Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Will Purdue Solve FDA's Zohydro Problem? (12 March 2014)

Regulatory Reconnaissance: Will Purdue Solve FDA's Zohydro Problem? (12 March 2014)

Posted 12 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Purdue Pill May Force Zogenix's Rival Drug Off Market (Bloomberg)
  • FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014 (FDA)
  • Chimerix Agrees to Compassionate Use Exemption for 7-Year Old Cancer Survivor (CBS) (NBC) (Fierce) (Forbes) (Reuters) (BioCentury)
  • FDA allows marketing of first medical device to prevent migraine headaches  (FDA) (Cefaly) (WSJ-$) (MNT) (PMLive) (NBC) (AP) (Mass Device)
  • FDA Approvals of Innovative Devices Fell Off a Cliff in 2013 (MDDI)
  • Bid to Replace Pap Test Goes to FDA Panel (MedPage Today) (Gray Sheet-$)

In Focus: International

  • IMI pushes stakeholders to GETREAL in new €16m 'real clinical data' project (SCRIP-$) (BioCentury)
  • SMC recommends six products but rejects two for diabetes (SCRIP-$)
  • No price ceiling for rare disease drugs, say UK MPs in Survey (PMLive) (Pharma Letter-$) (Pharmafile)
  • French plan to allow use of Avastin in AMD on cost grounds (SCRIP-$)
  • CDSCO analysis reveals prevalence of substandard drugs in India (In-Pharma)

US: Pharmaceuticals/Biotechnology

  • Purdue Pill May Force Zogenix's Rival Drug Off Market (Bloomberg)
  • FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014 (FDA)
  • Chimerix Agrees to Compassionate Use Exemption for 7-Year Old Cancer Survivor (CBS) (NBC) (Fierce) (Forbes) (Reuters) (BioCentury)
  • The dying child vs. the biotech: Everybody loses (Fierce) (NBC)
  • FDA considers draft guidance on FDAMA Section 114 (CEA)
  • Geron: FDA Suspends Key Myelofibrosis Drug Due to Liver Safety Concerns (The Street) (Fierce) (Reuters) (Bloomberg)
  • Lanham Act Decision Suggests That Marketing Pursuant to ANDA Approval Does Not Preclude Liability When FDA Later Reverses Its Decision (FDA Law Blog) (Fierce)
  • U.S. FDA Gives Passing Grade To Ranbaxy Research Units (PharmAsia-$)
  • PhRMA Pans FDA Benefit-Risk Meeting, Saying it Missed the Mark (PhRMA)
  • Mallinckrodt plc Receives FDA Approval For XARTEMIS XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII) (Press)
  • Reed Smith Atty's Widow Gives Generic-Drug Plaintiffs Hope (Law 360-$)
  • Propoxyphene Painkillers Formally Withdrawn (FDA)
  • US FDA's "safety by design" push driving pill coating trends says Colorcon (In-Pharma)
  • Opinion: Look-alike pills endanger everyone (Dallas News)
  • Some Thoughts on the FDA's Latest Off-Label Guideline (D&D Law)
  • Mercatus Center Files Comments on Generic Drug Labeling Rule (Mercatus)
  • Biosimilar Patent Strategy: Follow-Ons May Target Secondary, Third Party Patents (Pink Sheet-$)
  • How They Won It: Kaye, Munger Ward Off Pay-For-Delay Case (Law 360-$)
  • Quote: "Drug development would be so much easier if people didn't have livers" (Twitter)

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

  • Oxigene doubles on Zybrestat-Avastin ovarian cancer results (SCRIP-$) (Reuters)
  • Pfizer Presents Detailed Results From Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13 (Press)

US: Pharmaceuticals and Biotechnology: General

  • Doctor Payments on the Decline (ProPublica)
  • CVS probed in alleged loss of painkillers (LA Times)
  • Medical groups question price of new hep C drug (AP)
  • FTC Says It Can Place HSR Act Restrictions On Drug Cos. (PhRMA)
  • Baxter Asks High Court To Mull USPTO's Verdict-Nixing Power (Law 360-$)
  • With Solvadi in the mix, the FDA's class of 2013 is set for chart-busting sales (Fierce)

US: Medical Devices

  • FDA allows marketing of first medical device to prevent migraine headaches  (FDA) (Cefaly) (WSJ-$) (MNT) (PMLive) (NBC) (AP) (Mass Device)
  • FDA Approvals of Innovative Devices Fell Off a Cliff in 2013 (MDDI)
  • Bid to Replace Pap Test Goes to FDA Panel (MedPage Today) (Gray Sheet-$)
  • FDA to Hold Meeting on New Methods for Thrombogenicity Testing (FDA)
  • AngioDynamics gains expanded FDA clearance for its bypass device at a crucial time (Fierce) (Mass Device)
  • Wright Medical can submit more data to FDA for Augment bone graft (Mass Device)
  • Whole Genome Scans Aren't Quite Ready For Your Doctor's Office (NPR) (AP) (TIE)
  • Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers (FDA)
  • M&A Slowdown and Drop in FDA Approvals Stifles Growth of Medtech Sector in 2013 (Press)

US: Dietary Supplements

  • Class-Actions Increasing As Fallout From Regulatory Action (Tan Sheet-$)

US: Assorted And Government

  • Regulatory czar wants to speed up review process (The Hill)
  • GAO Report: Regulatory Review Processes Could Be Enhanced (GAO)
  • Vaccinations next religious target if 'Hobby Lobby' prevails, legal experts warn (SCRIP-$)
  • Controversial pediatric research bill goes to Obama (BioCentury)
  • Republicans pull Medicare Part D bill (The Hill)

Europe

  • IMI pushes stakeholders to GETREAL in new €16m 'real clinical data' project (SCRIP-$) (BioCentury)
  • SMC recommends six products but rejects two for diabetes (SCRIP-$)
  • No price ceiling for rare disease drugs, say UK MPs in Survey (PMLive) (Pharma Letter-$) (Pharmafile)
  • French plan to allow use of Avastin in AMD on cost grounds (SCRIP-$)
  • Bird-killing vet drug alarms European conservationists (Guardian)
  • RTI Surgical Receives CE Mark Approval for Fortiva Porcine Dermis (Press)
  • Sterilucent Receives CE Mark for Hydrogen Peroxide Sterilizer in Europe (Press)

India

  • CDSCO analysis reveals prevalence of substandard drugs in India (In-Pharma)
  • Cipla may put patent for new HIV drug in open access pool (Livemint)

Japan & China

  • NeuroMetrix Submits Regulatory Application for NC-stat DPNCheck in Japan (Press)

Other International

  • Report from the most recent ICH Meeting (ICH)
  • Advocates Pan TPP Data Exclusivity Proposal (IPS)

General Regulatory And Interesting Articles

  • Determining Criticality-Process Parameters and Quality Attributes Part III: Process Control Strategies-Criticality throughout the Lifecycle (BioPharm International)

Regulatory Reconnaissance #274 - 12 March 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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