Regulatory Recon: NCI Researchers Slow to Report Trial Deaths to FDA After Delay, Merck Gets Approval for C. diff Drug (24 October 2016)

Posted 24 October 2016 | By Michael Mezher 

Regulatory Recon: NCI Researchers Slow to Report Trial Deaths to FDA After Delay, Merck Gets Approval for C. diff Drug (24 October 2016)

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

In Focus: US

  • FDA And CMS Parallel Reviews Of Devices To Continue (Focus)
  • GSK files potential $1 billion shingles vaccine for US approval (Reuters) (Fierce) (Press)
  • The Pharma C.E.O. Who Wants to Lower Drug Prices (NYTimes)
  • Inside big pharma's fight to block recreational marijuana (The Guardian)
  • The trials of Juno  (The Economist)
  • Califf: Nothing Prohibits FDA From Using Real-World Evidence In Decisions (IHP)
  • Congressman calls for probe into Valeant's pricing of lead poisoning drug (STAT)
  • National Cancer Institute Says Researchers Didn't Quickly Tell FDA After Two Deaths in a Lymphoma Study (WSJ) (Washington Post)
  • ICER council votes on effectiveness, value of NSCLC therapies (Healio)
  • Taking the initiative in healthcare: Will California voters cap drug prices? (Modern Healthcare)
  • After delay, Merck gets US approval for C. diff drug (PMLive) (PharmaTimes) (Press)
  • Cigna ends preauthorization requirement to treat opioid addiction (Reuters)
  • EpiPen Shows A Path To Solve The Bigger Drug Pricing Challenge (Forbes)
  • The Unfortunate Reality Of A Rising Rate Of Breast Cancer (Forbes)
  • Inovio Announces FDA Request for Additional Information For Phase III Program; Trial Initiation Delayed (Press)
  • New Listeria fears spotlighted as Aduro's CRS-207 is slapped with partial hold (Endpoints) (Press)

In Focus: International

  • European Commission Explores The Future Of HTA Cooperation (Focus)
  • ICH Proposes Two New Guidelines (Focus)
  • Polio vaccine makers failing to make enough doses: WHO experts (Reuters)
  • The Americas Celebrate 25 Years Without Polio (WHO)
  • Lawsuit over cervical cancer vaccines to drag on as health ministry fights on (Japan Times)
  • Colombian pharma market to break $7 billion by 2020 (Pharmafile)
  • Service Gradually Restarts at BASF Plant in Ludwigshafen (PharmTech)
  • India Supreme Court backs NPPA on capping drug prices Economic Times)
  • French Supreme Court upholds Sanofi's generic denigration fine (National Law Review)
  • Biocon Confident As First Biosimilars Seen Hitting Europe In Early 2018 (SCRIP-$)
  • Manufacturer information data quality failings identified by Swissmedic (PharmaLetter-$) (SwissMedic)
  • China FDA official views new drug clinical trial data verification (PharmaLetter-$) (CFDA - English)

US: Pharmaceuticals & Biotechnology

  • Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval? (FDA Law Blog)
  • GSK exits U.S. market with its HPV vaccine Cervarix (Fierce)
  • Next Generic Drug User Fee Round Will Tie Fees To Approved Applications (IHP)
  • Researchers Propose a Flexible Method for Gene Therapy Manufacture (PharmTech)
  • GPhA SVP David Gaugh's Statement at GDUFA II Public Meeting (GPhA)
  • The little girl who battled a brain tumor, featured in a Washington Post story, has died (Washington Post)
  • USA signs cancer research pact with Cuba (PharmaLetter-$)
  • Researchers Take First Steps Toward A Preventative Alzheimer's Pill (Forbes)
  • A Safe And Legal Moneymaker: Did You Return Your Unused Pills Today? (Forbes)
  • Got a presidential #debateheadache? GSK's Excedrin remedy tweets explode on Twitter (Fierce)
  • Upcoming events – Sarilumab's date with the FDA and more peanut data from DBV (EP Vantage)
  • Angina Med Mix-up Leads to Recall (MPR)
  • Price-hiking Concordia CEO heads for the exit, drawing parallels with Valeant (Fierce)
  • Solid drug nanoparticles could improve delivery of HIV therapies (MassDevice)
  • Gold nanoparticles hold promise for pancreatic cancer treatment (MassDevice)

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

  • aTyr Pharma Receives FDA Fast Track Designation for Resolaris™ to Treat Facioscapulohumeral Muscular Dystrophy (FSHD) (Press)
  • Gilead Presents Results from Phase 3 Studies Evaluating Switching to Descovy® (FTC/TAF)-Based Regimens from Truvada® (FTC/TDF)-Based Regimens (Press)
  • U.S. Food and Drug Administration Accepts for Priority Review the Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Patients With Advanced Form of Bladder Cancer (Press)
  • FDA Approves Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Advanced Prostate Cancer (Press)
  • Solid Biosciences Granted U.S. and E.U. Orphan Drug Designations for Lead Gene Therapy Candidate for Duchenne Muscular Dystrophy (Press)
  • The US FDA Granted Orphan Drug Designation to Yisheng Biopharma's Biological Product for Hepatocellular Carcinoma (Press)
  • Cidara Therapeutics Announces Data from Studies of Novel Antifungal CD101 to be Presented at ACCP and IDWeek Annual Meetings (Press)
  • Mersana Announces FDA Clearance of IND Application for Lead Antibody-Drug Conjugate XMT-1522 (Press)

US: Medical Devices

  • Merit Medical reveals U.S. Justice Dept. subpoena(MassDevice)
  • Heater-cooler issue expands to snare Maquet (MassDevice)
  • EQUIP: Enhancing Quality Using the Inspection Program (FDA)
  • Report: Trump would repeal medical device tax, Clinton noncommittal (MassDevice)
  • Irhythm rocks the Nasdaq (EP Vantage)
  • St. Jude Medical Announces Data to be Presented as Late-Breaking Clinical Trials and Highlights Its Latest Cardiovascular Portfolio at the 2016 TCT Conference (Press)
  • Class 1 Device Recall Fortify, Unify, Assura, including Quadra (FDA)
  • HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues (FDA)
  • FDA approves Jarvik Heart trial for pediatric cardiac assist device (MassDevice)
  • Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System (FDA)
  • Alere shareholders OK $6m Abbott buyout (MassDevice)
  • Medtronic recalls Heartware HVADs over driveline contamination issues (MassDevice)
  • Roche Receives FDA Approval for Cobas MPX Test (GenomeWeb) (Press)
  • FDA Clears ORTHO VISION(R) Max Analyzer for High-Volume Transfusion Medicine Labs (Press)
  • FDA clears pediatric spine implants from Medicrea (MassDevice)

US: Assorted & Government

  • Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation (Drug and Device Law)
  • Drugmaker Takes Flanax Trademark Case To Supreme Court (Law360-$)
  • Fed Circ again upholds patent win for Medtronic's Cardiocom (MassDevice) (Patent Docs)

Upcoming Meetings & Events


  • Scottish clinical guidelines on patient pressure area care published (Harvard Bill of Health)
  • La Jolla Pharmaceutical Company Receives Positive Opinion from European Orphan Committee for LJPC-401 (Press)
  • In Ireland, 948 medicines price cuts now delivering 78 million euros savings, IPHA confirms (PharmaLetter-$)


  • CDSCO Recalls Infusion Device Over Shelf Life Issues (CDSCO 1, 2)
  • India's Tata gives UCSD $70M in hot area of genetics (San Diego Tribune)
  • Wanbury under lens for illegal export of diabetes drug (Economic Times)
  • Sun Pharma completes divestment of 7 brands to RPG (Economic Times)


  • Medtronic secures Health Canada license for MiniMed 630G system (MassDevice)
  • Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention (Health Canada)
  • Summary Safety Review - Incretin-Based Therapies - Assessing the Potential Risk of Pancreatic Cancer (Health Canada)


  • CDC announces supplemental funding opportunity for continued Zika response in 2017 (CDC)

Other International

  • WHO Issues Best Practice Guide For Counterfeit Drug Detection (Pink Sheet-$)
  • Opium crops spread in Afghanistan as Taliban gains ground, U.N. says (Reuters)

General Health & Other Interesting Articles

  • Type 1 diabetes often comes with other autoimmune diseases (Reuters)
  • Pokemon Go Increased U.S. Activity Levels by 144 Billion Steps in Just 30 Days (MIT Technology Review)

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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