Regulatory Focus™ > News Articles > Regulatory Reconnaissance: AdComm Pans MoxDuo as Massachusetts Limits Zohydro (23 April 2014)

Regulatory Reconnaissance: AdComm Pans MoxDuo as Massachusetts Limits Zohydro (23 April 2014)

Posted 23 April 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Second Company Asks FDA to Reconsider Denial of NCE Exclusivity for Approved FDC . . . and to Stay Application of the Agency's New Interpretation (FDA Law Blog)
  • FDA 'breakthrough' scheme approves GSK biologic, but is it faster? (Biopharma Reporter)
  • Baxter Announces FDA Approval of ADVATE (Antihemophilic Factor [Recombinant]) with BAXJECT III Reconstitution System (Press)
  • FDA Advisers Vote Against Approving New Opioid Painkiller (NPR) (AP) (BioCentury) (MedPage Today) (Pink Sheet-$) (SCRIP-$) (Bloomberg)
  • Massachusetts Places New Restrictions on Zohydro (AP) (Zogenix)
  • Off Label Use Does Not Establish a False Claim (D&D Law)
  • Pradaxa, Xarelto, Eliquis: NOACs' Reversal a Key? (MedPage Today)
  • Oklahoma Limits Off-Label Abortion Drug Use (NYTimes)
  • Patients may have played a role in the FDA's stance on Sarepta (BioFlash)
  • Should Manufacturers Adopt Randomization Methods Under the DQSA? (RxTrace)
  • Perrigo Wants Hurry-Up On Delayed FDA Drug Rating (Law 360-$)
  • Sovaldi NDA Review Marred By Manufacturing Compliance Issues (PAM-$)
  • Collaboration and Medical Countermeasures: Furthering Regulatory Science (FDA)
  • Balancing the Prevention of Opioid Abuse and Appropriate Pain Management (FDA)
  • Hospira Announces Voluntary Nationwide Recall of One Lot of 0.25% Marcaine (Bupivacaine HCI Injection, USP), 10 ml, Single-Dose, Preservative-Free Vial Due to Visible Particulates (FDA)

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

  • AbbVie files NDA for oral, interferon-free treatment of hepatitis C (Pharma Letter-$) (DD&D) (Fierce) (BioCentury) (Pharma Times) (SCRIP-$)
  • FDA Grants Orphan Drug Designation for Bayer's Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis (Press)
  • Tolero Pharmaceuticals Receives FDA Orphan Drug Designation for Alvocidib for the Treatment of Acute Myeloid Leukemia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Only 1% of hepatitis C patients have received a life-saving, new and expensive drug (TIE) (NYTimes) (Fierce) (Bloomberg)
  • MIA In The War On Cancer: Where Are The Low-Cost Treatments? (ProPublica)
  • House Panel to Look at Issue of Opioid, Heroin Abuse (E&C)
  • Not all older adults want emergency stroke drug: study (Reuters)
  • Three More Charged in $80M Eli Lilly Heist in Connecticut (AP)

US: Medical Devices

  • Device to Shock Disabled for Behavior May Be Banned (Bloomberg)
  • FDA Wants New Methods of Identifying Patients Going into Shock (FDA)
  • Push For UDI Incorporation Into Claims Forms Met With Support, But Challenges (IHP-$)
  • FDA Establishes Regulatory Policies on Radiation Exposure in Computed Tomography and Fluroscopic Devices (FDA)
  • FDA clears Intuitive Surgical's single-site da Vinci Sp robotic surgery system (Mass Device) (Gray Sheet-$) (MedGadget)
  • In-Depth Look at 23andMe and its Founder, Anne Wokcicki (New York Mag)
  • Teleflex hit with FDA warning letter over respiratory devices (Fierce)
  • FDA Gives Latinas Tools to Fight Diabetes (FDA)
  • Medtronic begins U.S. IDE trial for Evera SureScan MRI-safe ICD (Mass Device) (Fierce)
  • Boston Scientific launches trial for Acuity X4, Reliance 4-Front leads (Mass Device)

US: Dietary Supplements

  • Hydroxycut Users Settle For Less In $14M False Ad MDL Deal (Law 360-$)
  • Is DSHEA a public relations problem for the sports nutrition sphere? (NI-USA)
  • Argument analysis: Justices skeptical of Coke's right to "cheat consumers" (SCOTUSblog)

US: Assorted And Government


  • EMA Provides Update on Joint Activities With FDA (EMA)
  • Roche's New breast cancer drug Kadcyla 'unaffordable' for NHS, Says NICE (OnMedica) (BioCentury) (Pharma Times) (SCRIP-$) (Pharmafile)
  • NICE backs two cancer drugs: Boehringer Ingelheim's Giotrif (afatinib) and Janssen's Velcade (bortezomib)  (PMLive) (Pharma Letter-$) (SCRIP-$) (SCRIP-$)
  • EMA Reflection paper on anthelmintic resistance (EMA)
  • EMA Updates GMP Q&A Guidance (EMA)
  • European Commission Grants Orphan Drug Designation to Soliris (Eculizumab) for the Prevention of Graft Rejection Following Solid Organ Transplantation (Press)
  • Ben Goldacre talks AllTrials at Imagining the Future of Medicine (AllTrials)


  • Pfizer complains about India's intellectual property regime again (India Times)
  • Indian Govt to further restrict manufacture, sale of oxytocin injection (PharmaBiz)

Japan & China

Other International

  • IMDRF Posts Procedural Documents (IMDRF)
  • Biocad's rituximab biosimilar approved in Russia (BioCentury)
  • Avedro Announces Canadian Approval for its KXL II Advanced Cross-Linking System (Press)

General Regulatory And Interesting Articles

  • Culture of Quality: The upper-level stratification that FDA is looking for must happen, but it cannot come from the kind of metrics that are being discussed (Pharma Manufacturing)
  • Saudi Arabia reports 11 new cases of MERS virus, first in Mecca (Reuters)

Regulatory Reconnaissance #303 - 23 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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