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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]
  • “Breakthrough” Means Breaking Down Bureaucracy
    • Abstract: FDA’s Richard Pazdur has the oncology review team at FDA out on the cutting edge of “Breakthrough” reviews. He sees the key elements of making breakthrough work as cutting through layers of traditional processes and setting faster pathways for subsequent drugs.
      PubDate: Mon, 17 Nov 2014 14:30:01 -050
       
  • Ebola Outbreak Draws Investor Attention; Real Impact May Be Clinical Trial
           Models
    • Abstract: The race is on to develop Ebola treatments and vaccines. Investors have noticed.
      PubDate: Mon, 17 Nov 2014 12:05:00 -050
       
  • Ebola Therapies: NIAID’s Perspective
    • Abstract: National Institutes of Allergy & Infections Diseases Director Anthony Fauci provided a comprehensive overview of potential therapeutics and vaccines in the pipeline for Ebola as part of his written testimony for an October 16 hearing. Here are the specific agents cited, along with comments from Fauci and others during the hearing.
      PubDate: Mon, 17 Nov 2014 11:50:01 -050
       
  • Doubling Down On Antibiotic Incentives: Congress, Obama Administration
           Drafting Proposals
    • Abstract: The 2012 FDA Safety & Innovation Act included important new incentives for antibiotic developers. But the Obama Administration and key legislators want to do even more to revive R&D in the space.
      PubDate: Wed, 12 Nov 2014 15:15:07 -050
       
  • CMS Sunshine Data And Ultra-Orphan Relationships: Aegerion May Have More
           Payments Than Patients
    • Abstract: Data from CMS’ Open Payments shows Aegerion may have been making more payments to physicians than it had patients in its ultra-orphan segment of the hypercholesterolemia population.
      PubDate: Mon, 10 Nov 2014 15:55:01 -050
       
  • "Sunshine" Database Picks Up Most Vetted-of-Vetted Doctors: FDA Advisory
           Committee Members
    • Abstract: How broad is the Sunshine payment list? Even the highly vetted members on FDA’s advisory committees show up as recipients of payments from healthcare companies during the last three months of 2013.
      PubDate: Mon, 10 Nov 2014 15:40:00 -050
       
  • Entyvio REMS Decision Explained
    • Abstract: FDA approved Takeda’s Entyvio (vedolizumab) for Crohn’s and ulcerative colitis without a formal Risk Evaluation & Mitigation Strategy. In the review materials, the agency explains its decision.
      PubDate: Mon, 10 Nov 2014 15:20:00 -050
       
  • FDA Aspergillosis Biomarker Qualification Highlights New Drug Development
           Tool Process
    • Abstract: FDA’s new drug development qualification process offers a pathway for outside groups to gain acceptance of specific biomarkers for regulatory purposes. FDA recently used the process to qualify a specific biomarker for a severe fungal infection.
      PubDate: Mon, 10 Nov 2014 14:30:01 -050
       
  • Pfizer Gets Abuse-Deterrent Claim on One Pain Drug, Then Drops Development
           of Another
    • Abstract: Pfizer got its first abuse-deterrent claim for its pain therapy Embeda. But it has also ended an agreement to develop another potential abuse-deterrent pain drug.
      PubDate: Mon, 03 Nov 2014 10:50:01 -050
       
  • CDER Office of Product Quality Raises Manufacturing Profile Within FDA,
           Poses Similar Challenge To Industry
    • Abstract: It took a while, but the Office of Pharmaceutical Quality is finally ready to begin operations. Biopharma companies should recognize the declaration of FDA’s priorities, and respond accordingly.
      PubDate: Thu, 30 Oct 2014 00:00:35 -040
       
  • 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
       
 
 
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