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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]
  • 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    • Abstract: Here is the “background” section from FDA’s March draft guidance on reprint distribution.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
  • FDA Adapts Drug Development Tool Procedures to Adopt Alzheimer’s
           Simulation Tool
    • Abstract: FDA recently featured an Alzheimer’s Disease clinical trial simulation tool as another positive, but low-visibility, step toward improving the drug development pathway for the disease. The process for accepting the tool may be as important as the tool itself.
      PubDate: Tue, 13 May 2014 15:40:02 -040
  • A Close Call: FDA’s Decision Memo On The Approval of Chelsea
           Therapeutics’ Northera
    • Abstract: On February 18, FDA granted accelerated approval to Chelsea Therapeutics’ Northera (droxidopa) for neurogenic orthostatic hypotension. The review was difficult, generating a “complete response” letter and a formal dispute resolution after the first cycle, and a negative primary review on the second go-around.
      PubDate: Mon, 12 May 2014 15:55:00 -040
  • $8 Billion And Counting: Pharma Paying Its ACA Taxes
    • Abstract: HHS OIG report shows pharma industry fee is being paid, albeit with a few bumps along the way.
      PubDate: Mon, 12 May 2014 12:40:01 -040
  • FDAAA Fading' REMS Use Continues To Decline As Drug Safety Law Matures
    • Abstract: FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
      PubDate: Mon, 12 May 2014 12:00:05 -040
  • Part D Proposed Rule Gone But Not Forgotten: Bill Would Bring “Any
           Willing Pharmacy” Provision Back
    • Abstract: CMS dropped the most controversial provisions from a proposed rule to overhaul Medicare Part D in the face of united opposition from the pharmaceutical industry, health plans, and patient advocacy groups. Now community pharmacy is pushing to restore one of those provisions via legislation.
      PubDate: Fri, 09 May 2014 08:20:02 -040
  • Acknowledging Caronia: FDA Takes The First Step To
           Rethinking Off-Label Policy
    • Abstract: FDA has gotten past the denial phase and now is listening to ideas on how to balance the need to preserve the integrity of the regulatory process with evolving interpretations of the First Amendment as it applies to commercial speech. That is slow but important progress – but towards what goal?
      PubDate: Thu, 01 May 2014 16:45:04 -040
  • Making The Most Of ACOs: How Biopharma Is Adapting To New Customer Segment
    • Abstract: ACOs have been one of the most hyped innovations in the US health care sector this decade. The buzz may be overdone, but ACOs are now established as a different—and confusing—new customer segment for pharma.
      PubDate: Sat, 26 Apr 2014 07:55:02 -040
  • Building Long-Term Value Into Near-Term Commercial Strategy
    • Abstract: Pharma companies are building long-term value propositions that should appeal to Accountable Care Organizations into some go-to-market strategies for new drugs and to repositioning efforts of already marketed drugs that have hit snags. The rationale might seem straightforward—for example, more convenient dosing that improves compliance and cuts down hospitalization rates--but the nuances can be complex.
      PubDate: Sat, 26 Apr 2014 07:50:01 -040
  • Antibiotic Incentive Legislation: Can Reimbursement Horn In'
    • Abstract: There are two antibiotic incentive bills vying for attention in Congress. One is a follow-on to the popular GAIN Act; the other takes a new path – creating generous reimbursement formulas to help the next wave of anti-infectives find a successful niche in hospital market.
      PubDate: Fri, 25 Apr 2014 16:30:01 -040
  • PhRMA 2014: IP, Research, and Reputation
    • Abstract: NIH research support, intellectual property protections, and restoring the drug industry’s image moved up on the list of podium priorities at the PhRMA annual meeting in Washington, DC.
      PubDate: Fri, 25 Apr 2014 12:25:01 -040
  • The Part D Premium Lesson For Exchanges
    • Abstract: Outgoing CMS Principal Deputy Jon Blum called on the Part D experience in trying to discuss the challenges of lowering cost sharing for specialty tier drugs in the exchanges.
      PubDate: Fri, 25 Apr 2014 11:45:01 -040
  • Pfizer’s Unusual Contribution to the Afrezza
    • Abstract: FDA’s portion of the advisory committee review of MannKind’s inhaled insulin included an unusual number of separate presentations (five) – and one especially unusual review based on a slide presentation from the first inhaled insulin sponsor, Pfizer.
      PubDate: Fri, 25 Apr 2014 09:35:25 -040
  • Regulating in an Era of Increasingly Sophisticated Medicines –
           Striking the Balance Between Patient Benefits and Risks
    • Abstract: Commissioner Hamburg’s April 22 keynote during the annual Rx Prescription Drug Abuse Summit in Atlanta, Georgia, came amid controversy over the agency’s decision to approve a long-acting hydrocodone formulation, Zohydro. Hamburg addressed the controversy head-on, but also delivered a lengthy and thorough outline of FDA’s intense work on the issue.
      PubDate: Thu, 24 Apr 2014 16:19:48 -040
  • NIH Official Shows Little Patience For FDA’s Processing of
    • Abstract: The Food & Drug Administration is too slow to incorporate advice from its patient-focused meetings into drug development endpoints. That’s the gentle translation of some recent comments from an NIH senior official.
      PubDate: Mon, 21 Apr 2014 09:20:08 -040
  • Voice of the Patient: Supporting FDA As Well As Educating FDA
    • Abstract: The Food & Drug Administration’s patient-focused meetings are primarily listening sessions for the agency drug reviewers involved. But the FDA participants can go the next step and ask the patients for help with public debates.
      PubDate: Sun, 20 Apr 2014 00:00:00 -040
  • Fat To Water: Big Hopes For Microbiome Approaches To Obesity and Metabolic
    • Abstract: Finding the right microbial balance in the gut may be the way of the future for treatment of conditions like obesity and diabetes. That’s where some notable medical futurists are looking and where some early commercial clinical trials are underway.
      PubDate: Wed, 09 Apr 2014 12:40:00 -040
  • Washington Threatens; Wall Street Reacts
    • Abstract: The biotech investment boom hit the brakes at the end of the first quarter when Rep. Henry Waxman (D-Calif.) publicly complained about Gilead’s pricing for the hepatitis C therapy Sovaldi.
      PubDate: Wed, 09 Apr 2014 11:25:03 -040
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