Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Hamburg Hits Back at Zohydro Criticism (21 April 2014)

Regulatory Reconnaissance: Hamburg Hits Back at Zohydro Criticism (21 April 2014)

Posted 21 April 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

Your Editor is on vacation today and will return to normal coverage on Tuesday, 22 April 2014.

In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Hamburg Responds Directly to Zohydro Criticism (BioCenturyTV)
  • FDA approves Merck & Co's Ragwitek (Pharma Times) (BioCentury) (SCRIP-$) (FDA) (Merck) (Reuters) (MedPage Today)
  • FDA Approves Arzerra for Chronic Lymphocytic Leukemia (DD&D) (Pink Sheet-$) (BioCentury) (SCRIP-$) (GSK)
  • Biosimilars, bio-differences: Breakdown of US State substitution laws (BioPharma Reporter)
  • Should Patents On REMS Distribution Restrictions Be Banned? (Pink Sheet-$) (NEJM)
  • What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes (Pink Sheet-$)
  • FDA Approves Stronger Warning Labels For Opioids (Law 360-$)
  • FDA Studying Best Ways To Do Advertising Studies (Pink Sheet-$) (Law 360-$) (FDA)
  • Warning and NOV Letter Summary - 1st Quarter 2014 (FDA)
  • Court won't block Teva rivals (SCOTUSblog) (Law 360-$) (Teva) (Reuters) (SCRIP-$)
  • FDA Seeks Compounding AdComm Members (FDA)
  • Component Testing Gains Prominence in 2012-2014 Drug Product GMP Warning Letters (IPQ-$)
  • QRxPharma's Moxduo Doesn't Offer Respiratory Safety Advantage, FDA Finds (Pink Sheet-$) (BioCentury) (SCRIP-$)
  • GDUFA's Perfect Storm: Approvals Drop, Submissions Jump (Pink Sheet-$) (2-$)
  • FDA committee to discuss olaparib (BioCentury) (FDA)
  • Impax Can't Shake Drug Quality-Control Securities Action (Law 360-$)
  • Digital Health Coalition Urges FDA to Launch a Social Media "Laboratory" to Ensure Adequate Guidance Progress (Pharma Marketing)
  • Is FDA Seeing What We're Seeing with Its Old-School Web Browsers? Klick Health Wants to Know (Pharma Marketing)
  • Rx Drug Promotion Risks: Value Claims, Getting Close To Patients (Pink Sheet-$)
  • Smaller trials and more post-marketing surveillance: the answer for drug development? (SCRIP-$)
  • Bill Would Form Antimicrobial Resistance Task Force (House)
  • PCAST Looks At FDA Policy, Role Of Animals In Antibiotic Resistance (IHP-$)
  • UCSF study finds codeine often prescribed to children, despite available alternatives (Press) (NBC) (WaPo)
  • Solicitor General: False Advertising Claims Not Broadly Precluded By FDA Law (IHP-$)
  • Generic Celebrex is coming (MM&M)
  • Hospira Recalls Seven Lots of Propofol Injectable Emulsion (PharmPro) (FDA)
  • Hospira Announces Voluntary Nationwide Recall of One Lot of 1% Lidocaine HCI INjection, USP, Due To Visible Particulates (FDA)
  • Cubist Pharmaceuticals Recalls One Lot of CUBICIN 500 mg in 10 mL Single Use Vials (Press) (FDA)
  • Novartis recalls some Ritalin over packaging issue (Fierce)
  • India's Glenmark pulls 2,900 bottles of ulcer drug in U.S. (Reuters)
  • Vaccine Safety In Pregnancy Among Possible Mini-Sentinel Projects (Pink Sheet-$)

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

  • Sarepta's DMD Drug Eteplirsen to Apply for FDA's  Accelerated Approval Pathway (Forbes) (Press) (Reuters) (Fierce) (Bloomberg)
  • FDA Grants Fast Track Status To Amgen Heart Failure Drug (Forbes)
  • Cubist Announces Submission of New Drug Application for Investigational Antibiotic Ceftolozane/tazobactam (Press)
  • Emergent BioSolutions Receives Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease (Press)
  • Ivabradine Fast Tracked for Chronic HF (DD&D)
  • FDA lifts its hold on Juno's cutting-edge cancer drug after deaths trigger delay (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Bill for California statewide disposal law lands in the trash (Fierce)
  • Cancer drugs: Too expensive to compare? (Modern Healthcare)
  • Massachusetts Looks to Boost Use of Abuse-Deterrent Drugs (MA)
  • AbbVie urges U.S. court to avoid gay rights issue in HIV drug case (Reuters)
  • UnitedHealth already seeing effects of Gilead's pricey hepatitis C drug (MarketWatch)

US: Medical Devices

  • FDA Warns Against Power Morcellators For Uterine Fibroid Surgery (Gray Sheet-$) (Mass Device) (JAMA) (AP) (Law 360-$) (FDA) (WSJ-$) (WaPo) (Reuters) (NYTimes) (MedPage Today) (Bloomberg)
  • GUDID Submission Methods: Which One's Right for You? (MDDI)
  • St. Jude Warning Letter Updates: CRM Facility Reinspected; Neuro Plant Awaits FDA Visit (Gray Sheet-$)
  • FDA helps people close eyes - with weights (The Hill) (FDA)
  • FDA Committee to Discuss Maestro Rechargeable Neuromodulator (FDA)
  • Covidien lands FDA OK for camera-equipped feeding tube (Mass Device) (MedGadget)
  • When Medical Device Companies Bend the Rules (MDDI)
  • Edwards Says Valve Ban Should Stand, Citing Scare Tactics (Law 360-$)
  • Next-Generation Sequencing Technology, Data Formats Standardization and Promotion of Interoperability Protocols; Public Workshop (FDA)

US: Dietary Supplements

  • Inspection Data Show "Reality" Of Supplement GMP Enforcement (Tan Sheet-$)
  • Crudely Misogynistic Male Supplement Gets Nailed By FDA (Forbes)
  • CRN: FDA's IND Guidance Could Harm Supplement Innovation (NPI) (Tan Sheet-$)

US: Assorted And Government

  • U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009 (CCR)
  • FDA Works with China to Ensure Medical-Product Safety (FDA)
  • NIH Awards Scripps $2M to Design a Better Diabetes Drug Model (DD&D)
  • General Mills: If You Clip This Coupon, You Can't Sue Us! (Atlantic)
  • SCRIP Capitol Capsule (SCRIP-$)



  • Row over clinical trial as 254 Indian women die (India Times)

Japan & China

  • CFDA Names New Testing Agency Head (PharmAsia-$)
  • China backs away from price controls on basic drugs (Reuters)

Other International

General Regulatory And Interesting Articles

  • The Calculus of Cures (NEJM)
  • A $50 3D-Printed Prosthesis Compared To A $42,000 Myoelectric Prosthesis (Digg)
  • Scientists on Track to Assemble 3D Printed "Bioficial" Heart (MedGadget)
  • Certara buys CRO Synchrogenix as regulatory writing sees more outsourcing (Outsourcing Pharma)
  • Checking baby poop color is important, and there's an app for it (WaPo)
  • Tiny new medical devices could soon be fueled by, of all things, human spit (WSJ-$)

Regulatory Reconnaissance #301 - 21 April 2014

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.

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