Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Three Drugs, Considers Safety of GM Mosquitos (26 January 2015)

Regulatory Recon: FDA Approves Three Drugs, Considers Safety of GM Mosquitos (26 January 2015)

Posted 26 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approves Three Drugs, Considers Safety of GM Mosquitos (26 January 2015)

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

In Focus: US

In Focus: International

  • German regulator hails European Medicine Agency's drugs suspension on GVK Bio data (India Times)
  • EMA posts guide to help IT teams with its new pharmacovigilance database (Fierce)
  • France Poised to Overhaul Quality Control Measures for Medical Devices (ANSM)
  • Brave new world: how to navigate the new Japanese medical device regulatory landscape (Clinica-$)
  • Ottawa to miss deadline for thalidomide victims’ financial aid (Globe and Mail)
  • Davos: Scientists call for changes to streamline regulation of cancer drugs (Financial Times-$)

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US: Pharmaceuticals and Biotechnology

  • FDA approves Novartis' meningitis B vaccine (BioCentury) (SCRIP-$) (MedPage Today) (Press) (FDA)
  • FDA approves NPS's Natpara with boxed warning (BioCentury) (PharmaTimes) (Reuters) (Press) (FDA) (SCRIP-$)
  • FDA debates releasing genetically modified mosquitoes into Florida Keys to fight viruses (AP)
  • FDA approves Rockwell Medical's iron replacement drug (Reuters) (Fierce)
  • Astellas Antifungal Isavuconazole In Line For 12-Year Exclusivity: QIDP+Orphan Combos Are Rare (RPM Report-$)
  • Former FDA Commissioner David Kessler might testify against J&J in Philly case (Philly Pharma)
  • Report Card: FDA Earns a Solid “B” on Timely Responding to Section 505(w) Discontinuation Citizen Petitions (FDA Law Blog)
  • FDA to Soon Review Chin Fat Drug Made by Kythera Biopharmaceuticals (Tarius) (Bloomberg)
  • Second Turkish man sentenced in fake Avastin case (Securing Industry) (FDA)
  • Generic Drug Cos. Face Failure-To-Warn Claims In Calif. (Law 360-$)
  • CRL for Antares Pharma's Sumatriptan Injection ANDA (Press)
  • Industry Groups Need FDA Input On Antibacterial Ingredient Studies (Tan Sheet-$)
  • Impax Receives FDA Approval for a Generic Version of Lamictal (Press)
  • Symplmed Announces FDA Approval of Prestalia for Treatment of Hypertension (Press)
  • Economists, Docs Back Actavis In Namenda Injunction Row (Law 360-$)
  • FDA process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology (PubMed)
  • Seniors, Unions Want Provisions To Help Lower Rx Prices Added To 'Cures' Bill (IHP-$)
  • DSCSA Exception Handling: A Preview of Your Next Surprise Headache (RxTrace)
  • REMS Patent Safe For Now, But Pharma Still Facing PTO ‘Death Squads’ (Pink Sheet-$)
  • GPhA’s Next CEO Will Face Political, Regulatory Headwinds (Pink Sheet-$)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL Due to Particulate Matter (FDA)
  • J&J's Risperdal Caused Boy's Breast Growth, Philly Jury Told (Law 360-$)
  • Nexium Ruling Offers Road Map For Pay-For-Delay Classes (Law 360-$)
  • New Thoughts on the "Forgotten" Aspect of Antimicrobial Stewardship: Adverse Event Reporting (PubMed)
  • Cox Veterinary Laboratory, Inc. Issues Voluntary Recall of “Gastroade Xtra” (FDA)
  • Experts see value in stronger oversight of compounded drugs in hospitals (Modern Healthcare-$)

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

  • Regeneron/Sanofi cholesterol drug gets FDA priority review thanks to voucher (Reuters) (Fierce) (Press) (SCRIP-$) (Bloomberg)
  • USA fast-tracks Shire Hunter syndrome drug  (PharmaTimes) (Press)
  • FDA Grants Fast Track Designation for BioCryst's BCX4161 for the Treatment of Hereditary Angioedema (Press)
  • Ipsen announces topline results of two double-blind phase III studies of Dysport® in lower limb spasticity in children and in adults (Press)
  • Aprea's Ovarian Cancer Drug Gains Orphan Drug Designation (Press)

US: Pharmaceuticals and Biotechnology: General

  • Court to rule on lethal-injection protocol (SCOTUSblog) (NYTimes)
  • Safety concerns cloud early promise of powerful new cancer drugs (Reuters)
  • Pediatricians Urge DEA to Reclassify Medical Marijuana to Boost Research (Pharmalot)
  • New Painkiller Drug, Hyslinga, launches (Press)
  • Viewpoint: State of the pharma supply chain (Securing Industry)
  • U.S. pediatricians reaffirm opposition to legalized pot (Reuters) (AP)

US: Medical Devices

  • FDA’s Move on LDTs: A Power Grab? (MDDI)
  • FDA clears new medical app to track real-time glucose levels in diabetics (Washington Post) (MedCityNews) (FDA)
  • Roche receives FDA clearance for next generation cobas MRSA/SA Test (Press)
  • Medtronic Enterra II System for Intractable Nausea and Vomiting Lands FDA HDE Approval (MedGadget) (Fierce) (Mass Device)
  • Med-El wins FDA approval for Synchrony MRI-safe cochlear implant (Mass Device)
  • Integra Resolves Warning Letter On Puerto Rico Facility (Gray Sheet-$)
  • Nevro approaches US with first novel spinal cord device in a decade (EPvantage) (Fierce)
  • Plaintiffs’ lawyers reject J&J claims of fraud in mesh lawsuits (Reuters)
  • Virginia Mason says steps taken to correct endoscope safety issues (Modern Healthcare-$)
  • 9th Circ. Flips Kimberly-Clark Unit's Pain Pump Win (Law 360-$)
  • Heart muscle regeneration induced by long-term use of ventricular assist devices (MNT) (MedDeviceOnline)

US: Dietary Supplements

  • Protecting DSHEA, Pumping Up Profile Lead Dietary Supplement Industry Priorities For 2015 (Tan Sheet-$)

US: Assorted And Government

  • FDA to Play Key Role in Obama's Request for Funding to Boost Personalized Medicine (NYTimes)
  • US, India to Create "High Level Working Group on Intellectual Property" (White House)
  • Trans-Pacific Partnership push waits on cue from Obama's India visit (Fierce)
  • Senate GOP building momentum for regulatory reform (The Hill)
  • FDA Enforcement Report (FDA)

Upcoming Meetings

Ebola Outbreak

  • Liberia Ebola vaccine trial 'challenging' as cases tumble (Reuters)
  • Ebola experts say 16 other bat viruses could infect man (Reuters)

Europe

  • German regulator hails European Medicine Agency's drugs suspension on GVK Bio data (India Times)
  • EMA posts guide to help IT teams with its new pharmacovigilance database (Fierce)
  • France Poised to Overhaul Quality Control Measures for Medical Devices (ANSM)
  • Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate) (Press)
  • Gilead cuts hepatitis C drug prices in Germany (PMLive)
  • Enlivex Granted EU Orphan Drug Designation for Lead Product ApoCell for Graft-Versus-Host Disease (Press)

India

  • Insight On India – Highlights From The Week Of Jan 18-24, 2015 (Two-Four Insight)
  • New drug added to generic Sovaldi licensing (Pharmafile)

Japan

  • Brave new world: how to navigate the new Japanese medical device regulatory landscape (Clinica-$)
  • ALK's partner Torii submits NDA in Japan for house dust mite sublingual tablet (PharmaLetter-$)

Canada

  • Ottawa to miss deadline for thalidomide victims’ financial aid (Globe and Mail)
  • Trimel Announces Filing of NATESTO With Health Canada (Press)

Other International

  • Davos: Scientists call for changes to streamline regulation of cancer drugs (Financial Times-$)

General Regulatory And Interesting Articles

  • A New Index Measures Impact Pharma Has on Infectious Diseases (Pharmalot)
  • Scientists speed tests of brain tumor drugs (AP)
  • Scientists unboil an egg, and it may be a big deal for drug research (CNBC)
  • Taking Antibiotics During Travel Fosters Drug-Resistant Germs (NPR)
  • Scientists want to find new drugs in your local dirt, so send some in (Washington Post)
  • Meant to Keep Malaria Out, Mosquito Nets Are Used to Haul Fish In (NYTimes)

Regulatory Reconnaissance #479 – 26 January 2015

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.

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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