Regulatory Recon: FDA Approves New Obesity Device Novo Diabetes Drug Cuts Heart Risks by 13 Percent (14 June 2016)

Posted 14 June 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves New Obesity Device Novo Diabetes Drug Cuts Heart Risks by 13 Percent (14 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

  • US to invest $200 million to shorten organ transplant wait lists (Reuters)
  • Novo Diabetes drug cuts heart risks by less-than-hoped 13% (Forbes) (Reuters)
  • FDA Approves AspireAssist Obesity Device (FDA)
  • Shire buys bowel drug rights from Pfizer (Reuters)
  • Pharma's secret weapon to keep drug prices high (STAT)
  • KemPharm says FDA does not approve its painkiller (Reuters) (BioCentury)
  • Democrats urge an end to curbs on blood donations from gay men (Reuters)
  • The Mystery of ALS Patients Who See Improvement (WSJ-$)
  • Obama administration signs historic health agreement with Cuba(CNBC) (STAT)
  • FDA Issues New Guidance on Osteoporosis Drug Development (Focus)
  • Clinical Trial Expert's Deep Dive Into The Important New Liraglutide Trial (CardioBrief)
  • ASCO Reacts to Biden's Moonshot Pitch (Medpage)
  • Prescription Drug Shortages: Data Limitations In An Era Of Big Data (Health Affairs Blog)
  • Teva halts sales of migraine patch on reports of burns, scars (PharmaTimes) (Pink Sheet-$)
  • The legalization of off-label promotion: Vascular Solutions beat the FDA and what their victory means for medtech (MassDevice)

In Focus: International

  • French prosecutors open probe into fatal drug trial (Reuters)
  • GSK Vaccines Chairman Moncef Slaoui to Retire Next Year (Bloomberg) (Reuters)
  • The Mesoblast dream is over (EP Vantage)
  • CDSCO working towards drafting new Drugs & Cosmetics Act, 2016 (PharmaBiz)
  • Pfizer-Backed Ziarco Said to Mull Sale of U.K. Biotech Firm (Bloomberg)
  • TGA Issues Hazard Alert for Medtronic Deep Brain Stimulation Devices (TGA)
  • What Did Big Pharma Earnings Say About China Growth? (PharmAsiaNews-$)
  • Four new medicines OK'd for use by NHS Scotland (PharmaTimes)
  • WHO Tackles Submission Of Insufficient Or False Data By Pharma (SCRIP-$)
  • The Bayer-Monsanto Deal Through An Antitrust Lens (Law360-$)
  • Finland's Faron licenses Traumakine Korean rights to Pharmbio (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Mesoblast regains full rights to stem cell heart failure treatment (Reuters)
  • Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits (NIH)
  • Changing the Subject (Part 5): A Lesson From The Past (RPM Report-$)
  • FDA Comments Deeming Regulation (FDA Atty)
  • Dizzy and Disoriented, With No Cure in Sight (NYTimes)
  • Eleven Biotherapeutics soars on eye drug deal with Roche (PharmaLetter-$)
  • Infinity Closes Research Ops as Blood Cancer Drug Comes Up Short (Xconomy)
  • More Than 50% Of Patients Prescribed Opioids Have Leftover Pills (Forbes)
  • Valeant shares rise after big CEO stock purchase (CNBC)
  • FDA to discuss Amgen's Humira biosimilar (BioCentury)
  • Harnessing the Power of Collaboration: Metrics & Measurement (FasterCures)
  • How Patient Groups Have Begun to Influence the Value and Coverage Debate (FasterCures)
  • Filing in ACE for FDA: Compliance Dates and Common Errors  (Registrar Corp)

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

  • Merck's Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus (Press) (BioCentury)
  • Revance to stop developing crow's feet drug after trial failure (BioCentury) (Reuters)
  • Zafgen's Beloranib Trial Shows Significant Improvements In Weight Loss (RTT News)
  • Espero Pharmaceuticals Receives FDA Approval for GONITRO (Nitroglycerin) Sublingual Powder (Press)
  • PharmaMar Announces the Start of a Pivotal Study With plitidepsin in angioimmunoblastic T-cell lymphoma (Press)
  • Marathon Pharmaceuticals Announces Submission of Deflazacort New Drug Application to the FDA (Press)
  • twoXAR Completes Initial Studies of New Rheumatoid Arthritis Drug Candidates (Press)
  • The Medicines Company Announces Initiation of Phase II Study for its Investigational Anesthetic, ABP-700 (Press)
  • Taiga Biotechnologies Awarded Orphan Drug Designation for Stem Cell Therapy (Press)
  • Aerpio Therapeutics Reports Peer-Reviewed Publication of Positive Clinical Results from the Phase 2a Study of Lead Candidate, AKB-9778, in Diabetic Macular Edema (DME): The TIME-2 Trial (Press)
  • Aimmune Therapeutics Announces Phase 2 Extended Maintenance Data Supporting Safety and Tolerability Profile of AR101 for Peanut Allergy (Press)

US: Medical Devices

  • Boston Scientific updates warnings for pelvic mesh products (MassDevice)
  • FDA Plans For Private-Payer Meetings Ahead, But Roadblocks Remain (Gray Sheet-$)
  • Terumo buys Sequent Medical for $280m (MassDevice)
  • ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements (Greenlight Guru)
  • Philips Healthcare Eyes Acquisitions Worth Over $1b (MedDeviceOnline)
  • Medtronic touts 'closed-loop' insulin management system | American Diabetes Assn. 2016 Scientific Sessions (MassDevice)
  • Oversight board OKs trial for Echo Therapeutics non-invasive CGM (MassDevice)
  • Ethicon study reports bariatric surgery as effective treatment for Asian Indian type II patients | American Diabetes Assn. 2016 Scientific Sessions (MassDevice)
  • Class I Recall: CareFusion AVEA Ventilator (FDA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)

US: Assorted & Government

  • It's Not The Same Old JPML (Drug and Device Law)
  • Pricing Bills Are Popping Up Everywhere – Review of State Prescription Drug Pricing Proposals (Policy and Medicine)
  • Edwards Lifesciences escalates TAVR patent war with Boston Scientific (MassDevice)
  • Supreme Court grants Stryker another chance at $228m patent award from Zimmer (MassDevice)

Upcoming Meetings & Events


  • Boehringer Ingelheim to launch production in Russia (PharmaLetter-$)
  • Ad hoc expert audio conference on vaccine shortages (EC)
  • UK drug treatment of ADHD in children may have peaked (OnMedica)
  • Marketing authorisations granted in May 2016 (MHRA)
  • Parallel import licences granted in May 2016 (MHRA)


  • CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns (In-PharmaTechnologist)
  • Passage of GST Bill may help pharma sector to improve supply chain efficiency: Pednekar (PharmaBiz)
  • India's Risk-Based Inspection Plan: Well Begun? (PharmAsiaNews-$)


  • WHO convenes 3rd meeting of Emergency Committee on Zika and observed increase in neurological disorders and neonatal malformations (WHO)

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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