Regulatory Focus™ > News Articles > Regulatory Recon: Iressa Approved in New Patient Population for First-Line Lung Cancer Therapy (14 J

Regulatory Recon: Iressa Approved in New Patient Population for First-Line Lung Cancer Therapy (14 July 2015)

Posted 14 July 2015 | By Michael Mezher 

Regulatory Recon: Iressa Approved in New Patient Population for First-Line Lung Cancer Therapy (14 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • AstraZeneca Iressa and Companion Diagnostic Approved for Lung Cancer Therapy (Reuters) (SCRIP-$) (PharmaLetter-$) (MedScape) (GenomeWeb)
  • Experts Urge Sparing Use of Nonaspirin Painkillers (NYTimes)
  • Draft Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices (FDA)
  • FDA's Take-it-Slow Biosimilars Approach: Best for Industry? (SCRIP-$)
  • Big Money Hinges on Rules for Names of Biotech Generics (Boston Globe)
  • FDA Warns Against Off-Label Atrial Fib Use of Lariat Device (FierceMedicalDevices) (MassDevice) (FDA)
  • FDA Classifies Ventilator Recall as Class I After Software Causes Freeze (FierceMedicalDevices) (FDA)

In Focus: International

  • ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says (Pink Sheet-$)
  • Greece Bans Re-Export of 25 Drugs to Fight Abuses (Reuters)
  • India Looks To Rebuild Shaken Confidence in Trials Industry (PharmAsiaNews-$)
  • PhRMA Keeps an Eye on Indian Compulsory License Activity (SCRIP-$)
  • Digital Evolution for Ground-Breaking Yellow Card Scheme (MHRA)
  • US FDA Bans Emcure Pharma's India Plant Over Manufacturing Issues (Reuters)

US: Pharmaceuticals and Biotechnology

  • Experts Urge Sparing Use of Nonaspirin Painkillers (NYTimes)
  • Pfizer Discontinues Non-Abuse Deterrent Morphine Avinza (MPR) (FDA)
  • Scientists Develop Effective Method to Combat Bacteria by Engineering Nanoscale Particles (InfectionControlToday)
  • AstraZeneca Iressa Approved for First-Line Lung Cancer Treatment (Reuters) (SCRIP-$) (PharmaLetter-$)
  • Citizen Petition Blasts Sanofi Surgical Device (MDDI)
  • Veloxis' Tacrolimus Clears FDA For Narrower Population Following Court Loss (Pink Sheet-$)
  • Catalent Hit With FDA Form 483 at North Carolina Plant (Outsourcing-Pharma)

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

  • Newron Receives FDA Orphan Drug Designation for Sarizotan for the Treatment of Rett Syndrome (Press)
  • FDA Approves Qiagen's Therascreen EGFR Test for AstraZeneca NSCLC Drug (GenomeWeb)
  • Allegro reports Phase II Luminate data in vitreoretinal disease (BioCentury)
  • Anacor Hits Home Run with Crisaborole Phase III Trials (BioSpace) (FierceBiotech) (PharmaLetter-$)
  • Ohr Pharma’s OHR-102 shines in Phase II study for macular edema (PharmaLetter-$)
  • Scioderm to Submit Rolling NDA to U.S. FDA for Zorblisa (Press)
  • Effimune launches phase I clinical trial on immune system regulation control (MNT)
  • Blueprint Medicines Gets OK to Proceed with Clinical Trials for Two Cancer Drug Candidates (Press)
  • Aquila Solutions and  Evofem File New Drug Application for Amphora Contraceptive Gel (Press)

US: Pharmaceuticals and Biotechnology: General

  • FDA's take-it-slow biosimilars approach: best for industry? (SCRIP-$)
  • Big money hinges on rules for names of biotech generics (Boston Globe)
  • What is a Reference Standard? (USP Quality Matters)
  • Adverse effects of clinical trial data transparency - should we worry? (MNT)
  • Insulin Patches Could Replace Injections for Diabetics (Reuters)
  • Why Pharma might be especially interested in ResearchKit (MobiHealthNews)

US: Medical Devices

  • Draft Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices (FDA)
  • 5 Takeaways From FDA's Medical Device User Fee Workshop (Law360-$)
  • The New Gold Standard for Medical Device Performance (MDDI)
  • MRI-powered millirobots for minimally invasive surgery (MassDevice) (Vector)
  • Pulmonx Sham-Controlled Trial Exceeds Endpoints for Endobronchial Valve (MassDevice)
  • FDA classifies ventilator recall as Class I after software causes freeze (FierceMedicalDevices) (FDA)
  • FDA Warns Against Off-Label Atrial Fib Use of Lariat Device (FierceMedicalDevices) (MassDevice) (FDA)
  • How Device Makers Lose When Medicare Bundles Knee, Hip Surgery Fees (Forbes)

US: Assorted and Government

  • The Right to Try Act of 2015 –A Serious Challenge to FDA Control of Expanded Access? (FDA Law Blog)
  • Policy Briefs: What's New From FDA And CMS (Gray Sheet-$)

Upcoming Meetings and Events

Europe

  • Digital evolution for ground-breaking Yellow Card Scheme (MHRA)
  • Greece bans re-export of 25 drugs to fight abuses (Reuters)
  • Thoratec wins CE Mark for HeartMate PHP (MassDevice) (MedGadget) (Press)
  • Bayer's Gadovist Indication Expanded for use in Children Less Than Two Years of Age (Press)
  • Scottish Medicines Consortium OK's Five New Drugs for Coverage (EuropeanPharmaceuticalReview)

India

  • India Looks To Rebuild Shaken Confidence In Trials Industry (PharmAsiaNews-$)
  • US FDA bans Emcure Pharma's India plant over manufacturing issues (Reuters)
  • India moving closer to implementing price controls on medical devices (FierceMedicalDevices)
  • DCGI's mobile drug testing labs to check fake medicines (Economic Times)

China

  • China Ups Penalties for Quality Violators Under Tougher Regulation (PharmAsiaNews-$)
  • Roche gets NSCLC nod for Avastin from China FDA (FiercePharmaAsia)
  • Aoxing Pharma Announces Positive Trial Results for Opioid Dependence Treatment Ahead of CFDA Filing (Morningstar)
  • China's Aim to Halt Malaria Gets a Thumbs Up From WHO as Global Effort Grows (FiercePharmaAsia)

Canada

Australia

  • TGA Unveils New Format for Public Assessment Reports (TGA)

Ebola Outbreak

  • Inhaled Ebola Vaccine Stops Virus in Monkeys, Study Finds (NYTimes)

Other International

  • ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says (Pink Sheet-$)
  • Taiwan-Based Lorati Claims AIDS Treatment Breakthrough (PharmaLetter-$) (Press)
  • UN achieves HIV treatment target 9 months early (OnMedica)
  • Study Finds Donor Funds Fall Short for Key Global Health Functions (InfectionControlToday

General Regulatory and Interesting Articles

  • Caveats, costs and complexities shadow first malaria vaccine (Reuters)
  • Waiting To Pick Your Baby's Name Raises The Risk For Medical Mistakes (NPR) (Reuters)
  • How 3-D printing helped a Canadian rooster strut again (Washington Post)

Regulatory Reconnaissance #595 – 14 July 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 @Michael_Mezher 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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