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Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
My company:
ProActive HavRx BioFund
My blog:
BioMedReports.com FDA Calendar
My book:
ProActive HavRx Stock Indexes
  • BioMed Updates Dec 6-8
     
    $PIP $EBS / Pharmathene and Emergent BioSolutions Drop on BioDefense Disappointments / bit.ly/6M6y5V
    21 minutes ago from SeekingAlpha
     
    $GILD / Gilead Sciences / FDA Questions Clinical Studies for Cayston (aztreonam inhaled sol) ahead 10-Dec Panel Mtg bit.ly/6w7irK
    about 1 hour ago from SeekingAlpha
     
    $NEOP.OB / Neoprobe completes Phase 3 Lymphoseek trial / Expects to file NDA with FDA in 2010 / bit.ly/51ZSaH
    about 2 hours ago from SeekingAlpha
     
    $TEVA $WPI $MYL / Teva Pharma Leads Bidders (€2.5-3B) for Private Generic Drug Maker Ratiopharm (Bloomberg source) / bit.ly/5ZLrUS
    about 4 hours ago from SeekingAlpha
     
    BioMedReports.com Revamped Global Healthcare Stock Indexes / bit.ly/5ZLrUS
    about 6 hours ago from SeekingAlpha
     
    $BPAX / BioSante Monetizes US Elestrin Royalty Stream / up to $3.2M cash $140M potential milestones / biomedreports.com
    about 6 hours ago from SeekingAlpha
     
    $QDHC / QuadraMed Acquired by PE firm Francisco Partners at 32.6% premium / biomedreports.com
    about 7 hours ago from SeekingAlpha
     
    $CLDX / Celldex CDX-011 Poster Presentation on 12/13/09 for Metastatic Breast Cancer Phase I/II Study biomedreports.com
    1:02 PM Dec 7th from SeekingAlpha
     
    $BAYRY.PK $JNJ / Bayer JNJ Xarelto FDA Resubmission Delayed / Bayer will provide update on strategy 2/28/10 / biomedreports.com
    12:53 PM Dec 7th from SeekingAlpha
     
    $AMGN / Amgen Expands Stock Repurchase Program $5B / Presented Nplate data ASH / biomedreports.com
    10:11 AM Dec 7th from SeekingAlpha
     
    $IMUC.OB / ImmunoCellular / $10M Financing Commitment to Dev Cancer Stem Cell Vaccines thru 2011 / Pref Stk, Wrnts biomedreports.com
    10:07 AM Dec 7th from SeekingAlpha
     
    $CELG $ALTH / Celgene Acquires Gloucester / Istodax Ongoing Trial for PTCL to compete with Allos (Folotyn) / biomedreports.com
    9:42 AM Dec 7th from SeekingAlpha
     
    $SOMX / Somaxon Pharma Down 65% Pre-Mkt / FDA Issues CRL for Silenor (doxepin) insomnia NDA / biomedreports.com
    9:20 AM Dec 7th from SeekingAlpha
     
    $CYTX / Cytori / Interim Data 12-Dec / 32 Patients 6-Month F/U Breast Reconstruction / Fat-Derived Adult Stem Cells / bit.ly/51ZSaH
     
    Disclosure: Long BPAX, CLDX, CYTX, IMUC.OB
    Dec 08 04:19 pm | Link | Comment!
  • BioMedReports.com Healthcare Stock Indexes
    The Cosmetic / Restorative Medicine Index tracks the performance of companies that derive over 50% of revenue from any of the following activities: (1) prescription skin care therapeutics; (2) medical devices, products, services, OR equipment for procedures which are intended to enhance appearance; (3) medical devices, products, services, OR equipment for use as joint replacements, tissue repair agents, tissue reconstruction agents, surgical adhesives, and cardiovascular procedures; and (4) regenerative medicine products, services, and/or an active clinical pipeline which seeks to restore or repair the functionality of lost or damaged organ, tissue, cellular, and genetic material.
    View Listings
     
    Diabetes Care (39) Company(s)
    The Diabetes Care Index tracks the performance of companies which derive the majority of revenue from diabetes care products, have double-digit market share for any type of diabetes care market, and / or have a diabetes care product in development.
    View Listings
     
    Emerging Cancer Dx / Tx (75) Company(s)
    The Emerging Cancer Dx / Tx (Diagnostic / Therapeutic) Index tracks the performance of a cross-section of oncology companies with market caps below $500 million at the time of index inclusion, encompassing the following categories: (1) diagnostics (molecular diagnostics and device-based diagnostics), (2) lab services (personalized medicine applications to guide and track the effectiveness of cancer treatments), (3) drug discovery (screening and modifying compounds to achieve anti-cancer effects during the early stages of preclinical and Phase 1 clinical studies), (4) immunotherapy (a.k.a. cancer vaccines which are designed to stimulate the immune system to eradicate cancer), and (5) commercial or late-stage (Phase 2-3) clinical development therapeutics, devices, or diagnostics intended for use by cancer patients.
    View Listings
     
    Generic Drugs (67) Company(s)
    The Global Generic Drug Index tracks the performance of companies which meet any of the following three requirements: (1) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenues from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services for drug products and biological agents; (2) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; (3) As an alternative to the revenue requirement, companies may also qualify by receiving FDA approval for an abbreviated new drug application (ANDA) within the past 12 months.
    View Listings
     
    Health Benefit Providers (45) Company(s)
    The Health Benefit Providers Index tracks the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers.
    View Listings
     
    Health IT (65) Company(s)
    The Global Health IT (Information Technology) Index tracks the performance of companies with market caps below $10 billion that derive over either $50 million or 50% of their trailing 12-month revenue from products and services for the following activities: (1) electronic transmission, storage, and processing of prescriptions; (2) secure e-mail transmission for healthcare facilities; (3) electronic transmission, storage, and processing of medical imaging and diagnostic information; (4) electronic storage and systems for administrative functions of healthcare facilities and medical records; (5) electronic transmission, storage, and systems for healthcare market data and clinical trial data; (6) electronic systems, devices, and services for remote, real-time monitoring of patient health parameters; (7) medical transcription services, products, and systems for conversion into electronic medical records.
    View Listings
     
    Hospitals (31) Company(s)
    The Global Hospital Index tracks the performance of companies which derive over 50% of revenue from the following activities: hospitals, inpatient rehabilitation facilities, dialysis facilities, hospice providers, inpatient behavioral healthcare facilities, and ambulatory surgery centers. The revenue requirement for this index excludes the following activities: home healthcare, outpatient medical services, and senior living centers.
    View Listings
     
    ImmunoTherapy / Vaccines (47) Company(s)
    The ImmunoTherapy / Vaccines Index includes companies with market caps below $5 billion at the time of index inclusion which are developing or commercializing any type of immunotherapy, gene therapy, or vaccine product that is designed to stimulate the immune system for the eradication, combination treatment, or prevention of cancer. In addition, the index will track companies which are developing or commercializing any type of vaccine product or vaccine adjuvant for all types of infectious disease such as influenza (flu) and bio-defense applications.
    View Listings
     
    Life Science Leaders (25) Company(s)
    The Life Science Leaders Index tracks the performance of companies with market caps of at least $20 billion at the time of inclusion that derive the majority of revenue from any type of healthcare product or service, medical device / diagnostic, drug / biological agent, and agri-biotech (crop science and seeds).
    View Listings
     
    Nutraceuticals (46) Company(s)
    The Nutraceuticals Index tracks the performance of companies that manufacture, distribute, or sell any type of non-prescription, over-the-counter (OTC) vitamin / mineral product, herbal / natural remedy, functional food, or other type of health supplement / enhancement product.
    View Listings
     
    Pet Care / Animal Farma (35) Company(s)
    The Pet Care / Animal Farma Index tracks the performance of companies with market caps below $5 billion at the time of inclusion that are active in the following business segments: animal breeding, animal `pharming`, veterinary stem cells, veterinary services, pet retailers, animal feeds nutrition, and veterinary medicine diagnostics.
    View Listings
     
    Stem Cells (49) Company(s)
    The Global Stem Cell Index tracks the performance of regenerative medicine companies which derive over 50% of revenue or have compound(s) in active pre-clinical or clinical development which are designed to restore, replace, repair, or enhance the functionality or appearance of tissue and organ systems, including all types of embryonic and adult stem cell therapeutics. In addition, all types of products and services for stem cell banking are included in this index.
    Dec 08 03:59 pm | Link | Comment!
  • BioMed Updates: ELTP.OB, SOMX, STEM, GERN, ASTM, VRTX, CYTR, IMUC.OB, JAV
    Below is a summary of BioMed updates from 2-Dec, summarized in 140 characters or less each.
     
    $ELTP.OB / Elite Pharma soars 40% on FDA generic approval opiate pain drug methadone along with ThePharmaNetwork
     
    $JAV / Javelin Pharma files NDA for FDA approval of Dyloject (diclofenac injection) (already approved in Europe)
     
    $SOMX / Somaxon Pharma Awaits FDA Decision (expected 4-Dec) for insomnia drug Silenor (doxepin)
     
    $STEM $GERN $ASTM / HavRx Global Stem Cell Index Up on New Tax-Paid Cell Lines / http://bit.ly/4J83Wi
     
    $VRTX / Vertex Pharma Announces Proposed Public Offering AH, Down 2.5% / 10M shares stock / 1.5M options
     
    New Report on Protox by Dundee Securites Ahead of Key Results (TSX: PRX.TO) (OTC: PTXRF.PK) / http://hub.tm/?kGFaK
     
    $CYTR / CytRx / FDA Lifts Clinical Hold / Will resume clinial trial for arimoclomol in ALS patients
     
    $IMUC.OB / ImmunoCellular Notches Deal with MD Anderson for New Cancer Stem Cell Vaccine Target / http://hub.tm/QOmte
     
    Click here to follow me on twitter / mikehavrilla and check out the BioMedReports.com FDA Calendar service, which includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter resubmissions to the FDA; and (4) pending clinical trial results.
     
    Disclosure: Long IMUC.OB, PTXRF.PK
    Dec 02 06:57 pm | Link | Comment!
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