Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 May 2013)

Regulatory Reconnaissance (20 May 2013)

Posted 20 May 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • NYTimes Reports Chinese Hackers Going After, Among Other Things, Clinical Trials Results (NYTimes)
  • FDA Plan B case raises questions about generic copycats (Thomson Reuters)
  • California Senate requires larger print for drug labels (LATimes)
  • Should Patient Organizations Partner With Industry? The Case of Vertex's Kalydeco (Journal Sentinel) (Forbes)
  • Trolls Amassing "War Chests" Of Device Patents, Industry Exec Warns House Panel (The Gray Sheet)
  • Sanofi plans regulatory filings for myelofibrosis drug treatment after successful drug trial (Reuters) (BioCentury) (The Pharma Letter) (Sanofi) (Fierce Biotech)

In Focus: International

  • Australian Judge refuses to approve Vioxx settlement (SMH)
  • Pregnant Canadian women sue over faulty birth control pills (Raw Story)
  • UK calls for international action on antimicrobial resistance (DOH)
  • Sanofi May Get EU Double Whammy After French Fine For Hindering Entry Of Plavix Generics (The Pink Sheet)
  • India Health Ministry Said To Do Little To Deal With Foreign-Banned Drugs (PharmAsia News)
  • India's new drug policy: Good for Consumers, Bad for Industry? (India Times) (India Times) (India Times)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Plan B case raises questions about generic copycats (Thomson Reuters)
  • California Senate requires larger print for drug labels (LATimes)
  • Consumer Group Flags High SPF Ratings on Sunscreen (AP)
  • Sanofi plans regulatory filings for myelofibrosis drug treatment after successful drug trial (Reuters) (BioCentury) (The Pharma Letter) (Sanofi) (Fierce Biotech)
  • Anthrax drug brings $334 million to Pentagon advisor's biotech firm (LATimes)
  • Do Patient Organizations Raise Conflicts of Interest When They Partner With Large Pharmaceutical Companies? The Case of Vertex's Kalydeco (Journal Sentinel) (Forbes)
  • Key stakeholder Teva tries to stay out of limelight in drug controversy (Med City News)
  • It Takes Two: FDA Reorganizes Office Of Information Management (The Pink Sheet)
  • Lawmakers Considering User Fees For Animal Pharmaceutical Industry (CQ Roll Call)
  • Synageva's Sebelipase Alfa Receives Breakthrough Therapy Designation for Early Onset LAL Deficiency from the U.S. Food and Drug Administration (Business Wire)
  • FDA's Benefit-Risk Templates for Drug Reviews Lack Patient Input Process: NORD (FDA News)
  • The Risperdal Lawsuits Keep On Coming: Kentucky Sues J&J (Pharmalot)
  • Flushing Sound: PhRMA Threatens Another County Over Take-Back Plan (Pharmalot)
  • Ranbaxy Fraud Settlement Emphasizes Guilty Pleas, Downplays Exclusion (The Pink Sheet)
  • Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (FDA) (FDA)
  • Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S. (PR Newswire) (Medical Daily)
  • FDA, USP Enlist Industry's Help in Improving OTC Drug Quality (FDA News)
  • Impax Laboratories Launches Authorized Generic of Zomig (zolmitriptan) Tablets and Orally Disintegrating Tablets in the U.S. (Business Wire)
  • Man Pleads Guilty in Two Federal Cases Involving Importation of Ephedrine into the United States and Actions to Introduce Misbranded Drug into Commerce (FDA)
  • Compounding: Can FDA Afford The New Oversight It Wants? (The Pink Sheet)
  • Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for US Drug Safety (Public Citizen)
  • Mylan launches cholesterol drug (DSN) (The Pharma Letter)
  • Lundbeck says drug shows improvement in depression symptoms during PhIII trial (Reuters) (Pharma Times) (Bloomberg)
  • Novo Nordisk says completes hemophilia drug trial (Reuters) (BioCentury) (Fierce Biotech)
  • XenoPort Reports Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil for Spasticity in Multiple Sclerosis Patients (Business Wire) (Reuters)
  • Alnylam to file rare disease drug application in 2014 (Boston Biz Journal)
  • New PREA Documents Posted for Paragon BioTeck's Phenyephrine hydrochloride solution (FDA)
  • FDA Posts New and Updated Medication Guides (FDA)
  • FDA Approves ANDAs for: Accord Healthcare's Tramadol HCl (202390), Jiangsu Hengrui Med's Letrozole (202716), Apotex's Rivastigmine Tartrate (091072), Zydus Pharmaceuticals' Zolmitriptan (202890) (FDA)
Medical Devices
  • Trolls Amassing "War Chests" Of Device Patents, Industry Exec Warns House Panel (The Gray Sheet)
  • New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence (The Gray Sheet)
  • FDA Posts Meeting Materials for Orthopaedic and Rehabilitation Devices Panel (FDA)
  • Medtronic v. Boston Scientific SCOTUS Case Expected to see Closure This Week (SCOTUS Blog)
  • 99 Cent Urinalysis App Raises Questions About mHealth Standards (The Gray Sheet)
  • Analyst: New Hospira Warning Raises Questions on Quality Culture (FDA News)
  • Thoratec Announces FDA Approval Of HeartMate II Pocket Controller (PR Newsire) (Fierce Medical Devices) (Mass Device) (MedGadget)
  • J&J Initiates Class 2 Recall for around 40,000 Acuvue Moist Contact Lenses (FDA) (FDA)
Assorted and Government
  • House releases its 302(b) allocations for FY 14 appropriations (Alliance for a Stronger FDA) (More)
  • Sunshine Act Payment Comparisons Likely Cloudy Due To Disclosure Judgment Calls (The Pink Sheet)
  • Life Science Court Report (Patent Docs)
  • Actavis to buy Warner Chilcott in $8.5 billion deal (Reuters)
  • US Capitol Capsule: IRS scandal new snag for Obamacare (SCRIP Intelligence)
  • Informational Meeting Concerning Compliance With the Centers for Disease Control and Prevention's Import Permit Program; Public Webcast (CDC)
  • 'Chemicals of Concern' list still wrapped in OMB red tape (CPI)
  • The Adoption and Impact of Adaptive Trial Designs (Tufts)
  • Former FDA official on GMO labeling: 'Science doesn't always win' (Food Navigator USA)
  • Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: In Vitro Diagnostics for Prediction of Therapeutic Efficacy in Cancer and Other Angiogenesis-Mediated Diseases (NIH)
Upcoming Meetings and Events
  • 21 May 2013: First-Ever Patient Network Town Hall (FDA)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 22 May 2013: Congressional Hearing: "Food and Drug Safety, Public Health, and the Environment in China" (CECC)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Australian Judge refuses to approve Vioxx settlement (SMH)
  • Pregnant Canadian women sue over faulty birth control pills (Raw Story)
  • UK calls for international action on antimicrobial resistance (DOH)
  • Sanofi May Get EU Double Whammy After French Fine For Hindering Entry Of Plavix Generics (The Pink Sheet)
  • European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level (EMA)
  • India Health Ministry Said To Do Little To Deal With Foreign-Banned Drugs (PharmAsia News)
  • India's new drug policy: Good for Consumers, Bad for Industry? (India Times) (India Times) (India Times)
  • European pharmacist organizations make joint call for action on medicines shortages (The Pharma Letter)
  • Pharma access problems "putting EU at risk" (Pharma Times)
  • Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter (Boardvote)
  • Bayer submits Japanese application for riociguat (BioCentury)
  • TaiGen submits nemonoxacin applications in Taiwan, China (BioCentury)
  • G-BA rebuffs Pixuvri, Trajenta for second indication (BioCentury)

General Regulatory and Interesting Articles

  • 'Love Hormone' Promises Safer Births After Pfizer Flop (Bloomberg)
  • Thalidomide - The Real Story & The First Seal Baby (Health World Net)
  • Can Patents Keep Up With Technology? (Scientific American)
  • Newer whooping cough vaccine not as protective (Reuters)
  • Big companies and small ones are building devices that are easier to hack, modifiy repair (Med City News)
  • Sensors For Heart Devices, Consumer Electronics, Vulnerable To Certain Security Risks (MNT)
  • Rethinking the Pharma Supply Chain: New Models for a New Era (Boston Consulting Group)
  • Bill Gates: 'Death is something we really understand extremely well' (Washington Post)
  • A Dilemma in the Search for Breast Cancer (WSJ)
  • Commonly used catheters double risk of blood clots in ICU and cancer patients (EurekAlert)
  • Researchers Face Off Over Incretin Risk (MedPage Today)

Regulatory Reconnaissance #70 - 20 May 2013

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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