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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  [13 journals]
  • 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
  • Dystrophin Disconnect' FDA Workshop Indicates Slow Pace Of Biomarker
    • Abstract: DMD applications are beginning to arrive at FDA – but the agency is still struggling to get a handle on a proposed biomarker to support their approval. That is a key implication from FDA’s day long workshop on how to measure dystrophin.
      PubDate: Fri, 03 Apr 2015 00:00:04 -040
  • Personalized Medicine Meets Payment Policy: MEDCAC Has “Low
           Confidence” In Most Cancer Tests
    • Abstract: Genomic screening of tumor types may be the cutting edge in cancer treatment and a central component of the President’s vision for personalized medicine. But how much evidence is necessary to make insurance coverage for testing routine?
      PubDate: Thu, 02 Apr 2015 12:10:01 -040
  • FDA’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA
           Through Process
    • Abstract: FDA’s Office of Hematology & Oncology Products will complete four to five streamlined reviews of supplemental oncology indications before reflecting on the “lessons learned” from the pilot program. After the successful review of Genentech’s Avastin for cervical cancer, FDA says that a second application has gone through the abbreviated process.
      PubDate: Wed, 01 Apr 2015 00:00:01 -040
  • Looking Forward At FDA: Hamburg’s Farewell Notes Challenges;
           Califf’s First Remarks Focus on Pediatrics
    • Abstract: FDA Commissioner Margaret Hamburg is leaving the agency on a high note – and taking the opportunity to urge stakeholders to avoid the temptation to push for changes that will “”weaken or undermine” the agency. Meanwhile, FDA's new Deputy Commissioner of Medical Products Robert Califf makes his first formal remarks in that role during a stakeholder meeting on pediatric research.
      PubDate: Tue, 31 Mar 2015 11:55:00 -040
  • Reopening The LABA Class: FDA Shepherds Breo Through
           Committee For Asthma
    • Abstract: A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive.
      PubDate: Fri, 27 Mar 2015 00:00:59 -040
  • Sitting Out The Patent Dance: Federal Judge Sides With Sandoz In
           Biosimilar Case
    • Abstract: The first biosimilar approved by FDA—Sandoz’ version of Amgen’s filgrastim—is cleared to launch after a federal court judge agreed with Sandoz that the “patent dance” provisions of the biosimilar law are optional, and that a requirement for 180-day notice prior to launch can be given before approval. Here is an excerpt from the ruling, marking the first judicial interpretation of those elements of the statute.
      PubDate: Fri, 27 Mar 2015 00:00:54 -040
  • FDA Outlines “Expedited” Review For Breakthrough Therapies;
           “Hyper-Fast” Reviews, Beyond Oncology
    • Abstract: Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.
      PubDate: Mon, 23 Mar 2015 11:25:01 -040
  • Reality Check For Real World Data: FDA’s Sentinel Network Enters
           “Production” Stage
    • Abstract: FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.
      PubDate: Mon, 23 Mar 2015 00:00:00 -040
  • LIGHT Data Release Raises Heavy Issues for Small Sponsors
    • Abstract: It was supposed to be good news: Orexigen announced a new patent for its weight loss drug Contrave, supported by strong CV safety data from the interim analysis of LIGHT. The controversy that followed underscores how hard it will be for small sponsors to satisfy FDA in the future when it comes to protecting interim data from long term outcomes trials.
      PubDate: Mon, 16 Mar 2015 13:00:00 -040
  • FDA Watching For “Unintended Consequences” of 21st Century
    • Abstract: Engaging in the House Energy & Commerce Committee’s “21st Century Cures” process and tracking any potential legislation will be a top priority in 2015, FDA’s Janet Woodcock says. Sometimes what seem like good ideas, she says, “have a lot of unintended consequences.”
      PubDate: Mon, 16 Mar 2015 11:30:02 -040
  • A Fitting Farewell: Hamburg Earns Praise From Rep. Rogers In Final Approps
    • Abstract: FDA Commissioner Margaret Hamburg and House Appropriations Chair Hal Rogers (R-KY) have had ups and downs over the years, but Rogers praised her and her legacy on prescription abuse.
      PubDate: Mon, 16 Mar 2015 11:00:00 -040
  • Direct-Acting Oral Anticoagulant Review Scorecard: Head-to-Head Study
           – of FDA Divisions
    • Abstract: The recent wave of therapies intended to replace warfarin as the gold standard anticoagulant therapy has been an important medical and commercial story for the biopharma sector in the past five years. It also offers an unusual opportunity to compare the approaches taken to reviews by two different divisions within FDA’s Office of New Drugs.
      PubDate: Wed, 11 Mar 2015 13:25:01 -040
  • SEC’s Warning To Biopharma: Report FDA Dialogue Accurately
    • Abstract: The Securities & Exchange Commission’s top enforcement official urges biopharma companies to disclose FDA correspondence as the best step to avoid potential compliance issues with the investor watchdog agency. Here is an excerpt from his remarks to the CBI Pharmaceutical Compliance Congress on March 3.
      PubDate: Mon, 09 Mar 2015 12:40:00 -040
  • Xyrem REMS Grudgingly Approved; FDA Worries About
           Blocked Generics
    • Abstract: FDA approves a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceutical’s Xyrem under protest; the agency says the single-pharmacy distribution plan for the narcolepsy treatment has the potential to block generic competitors from the market. FDA and Jazz had been working for seven years to agree to a REMS that confirms to the requirements under the FDA Amendments Act of 2007.
      PubDate: Thu, 05 Mar 2015 11:25:01 -050
  • REMS “Abuses” Concern FDA, But Can Scolding Help Speed Generic
    • Abstract: Brand name companies’ use of restricted distribution programs to block the development of generic drugs has been an unintended consequence of the FDA Amendments Act of 2007. The generics industry has long complained that the use of FDA-required risk management plans prevents access to affordable medicines.
      PubDate: Wed, 04 Mar 2015 11:20:01 -050
  • When An “Abysmal” Study Is Good Enough: Avedro CXL Therapy
           Clears FDA Committee
    • Abstract: Avedro Inc.’s CXL drug/device combination therapy for corneal cross-linking is not your typical new drug application. But a February advisory committee discussion of the application helps show the contours of the current regulatory climate for innovators at FDA.
      PubDate: Mon, 02 Mar 2015 14:36:00 -050
  • Biopharma Gains Ground On ACA Formularies
    • Abstract: CMS’ final rule on Benefit and Payment Parameters for the Affordable Care Act health exchange plans includes new formulary provisions that move a bit closer to the protections on access included in Medicare Part D. Now if only industry could get rid of specialty-tier-only classes.
      PubDate: Mon, 02 Mar 2015 13:55:00 -050
  • Overkilling Withdrawn Drugs: FDA Gives Thorough Reassessment For
           Do-Not-Compound List
    • Abstract: In its preparations for the first meeting of the rechartered Pharmacy Compounding Advisory Committee, FDA devoted considerable effort to defending the inclusion of two drugs on a list of products withdrawn for reasons of safety and efficacy (and therefore illegal to compound). FDA is understandably concerned about making an airtight case for future enforcement – but it sure seems like a lot of trouble for what should be the easiest task the agency faces in implementing the compounding law.
      PubDate: Fri, 20 Feb 2015 12:50:01 -050
  • CMS Returns To Part D Rule, But Steers Clear of Controversial Policies
    • Abstract: CMS is getting around to some unfinished business by finalizing some changes to the Medicare Advantage and Part D Drug benefit programs first laid out in a January 2014 draft proposal. The agency, however, is not trying to reopen the controversy that proposed rule set off.
      PubDate: Thu, 12 Feb 2015 17:10:01 -050
  • Thanks to FDASIA: Drug Shortages Declining, FDA Says
    • Abstract: Shortage reporting requirements in FDASIA have helped FDA reduce the number of drug shortages in recent years—in 2013, just 44 new drugs shortages were reported, down from 251 in 2011.
      PubDate: Wed, 11 Feb 2015 10:55:00 -050
  • Next Steps for Patient-Centered Drug Development: Room for More Input,
           With Limits
    • Abstract: Patient advocates are pushing the Food & Drug Administration to take the next step in the agency’s patient-focused drug development initiative and more directly incorporate the patient experience into regulatory decisions. While that’s a welcomed ask, FDA officials say, it’s not as easy as it looks.
      PubDate: Tue, 10 Feb 2015 16:10:00 -050
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