Domain Invest

  • Subscribe to our RSS feed.
  • Twitter
  • StumbleUpon
  • Reddit
  • Facebook
  • Digg

Thursday, 6 September 2007

The Cost of FDA's Credibility Gap

Posted on 01:20 by Unknown
In previous posts, I have talked about the rising challenges facing the pharmaceutical and biotech industries stemming from FDA's credibility gap. In fact, I think FDA's credibility gap is one of the most pressing business problems for biopharma companies right now and for the foreseeable future.

I want to point you to a story I just wrote, hot off the Internet's virtual presses. The story, "Avandia and the Commercial Impact of FDA's Credibility Gap" can be found on our new website http://rpmreport.com/. Just register for the free trial, and you can read that, and many other stories we've written for our September issue.

Some of the takeaways from the story are:

1) FDA's credibility is one of the top commercial challenges facing biopharma decision makers.

2) Business leaders are re-thinking their drug development programs as a result of the current environment.

3) The FDA advisory committee on Avandia did more to hurt than help FDA's credibility crisis.

4) FDA is grappling with how to manage incoming information faster and more effectively.

Registration is easy, so go take a look. I'd love to hear thoughts from the investment community about this issue. Also, tell us what you think of the http://rpmreport.com website.
Email ThisBlogThis!Share to XShare to Facebook
Posted in Avandia, FDA, shameless self-promotion, The RPM Report | No comments
Newer Post Older Post Home

0 comments:

Post a Comment

Subscribe to: Post Comments (Atom)

Popular Posts

  • Take the Money…or Let it Roll?
    In his talk introducing the top-10 most licensable oncology drugs at the Therapeutic Alliances conference last Friday, Ben Bonifant of Campb...
  • $80 million upfront? About Average
    So Synta’s PR firm were pushing today’s deal with GlaxoSmithKline at us as “one of the biggest product deals this year” and indeed “among t...
  • Beijing Boost for Japanese Encephalitis Vaccine
    China has been preparing feverishly for the Beijing Olympics for years to showcase its new world position and economic power. China's co...
  • Reporting on Exubera: an A-Buse
    Many analysts have questioned the potential of Pfizer’s inhaled insulin, Exubera . Nonetheless, it was more than surprising to see the comme...
  • The Best Defense Is a Good Offense, Or Something Like That
    Merck and Schering-Plough put out a release a few minutes ago responding to critics of ENHANCE and the trial results' fallout: WHITEHOU...
  • Public Confidence in Drug Safety: Solution is in "Plane" Sight
    Active surveillance and data mining are scary, right? It is common wisdom that these tools in the hands of academics, health plans and regul...
  • Addex Ups Dealmaking Ante
    Addex Pharma today took a step up the dealmaking ladder , partnering its pre-IND positive allosteric modulator ADX63365 and back-up compound...
  • Pfizer UK Gets “Closer to Customers”
    “Increased patient safety” drove Pfizer’s recent deal with UK wholesaler Alliance UniChem, according to the partners. But no one’s buying th...
  • Another Look at Asia
    As a small follow up to our post last week on Sofinnova Partners' hiring an Asia-focused professional, VentureWire Lifescience reported...
  • Deals of the Week: "King of Pain" Edition
    Admittedly, it's been a quiet week for biz dev in pharma land. The big news has been clinical. On the positive side, the diabetes triumv...

Categories

  • Abbott
  • activist shareholders
  • ADHD
  • advisory committees
  • alliances
  • Alnylam
  • Alzheimer's disease
  • Amgen
  • Andrew von Eschenbach
  • Andrew Witty
  • Astellas
  • AstraZeneca
  • Avandia
  • Avastin
  • Barack Obama
  • Barr
  • Bayer
  • Big Pharma
  • BIO
  • Biogen Idec
  • biologics
  • biosimilars
  • blogging
  • BMS
  • Boston Scientific
  • brand names
  • business development
  • business models
  • cancer vaccines
  • Carl Icahn
  • CBO
  • CDER
  • Celgene
  • Cephalon
  • China
  • clinical development
  • CMS
  • co-promotes
  • comparative effectiveness
  • conference
  • Congress
  • consumer genomics
  • corporate culture
  • corporate governance
  • corporate venture capital
  • CVS Caremark
  • Cytyc
  • David Kessler
  • deals of the week
  • debt financing
  • Diabetes
  • diagnostics
  • Dick Clark
  • drug approvals
  • drug delivery
  • drug discovery
  • drug eluting stents
  • Drug Pricing
  • drug safety
  • drug samples
  • DTC Advertising
  • e-health
  • Eisai
  • Elan
  • Eli Lilly
  • Emphasys
  • emphysema
  • Endo
  • epo
  • Euro-Biotech Forum
  • Exits
  • Exubera
  • FDA
  • FDA/CMS Summit
  • FDAAA
  • Film and TV
  • financing
  • FOBs
  • Forest Labs
  • Galvus
  • gene therapy
  • Genentech
  • General Electric
  • generics
  • Genzyme
  • Gleevec
  • Google
  • GSK
  • Guidant
  • haircuts
  • Happy Holidays
  • HCV
  • Headhunting
  • Health Care Reform
  • hedge funds
  • Henry Waxman
  • hGH
  • HHS
  • Hillary Clinton
  • Hologic
  • hostile takeovers
  • hypertension
  • ImClone
  • IMS Health
  • In vitro diagnostics
  • In3
  • India
  • insomnia
  • instrumentation
  • insulin
  • Inverness
  • IP
  • IPO
  • IPO pricing
  • Isis Pharmaceuticals
  • Israel
  • IT
  • JAMA
  • Januvia
  • Japan
  • John McCain
  • Johnson and Johnson
  • JP Morgan
  • LaMattina
  • lawsuits
  • layoffs
  • legislation
  • Life-Cycle Management
  • Lipitor
  • Lucentis
  • management succession
  • Mark McClellan
  • marketing
  • Martin Mackay
  • medical devices
  • Medicare
  • Medicare Part D
  • Medimmune
  • Medtech Insight
  • Medtronic
  • Merck
  • Merck-Serono
  • mergers and acquisitions
  • Michael McCaughan
  • Millennium
  • mmm beer
  • MRI
  • multiple sclerosis
  • music
  • nanotechnology
  • NEJM
  • new drug approvals
  • new funds
  • NICE
  • NicOx
  • NIH
  • Nobel Prize
  • Novartis
  • Novo Nordisk
  • Nycomed
  • off-label promotion
  • oncology
  • ophthalmology
  • Orthopedics
  • osteoporosis
  • OTC drugs
  • Out-Partnering
  • Oxycontin
  • pain
  • Part D
  • Patient Advocacy
  • PDUFA
  • personalized medicine
  • Pfizer
  • pharmacy benefits
  • PhRMA
  • politics
  • poll results
  • PR
  • prasugrel
  • Presidential Election
  • Press Release of the Week
  • Primary Care
  • private equity
  • Procter and Gamble
  • PSA
  • Purdue Pharma
  • rare diseases
  • reimbursement
  • research and development productivity
  • research and development strategies
  • reverse mergers
  • rimonabant
  • RiskMAP
  • RNAi
  • Roche
  • Roger Longman
  • royalties
  • sales forces
  • Sanofi-aventis
  • Schering-Plough
  • Science Matters
  • Sepracor
  • shameless self-promotion
  • share buybacks
  • Shire
  • Sirtris
  • Smith and Nephew
  • Solvay
  • SPACs
  • spec pharma
  • spin-outs
  • sports
  • Start-Up
  • statins
  • Steve Nissen
  • Stryker
  • Supreme Court
  • Takeda
  • Teva
  • Thanksgiving
  • The RPM Report
  • UCB
  • vaccines
  • Velcade
  • Ventana
  • venture capital
  • venture debt
  • Venture Round
  • Vertex
  • Vioxx
  • Vytorin
  • Wacky World of Generics
  • While You Were ...
  • Wyeth
  • Zetia
  • Zimmer
  • ZymoGenetics

Blog Archive

  • ►  2008 (76)
    • ►  February (25)
    • ►  January (51)
  • ▼  2007 (329)
    • ►  December (32)
    • ►  November (42)
    • ►  October (37)
    • ▼  September (33)
      • Co-promotes: No Longer Biotech’s Holy Grail
      • Ortho Settlement Doesn't Settle Everything
      • Another Look at Asia
      • What About Specialty?
      • PSA Day 2: Buying into Biologics
      • Smaller Big Pharma and the Hybrid Future
      • How to Improve Drug Development? Fail Fast!
      • Merck: Embracing Externalization, From the Top Down
      • IPOs: Just Another Facet of the M&A Auction
      • Can't Keep Quiet About This
      • While You Were Packing for New York
      • Strange Bedfellows: Novartis Marries VC & Business...
      • Going, Going.....Google
      • The Right Kind of FDA Defense
      • Shire's Portfolio Solution
      • FDARA: Changing Drug Development in the Guise of S...
      • Sofinnova Partners Talks China
      • The Next Big Thing...
      • Can a Sleep Drug Awaken Demand from European Consu...
      • A New VC On The Block. Finally!
      • While You Were in Italy
      • EPO’s Future Back in FDA’s Hands
      • Third Rock Ready To Roll
      • More Bad News Coming on Avandia
      • Who's Sorry Now? Big Pharma Edition
      • Big Pharma: Beware the Coupon Clippers
      • While You Were Finally Watching Some Football
      • Buyer’s Remorse: No Love for Medicare Part D on th...
      • Why Financiers Like Virtual Companies
      • The Cost of FDA's Credibility Gap
      • EPO Fatigue: Amgen Hopes History Doesn’t Repeat It...
      • Science Matters: A small personalized medicine bai...
      • While You Weren't Working
    • ►  August (29)
    • ►  July (39)
    • ►  June (39)
    • ►  May (43)
    • ►  April (16)
    • ►  March (13)
    • ►  February (5)
    • ►  January (1)
  • ►  2006 (8)
    • ►  December (3)
    • ►  November (5)
Powered by Blogger.

About Me

Unknown
View my complete profile