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Biotech in the Money, May ’10 Edition

  1. Why the Paradigm Shift at the FDA, over the Past 5 Years?
  2. Is Anything Binding With the FDA Anymore, or Are Companies Just Not Listening?
  3. Chronic Disease vs. Critical Needs: the FDA Fast Track, and Recourses for Companies
  4. Biosimilars are Without a Champion at the FDA
  5. FDA Very Actively Enforcing Compliance Regulation
  6. If You Had Unlimited Powers, How Would You Reform the FDA?
  7. Combination Therapy in the Eyes of the FDA. Can We Let FDA Off the Hook? The System Return to a More Rational Process

VICL – Vical CEO Vijay Samant interviewed by Stephen Willey

  1. DNA Vaccines, a Fast and Efficient ‘Plug-N-Play’ Technology
  2. Allovectin-7, a Phase 3 Cancer Immunotherapy for Head & Neck Tumors
  3. TransVax, a Phase 2 DNA Vaccine to Prevent Cytomegalovirus (CMV) Reactivation
  4. Vical’s Speed and Adaptability Play on Pandemic Influenza Appeals to Department of Defense for Military Vaccines
  5. Vical Licensors, Sanofi and Angios, in Phase 3 Trials on Multi-Billion Dollar PAD Market

Biotech in the Money, April ‘10 Edition

  1. Meeting Update: Hepatitis C – 2010 EASL
  2. Meeting Update: Neurology – 2010 AAN
  3. Obama’s Healthcare Reform, Good for Pharma, Biotech, and Generics?
  4. Implications of the MYGN Suit, the Future of Genetic Testing
  5. Status of the Financial Markets, IPOs and FOs in the YTD

Multiple Sclerosis Breakthrough, Dr. Laurence Steinman

  1. New Blood Test Predicts Efficacy of Multiple Sclerosis Drug Beta Interferon
  2. 1-in-4 MS Patients Could Be IL17 Non-Responders to the $4Bn Revenue Beta Interferon Drug
  3. IL17 to Multiple Sclerosis as KRAS to Colon Cancer?
  4. When Will the 300,000+ Patients on Beta Interferon Benefit From Dr Steinman’s Breakthrough Study?
  5. Impact of IL17 on MS Drugs in the Pipeline, and Potential Applicability in PML

Biotech in the Money, March ’10 Edition

  1. The OSIP / Astellas Saga
  2. The 2010 Biotech IPO Review, 1st Quarter
  3. Medivation’s Phase 3 is a Total Bust. Will Dimebon get a Second Life?
  4. Xenoport’s Phase 3, Also a Bust. An Eleventh-hour FDA Decision?
  5. Good News of the Month : Acorda and Viropharma, Stories with Upside
  6. Big Pharma’s Cancer Setbacks, Arrr You Hungry for More Biotech?
  7. Shareholder Activism : What Carl Icahn Can and Cannot Do with Genzyme
  8. Next Month in Biotech, Events to Look Out For
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