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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  [15 journals]
  • FDA Prepares For LPAD: Orphan Drug Approvals Are Model
    • Abstract: One of the bedrock consensus issues throughout the drafting of the “21st Century Cures” legislation has been that the bill should create a pathway for approval of new antibacterials for limited populations – known as LPAD. But what would it actually do?
      PubDate: Fri, 14 Aug 2015 11:25:09 -040
  • Hard Feelings: Allergan/Valeant Merger Fight Colors Tax Reform Hearing
    • Abstract: A Senate hearing on the impact of the US corporate tax code on foreign acquisitions is part of the growing momentum to reshape tax policy in ways that could help American biopharma companies. However, Allergan’s former CEO is having a hard time letting bygones be bygones.
      PubDate: Wed, 12 Aug 2015 16:35:00 -040
  • FDA Responds to Nagging Questions About “Lagging” Drug Review
    • Abstract: It’s a question FDA has heard on Capitol Hill throughout the 21st Century Cures process: Why can’t all drug review divisions keep pace with the approvals seen in the oncology office – and shouldn’t steps be taken to ease development pathways for “lagging” conditions like Alzheimer’s and rare diseases? In the face of a tougher “Cures” debate in the Senate, FDA issues a white paper to more fully outline its response.
      PubDate: Wed, 29 Jul 2015 15:05:01 -040
  • Cruz’ Take On “Cures”: Tea Party Senator Jumps Into FDA
           Reform Debate
    • Abstract: The House “21st Century Cures” got an odd hand-off to Senate consideration with a July 14 hearing in the Science Commerce/Space, Science & Competitiveness Subcommittee, chaired by Ted Cruz. The hearing was a sideshow, but one that bears watching.
      PubDate: Wed, 29 Jul 2015 14:55:01 -040
  • The Pharmacy Police' House Hearing Pushes CMS To Do More To Limit
           Opioid Abuse In Part D
    • Abstract: The 21st Century Cures legislation provides CMS with new authority to limit Part D beneficiary access to pharmacies and providers when there is concern about misuse or abuse of prescriptions. Now legislators want CMS to do even more.
      PubDate: Thu, 23 Jul 2015 09:25:01 -040
  • CMS Nursing Homes Regs Include Controls For Antibiotics And
           “Psychotropic” Drugs
    • Abstract: CMS’ proposed update to nursing home regulations would include new pharmacy procedures intend to assure appropriate use of antibiotics and “psychotropic” drugs. The agency is also inviting nursing homes to impose monitoring on other classes, like anticoagulants.
      PubDate: Wed, 22 Jul 2015 16:30:01 -040
  • CMS’ Proposed “Pharmacy Services” Standards For
           Long-Term Care
    • Abstract: Here is CMS’ discussion of the proposed new “Pharmacy Services” requirements for long-term care facilities in the proposed rule released July 16.
      PubDate: Wed, 22 Jul 2015 16:25:01 -040
  • Crohn’s/Colitis Foundation Launches “IBD Plexus”;
           Data-Linking Project Is Step Towards Personalized Therapy
    • Abstract: The Crohn’s and Colitis Foundation of America is working on a platform to aggregate clinical, biosample and derived “omic” data across multiple cohorts. That’s worth watching as another step in the increasingly sophisticated and ambitious efforts by disease advocacy groups to collect, process and share data in specific conditions.
      PubDate: Mon, 13 Jul 2015 09:45:00 -040
  • King v. Burwell Ruling Clears A Path For
           “Cures,” Avoids Disrupting ACA
    • Abstract: The pharmaceutical industry didn’t have as much at stake in the second major Supreme Court ruling on the Affordable Care Act – but should still be celebrating the decision to upheld the Administration’s approach to exchanges.
      PubDate: Mon, 13 Jul 2015 09:25:02 -040
  • Defending FDA’s Off-Label Policy: What Are The Alternatives'
    • Abstract: As part of FDA’s defense in a First Amendment case filed by Amarin, the agency’s Janet Woodcock submitted a declaration outlining the government interests at stake – and explicitly responding to alternative approaches that a federal appeals court suggested in the landmark Caronia ruling that opened the door for Amarin’s suit. Here is an excerpt from the declaration responding to those alternatives.
      PubDate: Wed, 08 Jul 2015 15:59:55 -040
  • ALS Association Drafting Drug Development Guidance; Learning From DMD
    • Abstract: A Lou Gehrig’s disease patient advocacy group is moving forward with a drug development guidance of its own to the jumpstart the regulatory approval process.
      PubDate: Tue, 07 Jul 2015 16:45:02 -040
  • 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
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