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Understanding the FDA – Biotech In the Money

Biotech In the Money with Marina Bozilenko
  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

Hepatitis C, Neurology, Healthcare Reform, Genetic Testing – Biotech in the Money

Biotech In the Money with Marina Bozilenko
  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

IPO Review, OSIP, Medivation, Xenoport, Genzyme – Biotech in the Money

Biotech In the Money with Marina Bozilenko
  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

An Interview with Steve Burrill

  1. Adapting to Change, an Interview with Steve Burrill
  2. No Real Healthcare Reform, Only Insurance Reform
  3. Financing Biotech in 2010
  4. From Personalized Medicine to Preemptive Medicine
  5. Stem Cells and Other Promising New Technologies
  6. FAST Word Association Game, with Steve Burrill

MYGN – Myriad Genetics CEO Peter Meldrum Interviewed by Charles Duncan

  1. A Brief History of Myriad Genetics
  2. BRAC Analysis, Myriad Genetics’ Primary Revenue Driver
  3. Is a European Expansion to be Expected from Myriad Genetics? Checklist and Roadmap
  4. Optimal Chemotherapy Dosing with OnDose, from Myriad Genetics
  5. Myriad Genetics’ Latest Diagnostic (PROLARIS) Predicts Prostate Cancer Recurrence.
  6. Patenting Genes: What if the ACLU Wins the Case Against Myriad Genetics?
  7. Financials: How is Myriad Genetics Planning to Return Cash to Investors?

Paion AG CEO Wolfgang Soehngen Interviewed by Swati Kumar

  1. Batman is Back, Busting Clots with Desmotoplase
  2. Paion De-Risks Pipeline with Acquisition of New Value Driver CNS 7056
  3. IPaion’s Search & Develop Strategy: Get the Proof of Concept Faster and Cheaper than Pharma

Addex CEO Vincent Mutel Interviewed by Ram Selvaraju

  1. Dim That Receptor Activity with Addex’s Allosteric Modulation
  2. Addex’s New Lead Molecule ADX48621, Expected To Be Partnered Soon?
  3. December 2009, A Major Setback for Addex. Use of Cash, and Other Pipeline Molecules
  4. ADDEX Undervalued? What Could Drive Stock Price In The Next 6 Months

Osteoporosis Breakthrough, Professor Gerard Karsenty

  1. Major Breakthrough in $5bn Osteoporosis Market
  2. Inhibiting Serotonin Synthesis in the Gut, Rationale for Treating Osteoporosis
  3. How Does an Anabolic Treatment Compare to Other Approaches in Development for Osteoporosis?
  4. Study of Rare Genetic Disease Leads to New Target for the Treatment of Most Common Bone Disease
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  • Series

    • The Stem Cell Review

  • Shows

    • Biotech in the Money
    • Wall Street On BBTV
    • Science Breakthrough
    • The Jan Buck Show
    • 60sec Pitches
    • Special Interview
    • Report on Location

  • Acknowlegments

    NASDAQ OMX BIO Nature Medicine William Blair Banc of America Cowen Group JMP Securities JP Morgan Ladenburg Thalmann Lazard Capital Markets Piper Jaffrey
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