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Regulatory Reconnaissance (22 April 2013)

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By Alexander Gaffney, RF News Editor

Good morning and welcome to another edition—our 50th!—of Regulatory Reconnaissance.

In Focus: US
  • Mystery objectors delay weight loss drug (Financial Times)
  • An Open Letter To The PhRMA CEO On Pharma's Image (Forbes)
  • ODAC Veterans Disagree On Value Of Public Hearing At Panel Meetings (The Pink Sheet) ($)
  • Regulatory Freelancing: Rare Disease Group Hopes To Shape FDA Guidance (The Pink Sheet) ($)
  • CDRH’s Shuren: Expect Action Soon on Early Feasibility, IDE Guidances (FDA News) ($)
  • FDA Rule on Symbols in Labeling Could Save Devicemakers Millions (FDA News) ($)
  • US Patent Office Awards Four Entities—Gilead, BD, Sproxil and UC Berkeley—With "Patents for Humanity" Awards (USPTO)
In Focus: International
  • Drug test rules ‘would eliminate biotechnology sector in UK’, Roche Employee Says (Financial Times)
  • European drug applications 'stable but more complex in 2012' (PMLive)
  • UK likely to pay for Avastin despite another NICE rejection (Fierce Pharma)
  • India's clinical trial industry shrivels in wake of safety controversy (Fierce Biotech)
  • ENVI Draft Report on Use of Genetic Information (ENVI)
  • TTIP Negotiations to Start By Summer; Device Groups Push for Single Audit (FDA News) ($)
  • USP, India's National Institute of Biologicals to jointly work to improve regulatory standards in India (PharmaBiz)
  • European Commission gives green light to new 6-in-1 childhood vaccine from Sanofi, MSD (PMLive) (Reuters)
  • EU pharma CEOs earned 85% less than U.S. peers (Fierce Pharma)

US

Pharmaceuticals/Biotechnology
  • Mystery objectors delay weight loss drug (Financial Times)
  • Pharma giants' oral EPO alternatives could cater to dopers (Reuters) (Fierce Biotech)
  • Grand Jury To Probe Compounder Over Meningitis Outbreak (Law 360) ($)
  • Sanofi Can't Duck Amphastar's FCA Suit Over Lovenox (Law 360) ($)
  • An Open Letter To The PhRMA CEO On Pharma's Image (Forbes)
  • FDA OxyContin decision: anti-abuse or anti-competition? (Thomson Reuters)
  • Ingredient Maker Escapes Liability In Drug Recall Suit (Law 360) ($)
  • FDA grants tentative approval to two Sun generics (DSN)
  • FDA Grants Tentative Approval for Par Pharmaceuticals' Generic Valsartan (Amlodipine) (FDA)
  • ODAC Veterans Disagree On Value Of Public Hearing At Panel Meetings (The Pink Sheet) ($)
  • US FDA approves Alcon's Simbrinza, a fixed-combination therapy for glaucoma (The Pharma Letter) ($) (BioSpectrum) (Pharma Times)
  • Regulatory Freelancing: Rare Disease Group Hopes To Shape FDA Guidance (The Pink Sheet) ($)
  • Generic OxyContin Criteria Being Developed By FDA Working Group (The Pink Sheet) ($)
  • OxyContin’s Abuse-Deterrent Claims Strong, But Stronger Claims Possible (The Pink Sheet) ($)
  • GPhA Welcomes Bipartisan Policy Center Proposal to Save Billions Through Increased Use of Generics (GPhA) (FDA News) ($)
  • Is It Time for Off-the-Shelf Birth-Control Pills in the US? (NYTimes)
  • FDA Approves Nine Changes for Fresenius Medical's Deflex with Dextrose (FDA) (NDA #018883)
  • FDA Approves Labeling Revision for Bayer's Aleve (FDA)
  • Oklahoma Clinic Owners Sentenced In Misbranded Drugs Case (Safe Medicines)
  • Report: Don't count Celltrion out of Rituxan biosim race (Fierce Biotech) (Biosimilar News)
  • Public Citizen: Compounding pharmacies can be regulated by FDA (Washington Post)
  • Opinion: Congress, FDA should look to existing technology to make pharmacy compounding safer (Alabama Live)
  • Tucson company launching late-stage clinical trial for its cancer-prevention drug (Med City News)
  • US and French Customs Officials Seize Controlled Substance (CBP)
  • FDA Looking to Buy a Portable Mass Spectrometer (FDA)
  • New Drug Shortage: Hospira's Verapamil Hydrochloride Injection, USP (FDA)
  • FDA Releases Updated Medication Guides for Ten Medications (FDA)
  • FDA Should Reject Breo, Public Citizen Tells Advisory Committee (Public Citizen)
Medical Devices
  • CDRH’s Shuren: Expect Action Soon on Early Feasibility, IDE Guidances (FDA News) ($)
  • CDRH Sequestration Impact: Training, Standards And Reg Science (The Gray Sheet) ($)
  • FDA Rule on Symbols in Labeling Could Save Devicemakers Millions (FDA News) ($)
  • Recall: Covidien pulls ventilator batteries amid defect concerns (Mass Device) (Fierce Medical Devices)
  • HHS workgroup could shape mHealth regulation (MobiHealth News)
  • FDA Mulls Impact of Nature's Wrath on Device Supply (Med Page Today)
  • Jury Awards Eleven Year Old Girl $7.2 Million After Receiving Defective Medical Device (PRWeb)
Assorted
  • US Patent Office Awards Four Entities—Gilead, BD, Sproxil and UC Berkeley—With "Patents for Humanity" Awards (USPTO)
  • BioCentury Explores the Myriad Case (BioCenturyTV)
  • FDA Posts Transcript for ALS Disease Meeting (With Tracked Changes—Oops) (FDA)
  • GNC Hit With False Ad Claims Over Triflex Joint Product (Law 360) ($)
  • Paper: OHRP and Public Citizen Are Wrong about Neonatal Research on Oxygen Therapy (Bioethics Forum)
  • NAD advises USPLabs to tone down advertising claims supporting AP supplement (DSN)
  • AARP: Medicare Drug Savings Act of 2013 has senior rebates (UPI)
  • Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications (FDA)
  • Physician Payment Sunshine: Some Pharmaceutical Companies Reduced Meal Payments to Health Care Providers (Policy and Medicine)
  • As FDA Seeks Fees to Fund Food Safety, Much of Industry Remains Opposed to Idea (Food Safety News)
Government and Budget
  • US Capitol Capsule: 'Tough' week underscores US vulnerability, MCM funding need (SCRIP Intelligence)
  • Compounding: How Does FDA Expand Oversight Without Legislation? (The Pink Sheet) ($)
Upcoming Meetings and Events
  • 22 April 2013: Public Meeting - International Consortium of Cardiovascular Registries (FDA)
  • 23 April 2013: FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (FDA)
  • 23 April 2013: Margaret Hamburg to Keynote FDLI's Conference (FDLI)
  • 23 April 2013: FDA Listening Meeting on Use of Antibiotics in Animals in Olympia, WA (FDA)
  • 25 April 2013: Securing Our Nation's Prescription Drug Supply Chain (Energy and Commerce Committee)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 25-26 April 2013: Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • 26 April 2013: Does HIPAA Help or Hinder Patient Care and Public Safety? (Energy and Commerce Committee)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)

International

  • Drug test rules ‘would eliminate biotechnology sector in UK’, Roche Employee Says (Financial Times)
  • European drug applications 'stable but more complex in 2012' (PMLive)
  • UK likely to pay for Avastin despite another NICE rejection (Fierce Pharma)
  • India's clinical trial industry shrivels in wake of safety controversy (Fierce Biotech)
  • Clinical trials of drugs in India plummet (New Indian Express)
  • ENVI Draft Report on Use of Genetic Information (ENVI)
  • TTIP Negotiations to Start By Summer; Device Groups Push for Single Audit (FDA News) ($)
  • USP, India's National Institute of Biologicals to jointly work to improve regulatory standards in India (PharmaBiz)
  • Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials (Cochrane Collaboration)
  • In Australia, Gene Patents Also Subject of High Court Struggle (Science Insider)
  • EMA Assessment Report of Teicoplanin as Requested by France's ANSM (EMA)
  • Team NB FAQ on EN62304 standard for software lifecycle processes (Medical Devices Legal)
  • Ventripoint’s expanded CE Mark extends heart imaging platform to “nearly every patient” (Mass Device)
  • Australia Seeks To Join Apotex In Suit Against Sanofi For Delaying Generic (PharmAsia News) ($) (BioSpectrum)
  • Rajasthan govt to give free cancer drugs (India Times)
  • European Union Drugs Strategy 2013-2020 (EU)
  • German Policies Hamper Innovation (FDA News) ($)
  • Ireland launches first "preferred drugs" list (Pharma Times)
  • New Drug Price Control Order in India Ready, But Awaiting Supreme Court Ruling (PharmaBiz)
  • Xarelto gains NICE thumbs up for DVT licence (Pharma Times)
  • European Commission gives green light to new 6-in-1 childhood vaccine from Sanofi, MSD (PMLive) (Reuters)
  • Lundbeck launches alcohol drug Selincro in Europe (PMLive)
  • Century Medical gets Japanese nod for Glider catheter (BioSpectrum)
  • Intas launches rituximab biosimilar, Mabtas in India (Biosimilar News)
  • GSK and Theravance announce regulatory submission for Anoro Ellipta (UMEC/VI) in Japan (GSK)
  • Report on the annual accountsof the European Medicines Agency for the financial year 2011 (EMA)

General Regulatory and Interesting Articles

  • EU pharma CEOs earned 85% less than U.S. peers (Fierce Pharma)
  • Samsung demos a tablet controlled by your brain (Med City News)
  • Hilary Koprowski, Who Developed First Live-Virus Polio Vaccine, Dies at 96 (NYTimes)
  • Multifunctional Drugs May Offer Better-Than-Additive Effects (MIT Technology Review)
  • Large study finds no vaccine link to nerve disorder (NBC)
  • Study Finds Zoledronic Acid Inhibits Formation of New Bone (Adverse Events)
  • Study Finds Abortion Rates Higher in Women Exposed to TNF Inhibitors Compared to Methotrexate (Adverse Events)
  • Revolutionary Autoinjector Pushes The Limits Of High Viscosity Drug Delivery (Medical News Today)
  • Controlling Some Devices Will Be A Snap (Scientific American)
  • I’m a patient: show me the trial data (BMJ)
  • Cyclists, body builders happy to be lab rats for failed pharma experiments (Med City News)

Regulatory Reconnaissance #50 – 22 April 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 editor@raps.org.




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