FDA, Clinical Trial Updates: NASDAQ:GTXI, NASDAQ:XNPT, NYSE:GSK, NASDAQ:RMTI Print E-mail
Tuesday, 28 April 2009 04:06
Below is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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.GTx Inc. (NASDAQ:GTXI): Over the weekend, GTXI presented additional Phase 3 data analyzing placebo group data from a study of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT) that revealed nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. During the two year trial, 9.9% of these men had a non-traumatic fracture while 23.9% experienced either a non-traumatic fracture or bone loss of more than 7%.
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Hemispherx Biopharma (AMEX: HEB) and other antiviral drugmakers rocket on news of swine flu virus Print E-mail
By M.E.Garza   
Monday, 27 April 2009 11:13
Shares of niche makers of antiviral products and vaccines saw shares rocket in early trading Monday on news that the world could be facing a global pandemic of the swine flu virus. Concerns about the growing health crisis helped boost drug stocks for Biota Holdings Ltd. (BTAHY)(BTAHF), with U.S.-traded shares shooting up over 600% to $4.40. Australia-based Biota receives royalties on a leading flu-fighting agent, Relenza, which is marketed by GlaxoSmithKline PLC. (GSK) Also gaining at least 40% were Generex Biotechnology Corp. (GNBT), BioCryst Pharmaceuticals (BCRX), Novavax Inc. (NVAX) and Hemispherx Biopharma Inc (HEB). Hemispherx Biopharma had additional good news for its share holders when it announced it had received notice of an Annual Report prepared by a Director of the National Institute of Infectious Diseases to the governing organization of the Japanese Ministry of Health reporting a series of successful preclinical studies in new pandemic vaccines which rely critically on Ampligen an experimental therapeutic for efficacy.
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Allos Therapeutics: Small-Cap Cancer Biotech with FDA Catalyst Print E-mail
Monday, 27 April 2009 04:05
Allos Therapeutics (ALTH) is small-cap cancer biotech which filed a NDA on 3/25/09 for pralatrexate (PDX) in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review for the application, with an expected 60-day period for the FDA to accept the filing and rule on priority review status. The priority review PDUFA date would be 9/25/09 (versus 1/25/10 for standard, 10-month review). PTCL comprises a biologically diverse group of blood-based cancers that typically have a worse prognosis than other types of lymphoma and are less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
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FDA, Clinical Trial Updates: Pro-Pharma (OTC:PRWP) Looks Promising Print E-mail
Friday, 24 April 2009 18:13
Pro PharmaBelow is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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 - Diabetes: AZN, BMY, NVO, Takeda Print E-mail
Thursday, 23 April 2009 07:21
Below is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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, Clinical Trial Calendar Updates: Acorda, Alkermes, GTx Print E-mail
Thursday, 23 April 2009 05:33
Below is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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. 1.) Akermes (ALKS): Earlier this week, ALKS announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.
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BioMed Stock Movers: BDSI, CTIC Print E-mail
Wednesday, 22 April 2009 09:52
Shares of Cell Therapeutics (CTIC) are surging today, trading up by about 40% on nearly 20 million shares in early morning trading on no official news releases. Below is a link to my article coverage for CTIC at BioMedReports.com:http://biomedreports.com/component/search/ctic.html?ordering=&searchphrase=allBioDelivery Sciences (BDSI) has gained nearly 25% in the past five days as the decision date nears for pain drug candidate Onsolis at the FDA. Below is my article coverage of BDSI at BioMedReports.com:http://biomedreports.com/component/search/bdsi.html?ordering=&searchphrase=allDisclosure: No positions
 
FDA, Clinical Trial Calendar Updates: Genzyme, Isis, Osiris, Roche, Watson Print E-mail
Wednesday, 22 April 2009 09:18
Below is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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.1.) Roche (OTC:RHHBY): Highly anticipated clinical trial results for Avastin missed their main goal of preventing the recurrence of colon cancer in patients who have undergone surgery for tumor removal. Shares of Roche in Europe (VTX:ROG) are down by 9% today, representing a loss in market value of about $10B (all currency amounts reflect U.S. Dollars in this article).
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FDA, Clinical Trial Calendar Updates: CTIC, CYPB, DNDN, FRX, MRK Print E-mail
Tuesday, 21 April 2009 05:15
Below is a summary of updates to the BioMedReports.com database of over 200 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 decision deadline dates while the Clinical Trial Calendar 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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Impax Labs: Strong Balance Sheet, Focused R&D Print E-mail
Monday, 20 April 2009 18:41
Impax Labs (IPXL) is a small-cap specialty pharma which includes a generic drug division under the Global Pharmaceuticals label and a branded division with R&D operations under the Impax Pharmaceuticals name. The Company recently re-listed on the Nasdaq after previously trading on the pink sheets so many investors are unaware of IPXL and its excellent growth prospects as a smaller version of Teva Pharma (TEVA) with a mix of generic and branded product divisions.Impax differentiates itself in the commoditized generic drug space through carefully chosen opportunities with minimal competition (i.e. first-to-file and
first-to-market opportunities) by leveraging its expertise and

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technology in the production of controlled release medications, which also applies to the brand division. The Company employs a total of 183 R&D experts (who have a track record of 53 approved ANDAs and 17 NDAs), divided between the generic (137) and brand (46) product divisions.
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