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Journal Cover   The RPM Report
   Full-text available via subscription Subscription journal
   ISSN (Online) 2160-4665
   Published by Informa plc Homepage  [14 journals]
  • Genentech’s Actemra Receives Breakthrough For
           Systemic Sclerosis; Potential Future Beneficiary of OPEN ACT'
    • Abstract: The potential new indication for Actemra could be an early beneficiary of a six-month patent extension, if the Cures legislation is enacted and orphan designation exclusivity remains a feature of the bill.
      PubDate: Wed, 17 Jun 2015 15:15:01 -040
  • PCSK9 Cholesterol Drugs And FDA’s Missing Mandatory Study Authority
    • Abstract: FDA has some work to do to interpret the Endocrinologic & Metabolic Drugs Advisory Committee’s advice about whether and when LDL-lowering can be treated as a fully valid surrogate endpoint to support approval. The issue would probably be a lot simpler for FDA—and the sponsors of a new class of highly effective LDL-lowering therapies—if FDA had authority to mandate trials for efficacy.
      PubDate: Wed, 17 Jun 2015 15:05:00 -040
  • Patient-Focused Drug Development: Moving Up The Development Timeline
    • Abstract: The patient-focused drug development effort initiated in PDUFA V has been flagged as a success by FDA and industry since it began, and the program is certain to be updated as part of PDUFA VI – if not early as part of the pending 21st Century Cures bill. The key objectives shared by stakeholders: broadening and systematizing patient input, and finding ways to bring it directly into the regulatory process.
      PubDate: Wed, 17 Jun 2015 11:30:01 -040
  • Development and Use of Patient Experience Data
    • Abstract: Here is an excerpt from the House “21st Century Cures” bill defining the key elements of a new process to collect “patient experience data,” under Title II, Subtitle A, “Patient-Focused Drug Development.”
      PubDate: Wed, 17 Jun 2015 11:15:01 -040
  • FDA “Approves” Amarin Vascepa Off-Label Campaign; Industry
           Groups Urge Court Not To Take The Bait
    • Abstract: FDA has given Amarin the go-ahead to disseminate results from the ANCHOR trial despite rejecting an explicit claim based on the study. That sounds like good news – except that it comes in the context of ongoing litigation, and amounts to an attempt to render the case irrelevant without surrendering control over off-label dissemination policies.
      PubDate: Tue, 16 Jun 2015 13:25:01 -040
  • Double Time on Double Dipping: CMS Proposed Rule Puts Pressure On Medicaid
           Managed Care
    • Abstract: New rules on Medicaid managed care plans step up the reporting requirements for tracking drug utilization to assure timely and accurate rebate invoicing. They also include a potentially important clarification on who is responsible for preventing “double-dipping” on 340B products.
      PubDate: Fri, 12 Jun 2015 10:50:02 -040
  • Copaxone And Complex Generics: Difficult-To-Copy Does
           Not Mean Impossible
    • Abstract: FDA’s approval of the first ANDA for an MS therapy signals the agency’s determination to find a way to get generic versions of complex drugs to market. What if any lessons does that hold for biosimilars?
      PubDate: Wed, 03 Jun 2015 16:05:00 -040
  • Antibiotic Incentives Moving Forward: “Cures” Act Pathway May
           Apply More Broadly
    • Abstract: Anti-infective drug development companies appear set to receive another round of legislative incentives as the “Cures” process moves forward. The only question is when and how much they will receive.
      PubDate: Tue, 02 Jun 2015 14:05:01 -040
  • A “Tipping Point” For Response To Anti-Microbial Resistance
    • Abstract: FDA’s Acting Commissioner Stephen Ostroff addressed the ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens on May 8. He began by noting it had been three years since the last meeting of the group – and highlighted how much has changed in the level of attention to address antimicrobial resistance in the interim.
      PubDate: Tue, 02 Jun 2015 09:55:00 -040
  • “Breakthrough” Dose-Finding In Oncology
    • Abstract: The “Breakthrough” era in oncology drug development creates new stress points in the effort to accelerate time-to-market. One important one involves the age-old challenge of finding the right dose – particularly in an era when the old idea of pushing the dose no longer makes sense.
      PubDate: Mon, 01 Jun 2015 13:45:01 -040
  • The “Program” At Half-Time: Report Finds Happy Sponsors, But
           Tweaks Suggested
    • Abstract: Drug sponsors are enthusiastic about FDA’s new review “Program” for novel drug and biologic applications. But they also want to see some tweaks to make the review process even more efficient – ideas that are sure to be brought to the PDUFA VI negotiating table.
      PubDate: Fri, 29 May 2015 13:40:00 -040
  • Following Through On Breakthrough: What’s Next For FDASIA
    • Abstract: FDA is building a case for enhanced funding to support the “Breakthrough” therapy program and at the same time is working to educate sponsors on how to use the new program effectively. The 21st Century Cures process floated a proposal for a new “Breakthrough” approval pathway – though that idea has been dropped.
      PubDate: Thu, 28 May 2015 12:50:01 -040
  • FDA’s Deadline To Update “Off Label” Policy
    • Abstract: A new provision in the “21st Century Cures” bill would set a deadline for FDA to issue update its policy on off-label information dissemination. That deadline is likely to come in late 2017 – and it probably behooves FDA to act by then regardless of what happens in the Cures legislation.
      PubDate: Thu, 21 May 2015 15:20:03 -040
  • FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus
    • Abstract: CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.
      PubDate: Mon, 18 May 2015 10:55:02 -040
  • Precision Medicine Is Precisely Right Theme For Biopharma: Impact Of
           Therapy—Not Cost—Is Focus
    • Abstract: A Senate hearing on President Obama’s Precision Medicine initiative illustrates how while that theme plays for the biopharma sector. The focus was on the potential for highly effective targeted therapies to help patients—and even lower costs for the system.
      PubDate: Fri, 15 May 2015 12:55:04 -040
  • CV Outcomes Trials In Diabetes: First Results Suggest
           “Goalpost” Model Here To Stay
    • Abstract: The first FDA advisory committee review of post-marketing cardiovascular outcomes trials conducted under the CV safety requirements imposed by the agency in 2008 ended with clear votes in favor of new warnings for the affected products – and a less explicit but no less clear endorsement of the approach spelled out in the guidelines.
      PubDate: Mon, 11 May 2015 13:45:01 -040
  • GDUFA II Negotiations: Let the Saber-Rattling Begin
    • Abstract: The reauthorization of the Generic Drug User Fee Act isn’t going to be as straightforward as the PDUFA process has been for the past two decades. Instead, expect a replay of the first medical device fee renegotiation – with plenty of threats from industry to walk away from the program altogether, likely intended to end up with the best possible deal.
      PubDate: Wed, 06 May 2015 14:45:01 -040
  • FDA’s Caretaker: Acting Commissioner Ostroff’s Agenda
           Emphasizes Continuity
    • Abstract: Expect the “Breakthroughs” to keep moving at FDA under acting Commissioner Stephen Ostroff, and for the agency to continue to pay a lot of attention to antibiotics and abuse-deterrent formulations.
      PubDate: Fri, 01 May 2015 10:50:00 -040
  • PRO-ving Ground: FDA Review Teams Commit to Patient-Reported Outcomes
    • Abstract: FDA recently announced a significant step in furthering the development of patient-reported outcomes: the planned creation of a web-based compendium of clinical outcomes assessments, including PROs. But an even more significant sign that FDA is committed to developing new patient-reported endpoints came directly from reviewers – including some divisions that have not historically been out front on the issue.
      PubDate: Fri, 01 May 2015 10:25:01 -040
  • Get Your Priority Review Voucher, While They Last
    • Abstract: The approval of Retrophin/Asklepion’s Cholbam triggers the third pediatric rare disease priority review voucher – and the sunset provision in the statute authorizing the program.
      PubDate: Sat, 25 Apr 2015 00:00:01 -040
  • Six Years Later: FDA’s New Enforcement Paradigm
    • Abstract: FDA’s top compliance official, Howard Sklamberg, used his annual update to the Food & Drug Law Institute to reflect on the changes in FDA’s enforcement structure and authorities during the tenure of Margaret Hamburg, who stepped down after six years as Commissioner of FDA in April.
      PubDate: Fri, 24 Apr 2015 14:25:00 -040
  • Medicare “Doc Fix” Enactment: Why Biopharma Companies Should
    • Abstract: A rare outbreak of bipartisanship in health care legislation led to the enactment of a permanent replacement of the sustainable growth rate payment formula for physicians. The bill doesn’t directly affect biopharma companies – and that is a reason for industry to celebrate.
      PubDate: Fri, 24 Apr 2015 12:00:02 -040
  • Comparative Effectiveness Research and the Environment for Health Care
    • Abstract: During the last five years, there has beenenormous changes in the health care environment: the implementation of the Affordable Care Act and its many provisions, including the creation of PCORI; the development of health exchanges and a move toward value-based payments, most notably in Medicare programs. In the midst of all this change, what impact will comparative effectiveness research have on health care decision-making?
      PubDate: Fri, 17 Apr 2015 13:45:00 -040
  • Complexities of Precision Medicine: Managing Multiple Rx/Dx Combos in the
           Same Class
    • Abstract: What happens when multiple targeted therapies are approved by FDA, each with a unique companion diagnostic for the same biomarker? The health care system is ill-equipped to deal with that scenario, putting patients at risk if the wrong test is used to guide a treatment decision.
      PubDate: Thu, 09 Apr 2015 00:00:00 -040
  • 340B Hearing Underscores Era Of Oversight, But Rolling Back Discount
           Program Doesn’t Look Likely
    • Abstract: A House Energy & Commerce/Health Subcommittee hearing on the 340B drug discount program suggests there is bipartisan interest in legislation to enhance oversight of the program – but little interest in steps that might dramatically curtail the availability of discounted drugs to hospitals and other safety net providers.
      PubDate: Wed, 08 Apr 2015 00:00:00 -040
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