Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Drugmakers Team up With NIH to Open and Accelerate Research (4 February

Regulatory Reconnaissance: Drugmakers Team up With NIH to Open and Accelerate Research (4 February 2014)

Posted 04 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Ten Drug Companies Form Pact With NIH to Find Paths to New Medicines (WSJ-$) (SCRIP-$) (Bloomberg)
  • OPDP Offers Insight into Enforcement Strategy and Warning Letters (Policy and Medicine)
  • DOJ's Stuart Delery: The Business Case For Compliance (RPM Report-$)
  • U.S. FDA rejects RedHill's and IntelGenx's migraine drug (Reuters)
  • FDA approves pediatric use of Dexcom's G4 Platinum continuous glucose monitoring system (FDA) (Press)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • OPDP Offers Insight into Enforcement Strategy and Warning Letters (Policy and Medicine)
  • DOJ's Stuart Delery: The Business Case For Compliance (RPM Report-$)
  • U.S. FDA rejects RedHill's and IntelGenx's migraine drug (Reuters)
  • BIO Responds to GPhA Citizen Petition on Biosimilars Naming (BIO)
  • NYT Slams "Low-T" Treatments (NYTimes)
  • 4 reasons why J&J's agreement to share clinical trial data with Yale will help drug industry (MedCity News)

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

  • Are Press Releases of Phase III Data too Optimistic? (ScienceDIrect)
  • FDA Grants Edison Pharmaceuticals' EPI-743 Orphan Status for Friedreich's Ataxia (Press)
  • Furiex Pharmaceuticals Announces Positive Top-Line Results of Two Pivotal Phase III Clinical Trials of Eluxadoline in Patients with IBS-d (Press)
  • Eisai's lenvatinib meets primary endpoint in Ph III thyroid cancer study (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

  • Ten Drug Companies Form Pact With NIH to Find Paths to New Medicines (WSJ-$) (SCRIP-$) (Bloomberg)
  • Broken Economic Incentives Require New Business Models for Antibiotics, Says CDC Antimicrobial Resistance Working Group Member (FDA Law Blog)
  • Advocates Worry That Drug Company Assistance Programs Will Be Banned From Helping Patients With Marketplace Policies (Kaiser)
  • Pay For Delay -- Supreme Court's Actavis Decision Is Limited to Monetary Payments (FDA Lawyers Blog)
  • FDA's Pediatric Anesthesia Research (FDA)

US: Medical Devices

  • FDA approves pediatric use of Dexcom's G4 Platinum continuous glucose monitoring system (FDA) (Press)
  • Ethics Questions Arise as Genetic Testing of Embryos Increases (NYTimes)
  • Meetings: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (FDA)
  • VuCOMP Announces Approval and Availability of Third-Generation M-Vu Computer-Aided Detection (CAD) System (Press)

US: Dietary Supplements

  • NPF Refers 40 Cases to FTC and FDA (NPI)
  • Doctors tend to be wary of supplements and don't routinely recommend them (Washington Post)

US: Assorted And Government

  • Former FDA Regulatory Counsel Joins Venable in Washington Office (NPI)(Press)
  • Eshoo, Pallone Battle For Top Dem Spot On Energy & Commerce; Bring Differing Health Care Focuses (IHP-$)

Upcoming Meetings And Events

  • 4 February 2014: FTC Biosimilars Workshop (FTC)
  • 5 February 2014: FDA Science Board Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

India

  • Indian industry refutes US IP index that red-flags 3(d) ripple effect (SCRIP-$)
  • Mylan launches biosimilar Herceptin in India (SCRIP-$) (India Times)
  • India's CCI Issues Edict Against Drug Industry Anti-Competitive Practices (PharmAsia-$)
  • Regulatory update on Indian clinical research approval timelines (Pharma Letter-$)

Japan & China

  • Why Did One Of The World's Largest Generic Drug Makers Exit China? (Forbes)

Other International

  • Australia: Medtronic's Deep Brain Stimulation, Spinal Cord Stimulation, Infusion Pump Devices Recalled (TGA) (TGA)
  • Mexico: Genzyme's Lemtrada Approved in Mexico for Treatment of Multiple Sclerosis (Press)

General Regulatory And Interesting Articles

  • Eyes On Excipients: Inactive but essential drug ingredients are getting checked out with modern rigor to ensure their quality (CEN)
  • HPV Vaccine Doesn't Promote Riskier Sexual Behavior In Teens (NPR)
  • PillPack Starts Offering Online, Personalized Prescription Service (Xconomy)

Regulatory Reconnaissance #249 - 4 February 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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