RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer raises US prices of 91 drugs by 20% in 2017 ( Financial Times ) ( Reuters ) Loxo's targeted drug helps variety of advanced cancers in small study ( Forbes ) ( Endpoints ) ( Reuters ) ( Xconomy ) ( Financial Times ) ( The Street ) ( STAT ) AstraZeneca's Lynparza Slows Breast Cancer Caused By BRCA Mutations By 42% ( Forbes ) ( Reuters ) ( Financial Times ) ...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Expands Use of CF Drug ASCO Abstracts Released (18 May 2017)

    Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. In Focus: US                                       FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis ( FDA ) ( Spotlight ) House E&C to vote on user fees on Thursday ( E&C ) Trump Reportedly Considering New Cuts to Biomedical Research ( The Atlantic ) ( Stat ) ( MedPage Today ) ( SNL ) An "operating system for the brain" gets FDA approval...
  • Regulatory NewsRegulatory News

    Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

    In just its third untitled letter of the year (and the first in almost five months), the US Food and Drug Administration (FDA) on Tuesday called out Jazz Pharmaceuticals subsidiary Celator Pharmaceuticals for promoting an investigational drug in a panel at the American Society of Clinical Oncology’s (ASCO) annual meeting in June. The company promoted the investigational drug, which was previously granted a breakthrough therapy designation by FDA, with claims that it is...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Approves Allergan Combo Therapy Biden to Launch Database to Advance Cancer Research and More From ASCO 2016 (6 June 2016)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves Allergan's combination therapy for hypertension ( Reuters ) ( PR ) Teva Painkiller Resists Snorting, Injection Abuse, FDA Staff Say ( Bloomberg ) Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA ( PR ) ( Reuters ) Supreme Court rejects GSK bid to throw out racketeering lawsuits ( R...