Regulatory Recon: EMA Issues New Safety Recommendations for Zydelig, US-EU Mutual Inspections Near Reality (18 March 2016)

Posted 18 March 2016 | By Michael Mezher 

Regulatory Recon: EMA Issues New Safety Recommendations for Zydelig, US-EU Mutual Inspections Near Reality (18 March 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 FDA rejects Eagle Pharma's blood thinner (Reuters) (Press)
  • AngelMed Cardiac Monitor Panned At FDA Panel Over Clinical Trial Concerns (Gray Sheet-$) (MedpageToday)
  • Scientists discover non-opioid pain pathway in the brain (NIH)
  • Biden Names Leader for 'Moonshot' Cancer Campaign (NYTimes)
  • Accuracy Concerns on Testing Device for Blood-Thinning Drug (NYTimes)
  • Altered Mosquitoes Quietly Tested in the US (MIT Technology Review)

In Focus: International

  • EMA Recommends New Safety Measures for Zydelig (EMA)
  • What we Can Learn From Valeant's Wreckage (In the Pipeline)
  • US-EU Mutual Reliance On Drug Facility Inspections Nears Reality (Pink Sheet-$)
  • Guinea says two people tested positive for Ebola (Reuters)
  • NICE promises UK to lead Europe for cancer drug approvals (PM Live) (BioCentury)
  • Indian govt set to ban 1,200 fixed-dose combination drugs, reports (Pharmafile)
  • IMDRF Tackles Confusion Over Clinical Evidence Expectations for Device Software (SCRIP-$)
  • Colombian Regulators Now Consider Medical Displays Medical Devices (Emergo)

US: Pharmaceuticals & Biotechnology

  • Drug makes stem cells become 'embryonic' again (MNT)
  • Pursuit of a perfect insulin (Nature)
  • Valeant Jitters Infect Specialty Drug Sector (WSJ)
  • FDA Reverses Position On Fabre-Kramer's Gepirone, Clearing Way For Approval (Pink Sheet-$)
  • Orexigen's actions in gaining approval for obesity drug Contrave showed a 'real breakdown' in process, says former FDA senior official (PharmaLetter-$)
  • The SCIO Concept: How to Conduct Cost-Effective Clinical Trials (GxP Lifeline)
  • FDA Adds Patient Engagement Advisory Committee to standing advisory committees' regulations (FDA)
  • Revisiting a predictor of failure in the post-Celator world (EP Vantage)
  • Beware The 'Pitchforks,' Pharma (SCRIP-$)
  • Will Drones Reshape Clinical Trials? (Geeks Talk Clinical)
  • No role for paracetamol in treating pain in osteoarthritis (OnMedica)
  • Cat stem cell trial could lead to human treatments (Reuters)
  • Clinical research is wasted when systematic reviews fail to provide a complete and up-to-date evidence synthesis (MNT)
  • Pharmacovigilance for mAbs (GaBI)
  • Gilead cancer boss departs after safety concerns halt Zydelig trials (Pharmafile)
  • New dates for two FDA diabetes panels (BioCentury)
  • Kite Pharma, Roche to co-develop two new treatments for non-hodgkin lymphoma (Pharmafile)
  • New Insights From An Old Drug: Carbenoxolone, Huntington's Disease And Alcoholism (Start Up-$)
  • What Science Tells Us Can Affect Our Risk Of Alzheimer's Disease (Forbes)

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

  • Priority Review for Elite's abuse-deterrent opioid (BioCentury)
  • GSK's Advair Diskus achieves primary endpoint in LABA safety study (EPR)
  • Allergan files ANDA for generic version of Celgene's breast cancer treatment (Pharmafile) (EPR)
  • FDA approves Breckenridge's generic of Pfizer's anti-epilepsy drug (Pharmafile)
  • PixarBio Corporation Announces USFDA OPD Submission of NeuroRelease SCI for Orphan Drug Designation for Spinal Cord Injury (Press)
  • FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder (Press)
  • First patient dosed in Halozyme's PEGPH20 pancreatic cancer trial (EPR)
  • Novimmune's rare immune system disorder candidate NI-0501 gets Breakthrough status (PharmaLetter-$)

US: Medical Devices

  • Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue (FDA)
  • Integrating usability engineering into your medical device design process (MassDevice)
  • FDA 510(k) Clearance Granted to PneumaCare's Ground-breaking Thora-3DI Product for Non-contact Respiratory Measurement (Press)
  • CorMatrix® Cardiovascular, Inc. Treats First Patient in Its US Clinical Study for CorMatrix ECM Tricuspid Valve at Franciscan St. Francis Health Indianapolis, IN (Press)
  • CorMatrix launches US tricuspid valve device trial (MassDevice)

US: Assorted & Government

  • One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable? (Health Affairs Blog)
  • A Novel Way To Think About Primary Prevention, Death, And Statins (CardioBrief)
  • Oregon passes biosimilars substitution law (GaBI)
  • US FTC issues amicus brief on reverse-payment agreement involving GSK and generics (PharmaLetter-$)
  • How Medicare Drug Plans Hope To Follow Private Sector Lead (KHN)
  • CDC Guidelines Prescribe Controls on Opioid Therapy (FDA Law Blog)
  • J&J Hit With $498M Verdict In 2nd Pinnacle Bellwether Trial (Law360 1, 2-$) (NYTimes)
  • NY Doc Convicted For Role In Massive Oxycodone Pill Ring (Law360-$)
  • Zubik v. Burwell, Part 2: The Religious Objectors Who Cried Wolf (Harvard Bill of Health)
  • New Federal Employee Drug Screening Guidelines to Include Opioid Testing (Harvard Bill of Health)

Upcoming Meetings & Events


  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016 (EMA)
  • GSK break-up? Don't bank on it, says drugmaker's outgoing boss (Reuters)
  • PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease (EMA)
  • Welsh gov overrules NICE rejection of Celgene's pancreatic cancer drug (PharmaTimes)
  • Drug Makers To Prepare For Pharmacovigilance Reforms In Russia And Other EAEU Countries (SCRIP-$)
  • Update on the EUnetHTA JA2 deliverables: methodological guidance (EUnetHTA)
  • sugarBEAT Continous Glucometer Cleared in Europe (medGadget)


  • Former Roche Execs Given Jail Sentences In Turkey (PharmaAsiaNews-$)
  • Toshiba deals medical biz to Canon for $5.9B as U.S. authorities launch accounting probe (MassDevice) (Gray Sheet-$)
  • SRS Medical wins Korean clearance for Spanner stent (MassDevice)


  • ANALYSIS: Deciphering Trulicity's Indian Premium Price Strategy (PharmaAsiaNews-$)
  • Kerala HC gives chemists 2 more weeks to return 344 banned drugs (Economic Times)
  • Delhi HC stays ban on drugs of Wockhardt, Glaxo and Griffon (Economic Times)
  • Lobby groups of pharmaceutical companies considering petition against drug ban (Economic Times)
  • Torrent Pharma gets establishment nod from USFDA (Economic Times)
  • Aurobindo gets final USFDA nod for pre-surgery sedation drug (Economic Times)
  • We've been fair in assessing banned drugs, says Chandrakant Kokate (Economic Times)
  • Glenmark gets tentative nod from USFDA for epilepsy drug (Economic Times)
  • Is India ready to use only generics? (GaBI)
  • Health ministry asks industry to nominate members by March 31 for drafting MvPI guidance document (PharmaBiz)
  • Strides Shasun acquires Australian and Kenyan generics makers (GaBI)
  • Panel recommends continued use of PET for pharma packaging as no evidence to ban (PharmaBiz)
  • 344 FDC ban by govt to impact 3.1 % of pharma retail market (PharmaBiz)


  • Canada Consults On Disclosure Of Confidential Info On Approved Products (Clinica-$) (Focus)
  • International clinical trials, including trials in Canada, are being stopped due to serious adverse events with the drug Zydelig, in combination with other cancer drugs (Health Canada)

Other International

  • Angola's yellow fever death toll rises to 158: WHO (Reuters)

General Health & Other Interesting Articles

  • A New Front in the War on Doping (WSJ)
  • New Study Seeks to Use Deep Learning to Detect Heart Disease (WSJ)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles