BioMed Stock Movers: DNDN, EXAS, KG Print E-mail
Wednesday, 08 April 2009 10:26
Dendreon (DNDN) has stalled out around $6.50 per share after a major rally on news of upcoming presentation at a medical conference later this month. DNDN expects to report Provenge clinical trial results some time before the end of April, although it did not guarantee this would occur at the upcoming presentation. The recent spike in shares of DNDN and upcoming presentation do not provide any clarity on whether Provenge results will be sufficient for attaining FDA approval and the pending data release will determine the Company's fate.
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FDA, Clinical Trial Calendar Updates: SOMX, EPIX, HLUKY, ARKTF Print E-mail
Tuesday, 07 April 2009 18:37
Below is a summary of updates to the BioMedReports.com database of 239 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 113 entries through 4/7/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. 
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FDA, Clinical Trial Calendar Updates: THRX, GILD, TEVA, ALNY, RNUGF Print E-mail
Monday, 06 April 2009 18:17
Below is a summary of updates to the BioMedReports.com database of 239 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.  The Clinical Trial Calendar includes 127 entries through 4/6/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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FDA Calendar Updates: SNTS, CEPH, AZN, DNDN, GILD, NVO Print E-mail
Monday, 06 April 2009 13:42
Below is a summary of updates to the BioMedReports.com database of 239 entries included in the FDA and Clinical Trial Calendars. You can also follow me on Twitter at http://twitter.com/mikehavrilla The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.  
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Lixte Biotech: Shifting Focus to Cancer Drug Discovery Print E-mail
Friday, 03 April 2009 08:23
Lixte Biotechnology (LIXT.OB) was founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to become a cancer drug discovery operation. Lixte engages in the discovery of anti-cancer compounds to improve the treatment of malignancies with few effective treatment options, such as certain types of brain cancer. Other areas of early-stage, preclinical drug discovery include: (1) improved anti-fungal treatments for patients with compromised immunity (e.g. HIV/AIDS, bone marrow transplantation); (2) neurodegenerative conditions such as Alzheimer's and Parkinson's disease; and (3) biomarker assays for diagnostic and prognostic applications in the detection of disease and monitoring of treatment effectiveness.
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A Resurgence in Cell Therapeutics Print E-mail
Thursday, 02 April 2009 14:26
Since I profiled Cell Therapeutics (CTIC) two months ago as a cancer biotech that was down, but not out; the stock price has more than quadrupled from 8 cents to 36 cents during intraday trading today. CTIC continues to reduce operating expenses and sold its remaining stake in a joint venture to market cancer drug Zevalin to Spectrum Pharma (SPPI) for $16.5M last month (in addition to receiving $15M last December from SPPI for the initial 50% stake). CTIC reduced operating expenses in 2008 by 33% and provided guidance which included a forecast of slashing net operating expenses by about 50% during 2009. The Company expects to complete its pixantrone NDA submission during 2Q09 with a six-month priority review request (for potential approval during 2009) since reporting positive Phase 3 results in patients with relapsed, aggressive non-Hodgkin's lymphoma.
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ImmunoCellular Therapeutics: Targeting Cancer Stem Cells Print E-mail
Wednesday, 01 April 2009 16:29
ImmunoCellular Therapeutics (IMUC.OB) is developing cellular immunotherapies for the treatment of brain cancer and monoclonal antibodies to diagnose and treat several different cancers. The Company is developing a stem cell cancer vaccine (ICT-121) which targets a protein marker called CD133 which is typically expressed only on cancer stem cells and not on normal cells. Cancer stem cells ("CSC") are responsible for the prolific growth of primary and metastatic tumors and these cells must be eliminated for the complete eradication of a tumor. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which could be used to target CSCs.
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FDA, Clinical Trial Calendar Updates: Weight Loss, Diabetes, and More Print E-mail
Wednesday, 01 April 2009 14:56
Below is a summary of updates to the BioMedReports.com database of 246 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 110 entries through 4/1/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.  
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Unilife: Making Syringes Safer, Relocating to U.S. Print E-mail
Tuesday, 31 March 2009 03:55
For the first time since its public listing in 2002, Unilife Medical Solutions (Australia: UNI.AX) (U.S. ADR: UNIFF.PK) posted a net profit which came in at $11M for the six-month period ending 12/31/08. Unilife posted a 43% increase in revenue to $2.7M, compared to the year-ago period and net income was driven by $23.4M in other income (largely accounted for by a major licensing deal for the Company's pre-filled syringe). The Company ended the year with $10.9M in cash/equivalents and total liabilities of $7.4M ($3.2M current, $4.2M long-term). Unilife has manufacturing subsidiaries registered with the FDA in China and near Harrisburg, PA. The Company and its subsidiaries include about 70 staff across the U.S., China, and Australia. Unilife is ISO 13485:2003 certified, which means that the Company meets the requirements for providing medical devices and related services that consistently meet customer requirements and regulatory (FDA) requirements.
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Rockwell Medical: Improving Margins, SFP Key to Future Print E-mail
Wednesday, 25 March 2009 15:56
In mid-March, Rockwell Medical Technologies (RMTI) reported 4Q and FY08 results which included revenue of $13.5M (up 13.3% from year-ago quarter) and $51.6M (up 20% compared to 2007). The net losses were ($3M) and ($7.9M) for 4Q and FY08, respectively. Despite solid sales growth, RMTI has posted losses as margins have suffered due to higher raw material/fuel costs and other investments in personnel, information technology (IT), and clinical development costs for its water soluble iron replacement therapy for dialysis patients called SFP for short (Soluble Ferric Pyrophosphate).
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