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Journal Cover The RPM Report
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   Full-text available via subscription Subscription journal
   ISSN (Online) 2160-4665
   Published by Informa plc Homepage  [16 journals]
  • Changing the Subject (Part 2): Turning Turing Around By Offering A
           “National Center Of Pharmaceutical Supply”
    • Abstract: Rather than try to “win” the drug pricing debate, the biopharma sector may be better served by coming up with new ideas to change the subject. We outlined our case for taking this approach – and the model for ideas that serve that goal – here.
      PubDate: Wed, 25 May 2016 15:20:00 -040
       
  • Changing The Subject (Part 1): Stop Trying To “Win” The Drug
           Pricing Debate
    • Abstract: When it comes to pricing, it is worth remembering that the interests of buyers and sellers can never be truly aligned. So rather than trying to “win” the drug pricing debate, the pharmaceutical industry may be better served by steering it into new areas.
      PubDate: Wed, 25 May 2016 15:15:00 -040
       
  • Aegerion Juxtapid Settlement Shows REMS Have Teeth:
           Alternate Route To Enforce Off-Label'
    • Abstract: Who says FDA can’t bring off-label cases? They may just morph into REMS violation cases – if, that is, FDA starts using the REMS authority more often.
      PubDate: Wed, 18 May 2016 13:55:01 -040
       
  • New Scheduling Schedule: DEA Meets 90-Day Deadline For UCB’s
           Briviact
    • Abstract: UCB’s Briviact (brivaracetam) is the first product cleared under a new accelerated process for new molecular entities subject to the Controlled Substances Act scheduling process. Will the focus shift to FDA’s timelines next?
      PubDate: Mon, 16 May 2016 00:00:13 -040
       
  • Podcast: Presidential Politics and Healthcare Impact (Part II)
    • Abstract: In Part II of our conversation with political analyst Chris Krueger, we discuss the most recent update on Donald Trump and Hillary Clinton, Clinton’s public option proposal, the new VP list, and first term priorities for either candidate. Click here to listen.
      PubDate: Wed, 11 May 2016 15:30:01 -040
       
  • Mandatory Education For Advisory Committee Members'
    • Abstract: FDA’s advisory committee review of the opioid REMS ended with a strong recommendation for mandatory education for prescribers of opioids. Some of the discussion suggested the need for more education of the advisory committee members.
      PubDate: Tue, 10 May 2016 14:40:00 -040
       
  • A New Type of Investor Relations for Biopharma
    • Abstract: The biopharma industry is facing strong pressure to justify its pricing practices. And not just from politicians.
      PubDate: Tue, 10 May 2016 13:20:00 -040
       
  • Rethinking Oncology Development: Master Protocols May Shorten Time To
           Approval
    • Abstract: Master protocols that allow for the simultaneous study of multiple agents will shave more time off in the clinic than one-off studies in small groups of patients, FDA’s Janet Woodcock predicted. The current timeframes in oncology development are “unacceptable,” and can be shortened, she said, by “doing things differently.”
      PubDate: Wed, 04 May 2016 00:00:00 -040
       
  • Breakthrough Nears 50 Approvals: Process Improving, But “Gray
           Areas” Persist
    • Abstract: FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
      PubDate: Mon, 02 May 2016 12:55:01 -040
       
  • Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development
    • Abstract: Patient-reported outcomes in oncology clinical trials remain an infrequently used tool, despite acknowledgement by sponsors that the patient experience is important to measure – and encouragement from FDA officials to do so. The lack of PROs in oncology may be a byproduct of the fast pace of cancer drugs are developed in the U.S.: small trials and accelerated pathways.
      PubDate: Wed, 27 Apr 2016 15:30:00 -040
       
  • Putting the Patient in Labeling (And Drug Approval Decisions) in ODE 1
    • Abstract: The Office of Drug Evaluation 1 (Cardio-Renal, Neurology, and Psychiatry) remains a bastion of FDA traditionalism. The long-time spiritual/intellectual leader of the group, Bob Temple, has been cautious about how to accept patient input into FDA approval criteria for drugs reviewed in these areas.
      PubDate: Tue, 26 Apr 2016 12:35:01 -040
       
  • High Prices And High Taxes: Do They Go Together'
    • Abstract: Here’s how one biopharma CEO wants to turn the criticism of high drug prices into support for corporate tax reform.
      PubDate: Fri, 22 Apr 2016 12:50:01 -040
       
  • Podcast: A Conversation On Presidential Politics and HealthCare Impact
    • Abstract: Political analyst Chris Krueger discusses Donald Trump and Hillary Clinton, potential election outcomes, HHS Secretary choices, the Supreme Court and the ACA, and possible legislative initiatives on tax reform and drug pricing in 2017. Click here to listen.
      PubDate: Thu, 21 Apr 2016 14:45:00 -040
       
  • NIH Reluctant To “March In”: Collins Suggests Authority Not
           Intended To Address Pricing Concerns
    • Abstract: Legislators are urging the National Institutes of Health to use intellectual property levers to put pressure on prescription drug pricing. NIH has historically been reluctant to play the role of the price police – and it still is.
      PubDate: Wed, 20 Apr 2016 13:05:02 -040
       
  • A “Precedent-Setting” OTC Switch – And A Case Study In
           Disregarding FDA’s Advice
    • Abstract: Galderma’s OTC switch application for the acne therapy Differin (adapalene 0.1% gel) cleared an important milestone with a unanimous vote in favor of approval from an FDA advisory committee April 15. FDA urged the committee to consider the application as “precedent setting” given the theoretical risk of teratogenicity – but one committee member was more worried about the bad precedent of approving an application for a sponsor that didn’t do a label comprehension study they way FDA requested.
      PubDate: Tue, 19 Apr 2016 08:35:02 -040
       
  • Watchful Waiting On Drug Prices In Part D
    • Abstract: CMS is shaking things up in Medicare Part B with a proposed demonstration project to test alternative reimbursement models for prescription drugs. But in Part D, CMS is taking more of a wait-and-see approach – at least in the annual update to the rules for bids on offering the insurance benefit.
      PubDate: Fri, 15 Apr 2016 09:15:01 -040
       
  • Cancer “Moonshot” Launch Team Announced: Uncomfortable Ties To
           Anti-Industry Headlines
    • Abstract: The Vice President’s cancer “moonshot” is a great opportunity for biopharma companies to engage in a process that should remind policymakers and the public of the promise of biomedical innovation at a time when the industry’s pricing and financial engineering activities are under scrutiny on Capitol Hill. The selection of the “blue ribbon” panel puts those two images in stark contrast.
      PubDate: Wed, 13 Apr 2016 15:26:00 -040
       
  • CDER Brand Name Reviews: Predictability Returns To Process
    • Abstract: FDA’s Center for Drug Evaluation & Research is now granting 86% of drug sponsors’ preferred proprietary trade names prior to launch – a significant improvement over just five years ago. Better communication between FDA and drugs sponsors – including the development of several new guidance documents – has resulted in a much more predictable review of proprietary trade names.
      PubDate: Tue, 12 Apr 2016 13:55:00 -040
       
  • Restoring FDA’s Confidence In Labeling
    • Abstract: FDA’s decision to harmonize immediate-release and extended-release opioid labeling is an important step to address a political vulnerability for the agency and its new commissioner. But Commissioner Califf’s discussion of the role of FDA-approved labeling may be more important as an indicator of the overall drug approval climate – and a path forward in the thicket of First Amendment challenges to the agency’s marketing oversight.
      PubDate: Thu, 07 Apr 2016 11:30:00 -040
       
  • FDA’s Message To Patient Advocates: Efforts On Engagement Are Only
           The Beginning
    • Abstract: Food & Drug Administration officials used a day-long public meeting to reassure patient advocates that the agency’s efforts to enhance patient engagement in the drug development process have only just begun, and that many more steps will need to be taken before FDA can deem patient-focused drug development a complete success.
      PubDate: Wed, 06 Apr 2016 11:00:01 -040
       
  • FDA Vs. The Three-Second Rule
    • Abstract: FDA’s crackdown on Indian manufacturing facilities continues four years after FDASIA boosted overseas inspection reports. The Warning Letters continue to paint an unflattering picture of practices at some sites.
      PubDate: Tue, 05 Apr 2016 10:15:00 -040
       
  • FDA’s Next Step to Real-World Evidence: Prove That Real-World
           Studies Can Match Known RCT Results
    • Abstract: Industry is eager to develop approval pathways that rely on “real world” evidence from insurance claims and electronic health records. FDA, however, thinks the next step needs to be develop and validate the methodology.
      PubDate: Tue, 29 Mar 2016 00:00:09 -040
       
  • Thinking Outside The Box On Rx Pricing: From Vaccines To Part D Bundling
    • Abstract: Former FDA Deputy Commissioner suggest Vaccine-For-Children model for high value drug purchasing programs during Johns Hopkins drug pricing conference. Bundled payments in Part D is another option put on the table.
      PubDate: Fri, 25 Mar 2016 00:00:00 -040
       
  • FDA “Intercenter Institutes” Legislation Headed For Senate
           Mark-Up
    • Abstract: FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area under legislation proposed in the Senate. The idea of further integrating medical product reviews is already part of the Vice President’s cancer “moonshot.”
      PubDate: Mon, 21 Mar 2016 11:35:01 -040
       
  • Podcast: A Conversation with FDA’s OPQ Director Michael Kopcha
    • Abstract: Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.
      PubDate: Tue, 15 Mar 2016 11:40:00 -040
       
 
 
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