Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 June 2013)

Regulatory Reconnaissance (24 June 2013)

Posted 24 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Will A Powerful New Ministry Lead To A Favorable Regulatory Environment In China? (PharmAsia)
  • Sources Say Ranbaxy Plant Receives FDA Form 483 After Inspection of Mohali Plant (Reuters) (BioSpectrum)
  • Astellas wins EU approval for prostate cancer drug Xtandi (PMLive) (Astellas) (Pharma Times)
  • Teva Launches Generic Version of Viagra (sildenafil) in Countries Across Europe (Teva)
  • Indian Health ministry to introduce medical electronics & devices bill in Parliament soon (PharmaBiz)
  • EU member states show some of their cards on medical devices revision (MedicalDevicesLegal)
  • Could medtech industry find support from European Council? (Clinica)
  • Interview With David Haslam, NICE's New Chairman (Pharmafile)
  • EMA under attack again over document disclosure (SCRIP)

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

US

Pharmaceuticals/Biotechnology
  • Woodcock Explains What Breakthrough Product Designation Means for Companies and FDA (BioCentury)
  • The FDA's Cancer Czar Says He Can't Approve New Drugs Fast Enough (Forbes)
  • FDA approves Theravance's antibiotic lung drug Vibativ for wider use (FDA) (Reuters) (BioCentury) (MNT) (PMLive) (SCRIP)
  • Takeda Files Selective Intregrin Antagonist Vedolizumab For IBD (Pink Sheet) (DD&D) (Fierce) (BioCentury) (SCRIP) (Takeda)
  • Novartis tests biosimilar copy of Amgen's Enbrel in late-stage trial (Reuters) (Pharma Letter)
  • FDA puts Cell Therapeutics blood cancer drug on hold after death (Reuters)
  • Novartis' serelaxin receives breakthrough designation (BioCentury) (EP Vantage) (SCRIP) (Reuters) (Fierce) (Pharma Times)
  • FDA Informed Consent Guidance Under Development; HIV Studies Present Unique Challenges (Pink Sheet)
  • Generic User Fees Need Small Business Waiver, Firms Say; Congress May Agree (Pink Sheet)
  • FDA Panel To Weigh Unmet Need Vs. Liver Injury With Samsca Kidney Indication (Pink Sheet)
  • Maine Votes In Favor Importing Drugs From Foreign Pharmacies (Pharmalot)
  • FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System (IPQ)
  • FDA Posts New Plan B OTC Label (FDA)
  • FDA Approves ANDAs for Fresenius Kabi's Levofloxacin (#200674), Dr. Reddy's Lamotrigine (#202383) (FDA)
  • FDA grants label update for BMS Sprycel (SCRIP)
  • Novo Nordisk's R&D chief sizes up diabetes rivals and scandal-wary FDA (Fierce)
  • Fast, Cheap And Within Control: FDA's Progress Toward Better Flu Vaccines (Pink Sheet)
  • Pay-For-Delay Deals May Be Smaller After Supreme Court Okays FTC Suits (Pink Sheet)
  • The Real Story Behind FDA's Delayed Approval Of Eliquis (In Vivo Blog) (Forbes)
  • Pfizer Announces FDA Acceptance for Review of Application to Expand Labeling for XELJANZ for Rheumatoid Arthritis (Pfizer)
  • 'Black Box Warning' Counters Levaquin Claims, Judge Says (Law 360)
  • State AGs ask Arkansas high court to back J&J's $1.2B Risperdal fine (Fierce)
  • The California ePedigree Timeline Vs. The Senate Bill Timeline (RxTrace)
  • Overuse of common painkiller may increase health risk (CBS)
  • Meeting of the National Vaccine Advisory Committee (FDA)
American Diabetes Association (ADA) Meeting Wrapup
  • Sanofi's next-generation insulin shows edge over Lantus (Reuters) (Fierce) (Pharma Times)
  • Lilly once-weekly diabetes drug proves superior in late-stage trials (Reuters) (WSJ) (Fierce) (SCRIP)
  • Boehringer, Lilly tout PhIII results for another SGLT2 drug (Fierce)
  • Takeda's Alogliptin shows long-term efficacy in comparative trial (SCRIP)
  • Boehringer Presents Huge Amount of Data on Empaglifozin, Linagliptin (BI) (BI) (BI) (BI) (BI)
  • Zafgen's obesity drug drives dramatic weight loss in PhII test (Fierce) (Xconomy)
  • GlaxoSmithKline reveals mixed results for diabetes contender in 'crowded area' (Fierce) (GSK)
  • AstraZeneca and BMS Present Data on Dapaglifozin (AZ/BMS)
Pharmaceuticals: General
  • Drug Companies Pay More for Research Than for Promotional Speeches (CuttingEdge)
  • CDC Clears Protein Sciences' Flublok for Adult Use (CBS) (MedPage Today)
Medical Devices
  • mHealth group urges FDA to publish final medical apps guidance (mHIMSS) (Gov Health IT) (VentureBeat) (MedCity News)
  • FDA Investigators: Manufacturers Often Play 'Games' During Facility Inspections (Gray Sheet)
  • Medtronic takes 'first step' toward U.S. sale of artificial pancreas (Reuters) (AP) (WSJ)
  • J&J's Animas reveals positive artificial pancreas data (Fierce) (Clinica)
  • Industry picks holes in US proposal on using symbols on device labels (SCRIP)
  • Patent Troll Lawsuits Rare In Device Industry, But May Increase, Attorneys Say (Gray Sheet)
  • FDA Clears Lombard's Next Generation Aorfix Delivery System (MedGadget)
  • Quidel Says FDA Approves Streptococcus A Test (PharmPro)
Assorted and Government
  • FDA Seeks Seizure of DMAA Products at GNC Warehouse (Natural Products Insider) (NYTimes) (NI-USA)
  • Senate committee passes FDA FY14 funding bill  (Strengthen FDA) (BioCentury) (Gray Sheet)
  • Beta Labs, LTD Announces a Recall of Dietary Supplements Oxyphen, Phentalene, Phen FX, and Red Vipers Due to Possible Health Risk (FDA)
  • GPhA Calls on new US Trade Representative to be More Transparent in Negotiation of Trans-Pacific Partnership (GPhA)
  • Proposed Changes In Organ Donation Stir Debate (NPR)
  • US Capitol Capsule: Obama takes aim at trade secret thieves, counterfeiters (SCRIP)
  • FDA Announces Grant Funding Available for Veterinary Testing Methods (FDA)
Upcoming Meetings and Events
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting of the National Biodefense Science Board (DHHS)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 26 June 2013: General and Plastic Surgery Devices Panel of the Medical Devices Meeting (FDA)
  • 27 July 2013: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 27 June 2013: Mobile Medical App Entrepreneurs: Changing the Face of Health Care (House)
  • 27 June 2013: A Tangle of Trade Barriers: How India's Industrial Policy is Hurting U.S. Companies (House)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Investigation wraps up, Teva cleared in switched drug packaging affair (MedCity News)
  • Astellas wins EU approval for prostate cancer drug Xtandi (PMLive) (Astellas) (Pharma Times)
  • EU member states show some of their cards on medical devices revision (MedicalDevicesLegal)
  • Could medtech industry find support from European Council? (Clinica)
  • Interview With David Haslam, NICE's New Chairman (Pharmafile)
  • EMA under attack again over document disclosure (SCRIP)
  • EU Tense as Crunch-Time for Counterfeits Approaches (PharmExec)
  • Teva Launches Generic Version of Viagra (sildenafil) in Countries Across Europe (Teva)
  • Generic firms poised as Viagra goes off-patent in Europe (Pharma Times) (Pharmafile)
  • Like chalk and cheese: the agencies that make up the European drug regulatory network and their leaders (SCRIP RA)
  • Boehringer Ingelheim Submits Application to EMA for use of Pradaxa in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE (BI)
  • UK industry condemns specials "drug pricing racket" (SCRIP)

Asia

  • Will A Powerful New Ministry Lead To A Favorable Regulatory Environment In China? (PharmAsia)
  • Sources Say Ranbaxy Plant Receives FDA Form 483 After Inspection of Mohali Plant (Reuters) (BioSpectrum)
  • Indian Health ministry to introduce medical electronics & devices bill in Parliament soon (PharmaBiz)
  • India: "Unfair and Discriminatory"? (Drug Wonks)
  • Sri Lanka Minister Says Drug Makers, Suppliers Slow To Deliver Vital Drugs (PharmAsia)

Other International

  • Canada: Guidance Document: Determining Prescription Status for Human and Veterinary Drugs (Health Canada)
  • Consultation: Australian regulatory guidelines for complementary medicines (ARGCM) Part D: Registered complementary medicines (TGA)
  • New Zealand's PHARMAC Agrees to Fund Blood Thinner Drug Brilinta (ticagrelor) (PHARMAC)

General Regulatory and Interesting Articles

  • Online Adverse Event Monitoring Could Guide Ph IV Spending say Researchers (Outsourcing Pharma)

Regulatory Reconnaissance #94 - 24 June 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe