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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  [13 journals]
  • “Physican-Directed Applications”: A Clinician’s Case To
           Open Up Off-Label Promotion
    • Abstract: In testimony during the House Energy & Commerce Committee’s “21st Century Cures” initiative, a rheumatologist makes the case for broader access to off-label use information – but not for eliminating FDA review before dissemination.
      PubDate: Thu, 24 Jul 2014 16:25:00 -040
       
  • Biotech Investors Howling At Yellen After Federal Reserve Report Roils
           Sector
    • Abstract: “Equity valuations” for biotech companies “appear to be stretched,” the Federal Reserve cautions. Biotech investors and analysts disagree.
      PubDate: Thu, 24 Jul 2014 11:00:01 -040
       
  • FDA May Emerge From Zohydro Approval Purgatory in
           October
    • Abstract: FDA could get relief this autumn from a year of political controversy stemming from the approval of Zohydro, thanks to two abuse-deterrent hydrocodone applications in the works from Purdue and Zogenix. 
      PubDate: Fri, 18 Jul 2014 12:40:00 -040
       
  • Two Takes On Sovaldi: Rep. Burgess Urges Rx And
           Insurers To Work It Out; Sen. Wyden Requests Details
    • Abstract: Health Subcommittee Vice Chair has some advice for payers and drug companies: work out your problems or face the growing pressure for government to get involved.
      PubDate: Fri, 18 Jul 2014 11:05:01 -040
       
  • Patient Advocacy And PDUFA VI: Next Steps Could Include Involvement In
           Reviews, More Scientific Briefings for FDA Staff
    • Abstract: Disease advocacy organizations are expanding their “honest broker” function in drug development into the early stages of the regulatory discussions. They are engaging in the patient-focused meetings established by PDUFA V and finding more ways to interact with FDA review staff on general development issues in their specific areas.
      PubDate: Fri, 18 Jul 2014 09:30:02 -040
       
  • Anti-Infective Incentives: GAIN, LPAD Won’t Be Enough
           HHS-Commissioned Report Finds
    • Abstract: The continuing government interest in incentives for antibacterial development got a boost from an unexpected quarter in June. A report commissioned by HHS calls for a broad package of incentives to stimulate continued investment in new anti-infectives.
      PubDate: Wed, 02 Jul 2014 10:45:03 -040
       
  • A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say
    • Abstract: Drug companies looking for a FDA-style Breakthrough Therapies pathway in Europe shouldn’t hold their breath: The current European health care reimbursement landscape, regulators say, cannot support a Breakthrough pathway. Europe is looking for other ways to shorten drug development times until the bigger-picture reimbursement question can be addressed.
      PubDate: Wed, 02 Jul 2014 08:30:01 -040
       
  • FDA Review “Program” Tweaks May Include Smaller Mid-Cycle
           Meetings
    • Abstract: Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V. Those numbers – which can sometimes include the entire FDA review team – have made mid-cycle conference calls difficult to schedule, especially for expedited products with tight review timeframes.
      PubDate: Mon, 30 Jun 2014 14:35:00 -040
       
  • “Non-Interference” And Part D: Prescriber Oversight Is Focus
           Of CMS Final Rule
    • Abstract: CMS’ final rule on Part D is much narrower than the agency’s proposed rule—and most in industry are probably pleased by that. But it is also much more one-sided, emphasizing new tools to monitor for and correct “abusive” prescribing, without any countervailing provisions reflecting the value of appropriate medication adherence.
      PubDate: Fri, 20 Jun 2014 08:50:05 -040
       
  • Provectus Breakthrough Denial Is Symptom Of a Different Breakthrough at
           FDA
    • Abstract: Provectus Pharmaceuticals raised a few eyebrows by raising the curtain on FDA’s rejection of its Breakthrough status application for its malignant melanoma drug. By making the letter public, the company shed light on the broader issue of how seriously FDA is taking symptom improvement as a component of clinical meaningfulness in some cancers.
      PubDate: Thu, 19 Jun 2014 17:00:10 -040
       
  • The Cancer Patent Cliff: Why Watchful Waiting May Be The Best Rx For High
           Drug Costs
    • Abstract: As efforts are made to try new reimbursement and pricing models to address concerns about the price of cancer drugs, one option is to wait and see if generics and biosimilars solve the problem.
      PubDate: Thu, 19 Jun 2014 16:30:00 -040
       
  • Public Policy and Big Pharma M&A: Prices, Patents and Taxes
    • Abstract: Big Pharma M&A is back in the headlines, though so far the biggest deals have been talked about but not completed. While the business elements of each of the deals are different, there are some common public policy themes.
      PubDate: Wed, 18 Jun 2014 14:15:06 -040
       
  • Sovaldi And The Case Against Incentives
    • Abstract: The House Energy &Commerce Committee’s “21st Century Cures” initiative has provided a very friendly forum for the biopharma industry to advance ideas to improve the public policy climate for innovation. However, not everyone agrees that more incentives mean more innovation.
      PubDate: Wed, 18 Jun 2014 13:45:00 -040
       
  • Cutting Cost in Oncology: MD Anderson Tries Episode-Based Payments
    • Abstract: At the Institute of Medicine’s National Cancer Policy Forum workshop, MD Anderson Cancer Center gave an update on its pilot to bundle payments using an episode-based model. The approach is less about the cost of drugs—and more about the overall cost of treatment.
      PubDate: Wed, 18 Jun 2014 11:06:00 -040
       
  • Innovative Medicine: The Balance Between Benefits and Costs
    • Abstract: There are two ongoing debates around the impacts of innovation in medicine: to what degree are rising health care costs attributable to new technologies and are those costs worth the outcomes benefit? “New or expensive” shouldn’t be the sole criteria for judging whether we adopt new therapies as a society.
      PubDate: Fri, 13 Jun 2014 15:05:00 -040
       
  • Seeking Guidance On Abuse-Deterrence: Sponsors Fall Short, Congress Urges
           Action
    • Abstract: Congressional appropriators are urging FDA to move quickly to finalize guidance on abuse deterrence claims for opioids—and to take the next step and prohibit marketing of products that don’t deter abuse. FDA says the science isn’t there yet, and two sponsors join the list of those who have failed to clear the hurdle.
      PubDate: Fri, 13 Jun 2014 11:45:00 -040
       
  • After REMS: An Interview With Amgen’s Paul Seligman
    • Abstract: Health care reform means a lot of things for the pharmaceutical industry. Will it also mean the end of REMS?
      PubDate: Mon, 09 Jun 2014 13:45:00 -040
       
  • The End of the REMS Era' Entyvio Approval Is
           Another Marker
    • Abstract: FDA approved Takeda’s UC and Crohn’s disease therapy without a REMS – even though the product has a theoretical risk of causing PML, based on its similarity to Biogen’s Tysabri.
      PubDate: Tue, 03 Jun 2014 14:50:03 -040
       
  • Pradaxa Medicare Study: Observing a Slow Attitude Change at FDA on
           Observational Studies
    • Abstract: CDER Deputy Director Bob Temple is a confirmed skeptic of the value of observational trial data to FDA’s regulatory decisions. A recent Medicare study on the bleeding risks associated with Boehringer-Ingelheim’s Pradaxa, however, confirmed an earlier position on the drug by FDA and meets with Temple’s approbation.
      PubDate: Thu, 29 May 2014 00:00:00 -040
       
  • Impact of CER Still on the Horizon, Say Health Care Stakeholders
    • Abstract: CER remains very visible on an as-yet unattainable horizon as a source for medical treatment evidence. That’s the picture from the National Pharmaceutical Council’s fourth year of surveying health care stakeholders on comparative effectiveness research.
      PubDate: Fri, 23 May 2014 00:00:00 -040
       
  • CDER’s New Quality Office Still Awaiting Final Sign Offs
    • Abstract: FDA’s proposed Office of Pharmaceutical Quality remains a personal and professional priority of CDER Director Janet Woodcock, and she determined to get the office up and running before the end of the fiscal year.
      PubDate: Mon, 19 May 2014 11:35:00 -040
       
  • Off-Label Policy: History And Legal Basis
    • Abstract: Here is the “background” section from FDA’s March draft guidance on reprint distribution. The section includes more than 20 footnotes (omitted here) that reflect an effort by FDA to update and buttress the legal basis for the prohibition on off-label promotion.
      PubDate: Mon, 19 May 2014 11:35:00 -040
       
  • The Roundtable Versus The Banquet Table
    • Abstract: There will be extensive jockeying for attention over the next year from House Energy & Commerce Chairman Fred Upton for the “3D’s” review of drug legislation. NORD was not at the kick-off Capitol Hill roundtable but may already have the chairman’s ear -- or at least his emotional backing.
      PubDate: Mon, 19 May 2014 11:20:00 -040
       
  • Proposing a Generic Labeling Change Could Land FDA With More Work
    • Abstract: Opponents of FDA’s November proposed rule on generic labeling don’t necessarily think the the best option is to maintain the status quo – but the other option is to give FDA more responsibility.
      PubDate: Fri, 16 May 2014 11:45:05 -040
       
  • Expanded Access Theme Is One Sour Note For Biopharma In
           “21st Century Cure” Roundtable
    • Abstract: The Energy & Commerce Committee “21st Century Cures” Process promises to set a pro-innovation tone heading into the next user fee reauthorization cycle. There is one theme, however, that may be perilous for industry moving forward: Expanded Access.
      PubDate: Thu, 15 May 2014 12:20:03 -040
       
 
 
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