanGaroo surgical envelope (MassDevice)
  • Sweden's Handicare acquires mobility device developer Prism Medical (MassDevice)
  • AtriCure Receives CE Mark for the AtriClip® PRO2 Device (Press)
  • Eyenuk Announces CE Mark and Commercial Launch of EyeArt 2.0, the Second Generation of Its Fully Automated Diabetic Retinopathy (DR) Screening Software (Press)


  • Pharma associations in agreement on medical representatives in China (PharmaLetter-$)
  • Mithra Pharma signs LoI for Japanese, ASEAN Rights on Estetrol (BioSpectrum)
  • China Aiming To Slash Hospital Medical Cost Growth By Half (PharmAsiaNews-$)
  • Turkey Regulatory Update: HPV Vaccine, Device Tracking, Illegal Websites (PharmAsiaNews-$)


  • Karnataka pharma industry in wait & watch mode on Brexit impact (PharmaBiz)
  • India Seeks to Curb Dangerous Drug Cocktails (Medpage)
  • Glenmark bags FDA approval for new generic (BioSpectrum)


  • Sandoz Canada submission for biosimilar etanercept accepted for review by Health Canada (Biosimilar News)
  • Baxter Announces Health Canada Approval of AMIA Automated Peritoneal Dialysis System with SHARESOURCE Connectivity Platform (Press)


  • Zika Bill Is Blocked by Senate Democrats Upset Over Provisions (NYTimes)
  • White House chides Congress for failing to fund Zika (Reuters)
  • First baby with Zika-related birth defect microcephaly born in Florida (Reuters)
  • Zika outbreak: Monkey study suggests infection lasts longer in pregnancy than thought (CBCNews)

General Health & Other Interesting Articles

  • Pelvic Exams May Not Be Needed (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

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

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