Regulatory Recon: ASCO-Palooza—The Data You Need to Know (2 June 2014)

Posted 02 June 2014 By Alexander Gaffney, RAC

placeholder+image

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • ASCO 2014 Conference: A Torrent of Promising Results
  • FDA permits Teva, Mylan to market generic Celebrex (SCRIP-$) (FDA) (AP)
  • FDA cancer chief says 'escalating' drug prices can't continue (Reuters)
  • Help Wanted: FDA Seeks Expert Consultants For Priority Projects (Pink Sheet-$)
  • DILI and Drug Development: A Regulatory Perspective (PubMed)
  • FDA Faces More Tech Hurdles After Clearing AERs Backlog, And Congress Is Watching (Pink Sheet-$)
  • FDA, ONC and FCC Encourage Stakeholder Engagement on Proposed Health IT Strategy and Framework (FDA)
  • MDMA Pushes For Smaller-Scale Parallel Review To Reduce Data Burden (IHP-$)
  • Coalition calls for single regulation of IVDs, LDTs (BioCentury) (Comments)

In Focus: International

  • EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD (Eisner)
  • Rumors rumble on as to who will take over medtech reg file at EU Parliament (Clinica-$)
  • CDSCO rebuts concern over quality of Indian made drugs; will clarify its stand at ICDRA (PharmaBiz)
  • China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China (IPQ-$)

US: Pharmaceuticals/Biotechnology

  • FDA permits Teva, Mylan to market generic Celebrex (SCRIP-$) (FDA) (AP)
  • FDA cancer chief says 'escalating' drug prices can't continue (Reuters)
  • Help Wanted: FDA Seeks Expert Consultants For Priority Projects (Pink Sheet-$)
  • FDA approves Omeros eye drug, shares rise (Reuters) (Press)
  • DILI and Drug Development: A Regulatory Perspective (PubMed)
  • FDA Faces More Tech Hurdles After Clearing AERs Backlog, And Congress Is Watching (Pink Sheet-$)
  • Drug Recalls Soared Again in 2013, Driven by Contamination (Gold Sheet-$) (Gold Sheet-$)
  • QbD Update: More Science-Based Submissions but Also More Questions and Confusion (Gold Sheet-$)
  • Generics: Clarification of the Stability Clarification Front and Center! (Lachman)
  • Pitts, Pallone Introduce Bipartisan Legislation to Crack Down on Anabolic Steroids (Press) (NPI)
  • Safety Surveillance Using Real-time Medical Records Starts With Anticoagulant Pilot (Pink Sheet-$)
  • Alexion Pharma recalls certain lots of intravenous drug Soliris (Reuters) (Press)
  • YODA Draft Data Release Policy open for comment (AllTrials)
  • Pradaxa Medicare Study: Observing a Slow Attitude Change at FDA on Observational Studies (RPM Report-$)
  • FDA Releases Text of Form 483 to Morton Pharmaceuticals (FDA)
  • Pfizer To Pay $325M To End Neurontin Off-Label Suit (Law 360-$)

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

  • ASCO 2014: Winners and Losers (Forbes)
  • ASCO 2014: Pharmacyclics, Janssen's Imbruvica shines in CLL (SCRIP-$) (Press) (Reuters) (The Street) (NBC) (Pharma Times) (Fierce)
  • ASCO 2014: Clovis, AstraZeneca face off with EGFR, PARP inhibitors (SCRIP-$) (PMLive) (Press) (Reuters)
  • ASCO 2014: Cheap Drug Greatly Boosts Prostate Cancer Survival (AP) (NYTimes)
  • ASCO 2014: Drug Saves Fertility for Women With Cancer (NYTimes) (CBS) (AP) (Reuters)
  • ASCO 2014: Takeda's Velcade Significantly Improved PFS Compared to Standard Therapy as Frontline Treatment of Patients with Mantle Cell Lymphoma in Phase 3 Study (Press)
  • ASCO 2014: Astellas' Xtandi Aces PhIII PREVAIL Trial (Press)
  • ASCO 2014: GSK misses survival endpoint with Tykerb-Herceptin pairing (Fierce) (Press)
  • ASCO 2014: ARIAD Announces Preliminary Safety and Efficacy Data of Ponatinib in Patients with Newly Diagnosed CML from Discontinued Phase 3 EPIC Trial (Press)
  • ASCO 2014: Bristol's Yervoy, alone or in combo, improves melanoma results: studies (Reuters) (Press)
  • ASCO 2014: Lilly Drug Extends Survival in Advanced Lung Cancer Patients (The Street) (Forbes) (Fierce) (Reuters)
  • ASCO 2014: Merck immune system-booster effective in skin, lung cancer (Reuters) (Bloomberg)
  • ASCO 2014: ASCO: Time to Change Lung Cancer Surrogate Endpoint? (MedPage Today)
  • ASCO 2014: Roche Wins Breakthrough Product Designation for its MPDL3280A (Fierce) (Press) (Reuters) (SCRIP-$)
  • ASCO 2014: Eisai's Lenvatinib Shows Improved PFS in Thyroid Cancer in PhIII Study (Press)
  • ASCO 2014: Tesaro Summarizes Phase 3 Rolapitant Data (Press)
  • Forest Labs' Nebivolol/Valsartan FDC Meets Primary, Secondary Endpoints (Press)
  • Can-Fite Announces that the US FDA has Agreed with its Phase II Liver Cancer Protocol (Press)
  • Orexigen Announces June 11, 2014 PDUFA Action Date for NB32 (Press)

US: Pharmaceuticals and Biotechnology: General

  • Did Retrophin's CEO Share More Than Good Cheer in Twitter Posts? (Bloomberg)
  • Oncology society: Doctors need to consider benefits, side effects and price equally (MedCityNews) (Fierce)
  • Payers “Need A Bigger Boat” To Take On Pricing Like Sovaldi’s – Kaiser Permanente Exec (Pink Sheet-$)
  • Capturing cancer drugs’ true value calls for clear thinking (BioWorld)

US: Medical Devices

  • FDA, ONC and FCC Encourage Stakeholder Engagement on Proposed Health IT Strategy and Framework (FDA)
  • MDMA Pushes For Smaller-Scale Parallel Review To Reduce Data Burden (IHP-$)
  • Coalition calls for single regulation of IVDs, LDTs (BioCentury) (Comments)
  • ONC realigns organizational structure (Fierce)
  • SpringTMS Transcranial Magnetic Stimulator for Treatment of Migraines FDA Cleared  (MedGadget)
  • FCC Seeks Comment on Shared Commercial Operations in the 3550-3650 MHz Band (FR)
  • Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials? (PubMed)
  • Cytotoxic Evaluation of Nanostructured Zinc Oxide (ZnO) Thin Films and Leachates (PubMed)
  • OsteoSymbionics Announces FDA 510(k) Clearance for Using Novel Sterile Processing Process for ClearShield Implants (Press)

US: Dietary Supplements

  • Fabricant Transitions from FDA to NPA (NPI)
  • Avoiding Regulatory Pitfalls: GRAS, NDIs and Border Detention (NPI)

US: Assorted And Government

  • Something Less Than an Ideal Scenario for FDA's FY 15 Budget (Strengthen FDA)
  • House committee aide joins Bayer (The Hill)
  • PhRMA Loses Case Against FTC (DC Court)

Europe

  • EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD (Eisner)
  • EU Blocks Further Limits on Human Embryo Research, Backlash Hits (PharmExec)
  • Rumors rumble on as to who will take over medtech reg file at EU Parliament (Clinica-$)
  • The EUnetHTA Plenary Assembly provides important guidance on the future of HTA in Europe (EUnetHTA)

India

  • CDSCO rebuts concern over quality of Indian made drugs; will clarify its stand at ICDRA (PharmaBiz)
  • Several India Drug Makers Try, But Fail To Develop New Molecules (PharmAsia-$)

Japan & China

  • China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India and Brazil Among Countries Reviewing Excipient Regulatory Upgrades (IPQ-$)

Canada

  • CAN/CSA C22.2 No. 60601 Standard Changes (Eisner)

General Regulatory And Interesting Articles

  • A Massive Quest Begins To Find Good Genes That Protect Us From Deadly Ones (Forbes)
  • Breast Cancer Gene Also Causes Lung Cancer (NBC)

Regulatory Reconnaissance #329 – 2 June 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.

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

Share this article:

Categories: Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community