[MOL] Veru Important for all Molers and their cancers;;;;; [01407] Medicine On Line

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[MOL] Veru Important for all Molers and their cancers;;;;;

Here comes generic paclitaxel...
Ivax of Miami expects to begin shipping generic paclitaxel in about three
weeks. A federal judge in San Francisco cleared the last legal hurdle for
the company on Sept. 13 by ordering Bristol-Myers Squibb to de-list a
patent related to its Taxol. Final FDA approval came two days later.
The company says the drug will be about 30% less expensive than brand-name
And another in six months
Mylan Pharmaceuticals of Pittsburgh received tentative FDA approval this
week for generic paclitaxel. The approval is only for the smallest vial
size (20 mg/5 ml), which Mylan says is 15% of the paclitaxel market. Final
 approval, however, will not be granted until 180 days after Ivax begins
marketing the same drug. Ivax, the first to file the generic NDA, is
entitled to 180 days of exclusivity.
MDS agent wins orphan-drug status
SangStat of Fremont, Calif., has received orphan-drug status from the FDA
for Thymoglobulin (antithymocyte globulin) for myelodysplastic syndrome.
The agent, already approved to prevent kidney-transplant rejection, is an
antithymocyte rabbit immunoglobulin that suppresses immunity.
Phase-1 for B-cell lymphoma agent
Berlex Laboratories of Montville, N.J., is beginning phase-1 trials of
Oncolym (I-131-labeled Lym-1 antibody), a MAB for relapsed and refractory
B-cell lymphoma. According to the company, there are no approved
treatments for these patients.
New indication for Bexxar?
Coulter Pharmaceuticals of South San Francisco and SmithKline Beecham of
Philadelphia have filed a biologics license application to the FDA for
Bexxar (tositumomab, iodine I-131 tositumomab) for relapsed or refractory
low-grade and transformed low-grade B-cell non-Hodgkin’s lymphoma. Bexxar
delivers targeted microradiation to CD20-positive cells.  The company says
it is able to radiate the tumor site while sparing normal tissue.
Phase-3 trial for nose drops for Kaposi’s
Cytran of Kirkland, Wash., has announced that patients are being recruited
for a phase-3 trial of IM862, self-administered nose drops for AIDS-
related Kaposi’s sarcoma. IM862 is a peptide that, according to the
company, has shown antiangiogenic and immune-suppression properties in
lab tests. In phase-2 trials, 37% of patients had a complete or partial
response and 48% had no disease progression while taking the drug.
Synergy against breast cancer
EntreMed of Rockville, Md., has begun a phase-1 trial of 2ME2
(2methoxyestradiol) in combination with Taxotere (docetaxel) for advanced
breast cancer. Preclinical studies have shown that 2ME2, an antiangiogenic
drug, and taxanes in combination can control tumor growth better than each
agent separately. A phase-1 trial of 2ME2 as a single agent for advanced
breast cancer has been completed.
Phase-2 for NSCLC SmithKline Beecham of Philadelphia
presented phase-2 data on Hycamtin (topotecan HC for injection) for non-
small-cell lung cancer, showing that among 42 evaluable patients one had a
complete response and five had a partial. Seventeen patients had stable
disease for at least 56 days, according to the study revealed at the World
Congress on Lung Cancer in Tokyo last week. Hycamtin, a topoisomerase I
inhibitor, is already approved as a second-line therapy for small-cell
lung cancer. This trial is testing the agent in combination with
carboplatin as a first-line treatment for non-small-cell lung cancer.
IntraDose is an orphan
Matrix Pharmaceuticals of Fremont, Calif., has received orphan-drug status
from the FDA for IntraDose Injectable Gel (cisplatin/epinephrine) for
metastatic malignant melanoma. According to the company, IntraDose is for
patients with predominantly skin and soft-tissue disease who cannot
tolerate or don’t respond to systemic chemotherapy. In clinical trials,
48% of 25 patients treated with the drug responded. IntraDose has already
received orphan-drug status for head-and-neck cancer, and the company is
filing for FDA approval for this indication.
Combo gets new phase-1/2
ImmunoGen of Cambridge, Mass., and SmithKline Beecham of Philadelphia have
begun a second phase-1/2 trial of HuC242-DM1/SB-408075 for colorectal and
pancreatic cancer. This additional trial of the agent, a tumor-activated
prodrug, will take place at the University of Chicago and evaluate a
weekly dosing protocol. In the first phase-1/2 trial, patients were given
a single dose and follow-up doses at three-week intervals if needed. The
company says patients with non-small-cell lung cancer may be included in
the new trial.

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