Regulatory Recon: Health Officials Press for Zika Funding, Senate Passes Opioid Bill (11 March 2016)

Posted 11 March 2016 | By Michael Mezher 

Regulatory Recon: Health Officials Press for Zika Funding, Senate Passes Opioid Bill (11 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

  • Health Officials Urge Congress to Fund Zika Research (NYTimes)
  • Real World Evidence: Can it Support New Indications, Label Expansions? (Focus)
  • Parker Hannifin's Robotic Exoskeleton Gets FDA OK for Personal Use (WSJ-$)
  • Senate Passes Bill to Fight U.S. Opioid Epidemic (WSJ-$)
  • Sanofi Drug Beats AbbVie's Blockbuster Humira in Human Trial (Bloomberg)
  • Drug Tests Take Cue From Travel Site to Fix Industry Headache (Bloomberg)

In Focus: International

  • WHO Draft Guidelines On Biosimilar MAbs: Extrapolation 'A Goal' Of Development Program (SCRIP-$)
  • ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial (Focus) (BioCentury)
  • India's Supreme Court Denies Petitions Challenging CDSCO (Focus) (Reuters)
  • Medecins Sans Frontieres files to block Pfizer patent on pneumonia vaccine in India (Reuters)
  • Swiss and Indian regulators trying to determine how fake Harvoni reached Israel (In-PharmaTechnologist)
  • Japan's Biopharmas Respond to Price Cuts with Plans for Innovation, Expansion (Thomson Reuters)
  • China negotiating deep drug discounts (BioCentury)

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US: Pharmaceuticals & Biotechnology

  • PhRMA's Ubl unveils agenda (BioCentury) (SCRIP-$) (Pink Sheet-$)
  • Tufts CSDD Assessment of Cost to Develop and Win Marketing Approval for a New Drug Now Published (Tufts)
  • FDA's Antimicrobial Resistance Monitoring Team Wins Government Award to Design Public Health Surveillance Mobile App (FDA)
  • Years of taking popular diabetes drug tied to risk of B12 deficiency (Reuters)
  • Patient-Report Outcomes: What Percentage Of Claims Get Approved? (Cutting Edge Info)
  • Pioneering apoptosis-targeted cancer drug poised for FDA approval (Nature)
  • 2015 Porzio Life Sciences Year-End Report – Navigating the Regulatory Landscape (Porzio)
  • RBM is Advancing: 3 Keys in Planning (Bioclinica Blog)
  • What Does Risk-Based Monitoring Mean For Clinical Trials? (Geeks Talk Clinical)
  • Existing drugs could fight lethal viral infections (Pharmaceutical Journal-$)
  • Corporate Equity Investing In Biotech: Enriching For Success (Forbes)
  • Teva issues US recall of amikacin sulfate injection due to glass identified in vials (Pharmafile)
  • Researcher develops strategy to identify antimicrobial drugs that tackle drug-resistant pathogens (Pharmafile)
  • Failed Alzheimer's Drug To Get Another Shot, If Investors Pony Up (Exome)

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

  • Vericel's heart drug successful in mid-stage study (Reuters)
  • Biothera Pharmaceuticals to Present Its Phase 2 Cancer Immunotherapy Data at the 23rd International Molecular Medicine Tri-Conference (Press)
  • Novartis stops PhIII trial of Genmab's Arzerra after buying rights from GSK (Fierce)
  • Strike 3: Struggling Xoma jettisons its lead drug after (another) PhIII failure (Fierce)
  • Alzheon Announces Efficacy Analyses of Prior Tramiprosate Phase 3 Studies Showing Clinically Meaningful Benefits on Key Clinical Endpoints in Alzheimer's Disease Patients with APOE4 Genotype (Press)
  • ADC Therapeutics Doses First Patient in Phase I Trial of ADCT-402 in CD-19 Positive B-cell Non-Hodgkin Lymphomas (Press)
  • Two-drug combo shown to significantly shrink breast cancer in days (Pharmafile)

US: Medical Devices

  • Cochlear wins FDA clearance for Baja 5 SuperPower sound processor (MassDevice)
  • Boston Scientific Receives U.S. FDA Approval For Blazer Open-Irrigated Catheter (Press) (MassDevice)
  • US Dept. of Defense clears Philips digital pathology platform (MassDevice)
  • Abbott to launch 1,000+ patient trial to standardize traumatic brain injury testing (Fierce)

US: Assorted & Government

  • Valeant Settles One Legal Headache But Still Faces Congressional, DOJ Probes (Pink Sheet-$) (SCRIP-$)
  • Poor Generic Drug Label Can Be Put On Novartis, Court Says (Law360-$)
  • DOJ Attys Dish On Pharma, Device Fraud Landscape (Law360-$)
  • Oversize Drug Packaging Suits Are A 'Waste' For Plaintiffs (Law360-$)
  • If I Keep Asking You to Dance, Perhaps You'll Say Yes? Amgen Files a Third Patent Dance Lawsuit Against Sandoz (FDA Law Blog)
  • CMS Proposes Far-Reaching Pilot to Test Alternative Drug Payment Models Under Medicare Part B (FDA Law Blog)

Upcoming Meetings & Events


  • European Regulatory Roundup: Parliament Seeks More Responsible Use of Antibiotics (10 March 2016) (Focus)
  • Could Clearing The Blurred EU Regulatory Lines For Non-Medical Brain Stimulation Devices Open Pandora's Box? (Clinica-$)
  • Public consultation on the draft methodological reflection paper "Personalised medicine and co-dependent technologies, with a special focus on study design issues" (EUnetHTA)
  • NHS England launches antibiotic incentive scheme (PharmaTimes)
  • EU Medtech, Pharma See Limited Use Of HTA Reimbursement Template (SCRIP-$)
  • Marketing authorisations granted in February 2016 (MHRA)
  • Opdivo Reimbursement Rejected In Scotland (SCRIP-$)
  • Russia's serialization and track & trace system reviewed (Securing Industry)
  • EGA becomes Medicines For Europe (Biosimilar News)
  • EU revokes Tecfidera patent, Biogen says it will appeal (BioCentury) (Boston Business Journal)
  • Deciphering the EU clinical trials regulation (Nature)
  • InterScope wins CE Mark for EndoRotor endoscopic resection device (MassDevice)
  • Medtronic's Navigate lung trial enrolls 1st European patient (MassDevice)


  • No decision on Indian drug price control without pharma industry discussions, says minister (PharmaLetter-$)
  • Sun Pharma's Feb 2016 Recall From Halol, Gujarat Facility – Subject Of Dec 2015 Warning Letter (24 Insight) (Economic Times)
  • South Africa's Adcock in talks to sell part of its India business (Economic Times)
  • Dr Reddy's, TR-Pharm announce collaboration for 3 biosimilars (Economic Times)
  • Union govt's Mission Indradhanush expected to expand vaccinations to include rabies, cervical cancer & rotavirus (PharmaBiz)
  • Maha FDA asks for compliance reports regarding hospitals not forcing patients to buy from in-house pharmacy (PharmaBiz)

    Zika Virus

    • FDA Sends Letter to MD Biosciences Over Unapproved Zika Test (FDA)
    • Two U.S. soldiers in South America contracted, recovered from Zika: commander (Reuters)
    • How Best To Test For Zika Virus? (NPR)

    Other International

    • Consultation Deadline Nears For WHO's Clinical Evaluation Guidance For Vaccines (SCRIP-$)
    • Arab Health 2016 – bigger and better than ever (MassDevice)
    • Liberia shutters Red Cross amid inquest into Ebola spending (Reuters)

    General Health & Other Interesting Articles

    • FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers (FDA Voice)
    • Scientists find 'good' cholesterol can sometimes be bad (Reuters)

    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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