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Journal Cover The RPM Report
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     ISSN (Online) 2160-4665
     Published by Informa plc Homepage  [13 journals]
  • Turning the Page on Zohydro' New Formulations,
           New Division Leadership Should Help FDA Move Forward in Opioids
    • Abstract: The long-time head of FDA’s pain drug review group, Bob Rappaport, has retired after 20 years at FDA. The new acting Division Director is Sharon Hertz – suggesting continuity in the substance of reviews, but perhaps a symbolic change in moving beyond the controversy over Zohydro.
      PubDate: Thu, 23 Oct 2014 13:15:03 -040
       
  • A Warm Send-Off For FDA’s Rappaport
    • Abstract: Here is CDER Director Janet Woodcock’s email to staff announcing Rappaport’s departure (dated September 22).
      PubDate: Thu, 23 Oct 2014 11:45:02 -040
       
  • Co-Payer Beware' OIG Report Cites Kickback Concerns With Part D Copay
           Coupons
    • Abstract: An HHS Inspector General report finds that manufacturer safeguards may be inadequate to prevent copay coupon use in Medicare Part D. The finding puts CMS in a tricky position – how to limit any chance that coupons inducing use of high-priced brands without cutting off vital support for needy beneficiaries.
      PubDate: Wed, 15 Oct 2014 11:45:04 -040
       
  • Gilead’s Sovaldi: Shooting Star Instead of
           Blockbuster
    • Abstract: Gilead’s Sovaldi HCV treatment has earned a special place in pharma lore with its rapid rise to about $10 billion in sales (bringing with it lots of controversy about the sustainability of specialty drug pricing). Now the product appears poised to make a new reputation: fastest to fall from blockbuster status.
      PubDate: Wed, 15 Oct 2014 11:40:02 -040
       
  • Biosimilar Policy Update: Extrapolation Looks Like Default Approach
    • Abstract: As FDA nears the first review deadlines for biosimilar applications, some policy points are coming into sharper focus. Clinical studies for immunogenicity sound like a benchmark requirement, while extrapolation of indications also seems like the agency’s default position.
      PubDate: Wed, 15 Oct 2014 00:00:13 -040
       
  • From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age
           At FDA
    • Abstract: An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.
      PubDate: Wed, 15 Oct 2014 00:00:03 -040
       
  • Cure for Alzheimer's Disease: Cost or Value'
    • Abstract: If the societal reaction to the costs to cure Hep C is any indicator, a potential cure for Alzheimer’s will surely stir controversy assuming breakthrough-level pricing. A financing solution may be the only way to reward developers for the value of the therapy and address the challenges facing insurers.
      PubDate: Tue, 14 Oct 2014 15:00:00 -040
       
  • Creating A New FDA/Capitol Hill Legend
    • Abstract: When FDA managers reflect on their experiences on Capitol Hill, the stories often involve unfair, inflammatory or downright abusive sessions. But Center for Drug Evaluation & Research Director Janet Woodcock has built a different legend this year during the 21st Century Cures initiative of the House Energy & Commerce Committee: repeated, unalloyed praise.
      PubDate: Wed, 08 Oct 2014 00:00:10 -040
       
  • A Good Week For Cardiovascular Research Centers
    • Abstract: FDA took regulatory actions related to cardiovascular outcomes trials in obesity, opioid-induced constipation, triglycerides and testosterone. But the number of new studies conducted may actually be smaller than it sounds.
      PubDate: Wed, 08 Oct 2014 00:00:02 -040
       
  • A Patchwork of Patient Assistance in Part D
    • Abstract: The Medicare.gov website has a section on pharmaceutical assistance programs that contains an alphabetical list of drug names that provides details on prescription brand drugs and the criteria for patient assistance. Here are some examples of how manufacturers handle those programs.
      PubDate: Wed, 08 Oct 2014 00:00:00 -040
       
  • FDA Using Medicare Data Linked to NCI Databases to Look at Cancer Signals
    • Abstract: FDA is looking at linking Medicare data to National Cancer Institute registries to enhance the information from medical claims data and gain a better understanding of disease-cancer and drug-cancer relationships. A familiar figure from FDA epidemiological work is keenly involved: safety officer David Graham.
      PubDate: Thu, 02 Oct 2014 13:45:03 -040
       
  • Personalized Medicine Versus The Public Health: FDA Debates The
           “Polypill”
    • Abstract: FDA is beginning to solicit input from the medical community on review issues for a multi-ingredient cardiovascular product designed to control hypertension, platelet aggregation and cholesterol levels. The key issue is whether convenience and broad access make up for loss of individualized dosing.
      PubDate: Wed, 01 Oct 2014 00:00:01 -040
       
  • FDA “JumpStart” Data Service Gives Reviewers Leg Up On Complex
           NDAs
    • Abstract: FDA is looking for ways to make the review process more efficient, especially as biopharma applications become more data-heavy and complex. One new time-saving review tool at FDA, JumpStart, “partitions” the work on an NDA or BLA by asking data experts in the Office of Computational Science to run initial analyses and flag areas for follow up by the review teams.
      PubDate: Mon, 22 Sep 2014 12:50:02 -040
       
  • To Curb Medical Costs, Let Market Forces Do Their Job
    • Abstract: Competition and a focus on effectiveness rather than price will lower America’s healthcare bill.
      PubDate: Sun, 21 Sep 2014 00:00:01 -040
       
  • Another “Biosimilar” Milestone: FDA Tentatively Approves
           Lilly/BI Copy Of Lantus
    • Abstract: It isn’t a 351K pathway drug, but it does set up an interesting comparison for sponsors using the formal biosimilar pathway compared to the 505(b)(2) NDA route.
      PubDate: Thu, 18 Sep 2014 09:44:51 -040
       
  • Too Many Combos' FDA Reflects On Antihypertensive Approval Standards
    • Abstract: In an unusually long preface to the questions posed to the Cardiovascular & Renal Drugs Advisory Committee on September 9, FDA reflects on the value of the ever-expanding roster of antihypertensive combination therapies. The meeting ended with a vote against Actavis/Forest Labs’ proposed nebivolol/valsartan combo.
      PubDate: Mon, 15 Sep 2014 15:00:01 -040
       
  • Time For LUFA' Lab-Developed Test Policy Will Be Key Piece Of 2017 FDA
           Law
    • Abstract: FDA is hoping to set up yet another user fee program—this one for lab-developed test oversight—when the next user fee legislation is enacted in 2017. The labs aren’t ready to negotiate yet, but the issue is going to be an important area for biopharma to monitor as the transition to personalized medicine continues.
      PubDate: Sun, 14 Sep 2014 00:00:00 -040
       
  • Voice of the Patient: Peer “Ambassadors” Help Recruitment at
           Aegerion
    • Abstract: In the ultra-orphan, ultra-priced segment where the recruitment of each patient is a major commercial event, the voice of existing patients can be very important.
      PubDate: Fri, 12 Sep 2014 10:50:12 -040
       
  • Getting Organized on Abuse-Deterrent Opioids: FDA Calls For Volunteers
           Ahead of Oct. 30-31 Meeting
    • Abstract: FDA is planning a two-day workshop on issues related to abuse-deterrent opioid formulations, and wants to hear unified presentations from the brand and generic industry. That is easier said than done.
      PubDate: Thu, 11 Sep 2014 15:25:00 -040
       
  • PCSK9 Meets PRV: Regeneron’s $70 Mil. Bid To Catch Up To Amgen
    • Abstract: Regeneron and its partner Sanofi have become the first biopharma companies to buy a Priority Review Voucher. The $67 million price is a nice bonus for the seller, BioMarin, but probably not the start of a big new market for PRVs.
      PubDate: Thu, 04 Sep 2014 09:10:00 -040
       
  • ACA Expansion Means Faster Projected Prescription Drug Spending Growth in
           2014-2015
    • Abstract: CMS’s National Health Expenditures Projection team is predicting growth of 6.8 percent in 2014 and 6.4 percent 2015, thanks in large part to the ACA expansions.
      PubDate: Wed, 03 Sep 2014 18:02:00 -040
       
  • Merck Suvorexant Scheduled, But DEA Delays Remain an Issue
    • Abstract: DEA scheduled Merck’s Belsomra (suvorexant) August 28, only two weeks after its August 13 approval – much faster than the year-long wait for some drugs. But don’t take that to mean that the DEA process is moving faster for new drugs.
      PubDate: Fri, 29 Aug 2014 11:40:00 -040
       
  • Naloxone Behind-the-Counter' Petition Could Help Push Action
    • Abstract: The idea of “behind-the-counter” may be behind the times, but a request to put naloxone there could help push FDA’s existing interest in expanding access to the overdose antidote.
      PubDate: Fri, 29 Aug 2014 09:50:00 -040
       
  • Tax Inversions and Price Attacks: Will Wyden Make the Link'
    • Abstract: Finance Committee Chair Ron Wyden is promising immediate action to stop the trend of biopharma companies acquiring ex-US firms to reincorporate for tax reasons. The prospects for legislation are limited – but will the debate open up a new angle to attack biopharma pricing in the US?
      PubDate: Wed, 20 Aug 2014 14:45:00 -040
       
  • Biosimilar Naming Decision Nears as Applications Arrive At FDA
    • Abstract: Several recent events have ratcheted up the pressure on the Obama Administration to offer some finality on the ongoing naming debate for biosimilars.
      PubDate: Mon, 18 Aug 2014 11:45:00 -040
       
 
 
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