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$Telik initiates Telintra Phase 2 trial in Revlimid refractory or resistant, del 5q MDS$

Telik initiates Telintra Phase 2 trial in Revlimid refractory or resistant, del 5q MDS

Telik, Inc. today announced the initiation of a Phase 2 clinical trial to evaluate oral Telintra in patients with Revlimid refractory or resistant, deletion 5q myelodysplastic syndrome.

8 Jun 2011

Health law challenges and appeals percolate

The date has been set -- July 13 -- for oral arguments to be heard in a California appeal of a lawsuit against the health overhaul filed by the Pacific Justice Institute. And, in Kansas, the attorney general has signed on to an amicus brief that supports, but does not join, in a lawsuit challenging the measure.

7 Jun 2011

NanoViricides' anti-influenza drug development studies to be presented at TechConnect World 2011

NanoViricides, Inc. announced today that it has been invited to present its anti-influenza drug development studies at the TechConnect World 2011 Conferences and Expo.

7 Jun 2011

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Acorda Therapeutics, Inc. today announced an analysis of pooled clinical trial results showed patients who were responders to AMPYRA (dalfampridine) Extended Release Tablets, 10 mg demonstrated clinically relevant improvements in walking ability as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), regardless of either their baseline Expanded Disability Status Scale (EDSS) score or baseline walking speed.

7 Jun 2011

Unique clinical trial addresses important questions about treating AIDS-related cancers

As the world marks the 30-year anniversary of the first reporting of HIV/AIDS, now comes the realization of a new challenge for people with the incurable disease. For reasons not yet clear, people with HIV face a higher rate of cancers not usually associated with HIV. This increasing rate of "non-AIDS defining cancers" includes lung, head and neck, liver, kidney, and anal cancers, among others.

7 Jun 2011

Ligand's LGD-4033 Phase I clinical trial data presented at the Endocrine Society annual meeting

Ligand Pharmaceuticals Incorporated today announced that data from a comprehensive Phase I multi-dose program with its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation today at the Endocrine Society Annual Meeting in Boston, June 4-7, 2011.

7 Jun 2011

Initial positive results from ZIOPHARM's ZIN-CTI-001 Phase Ib study against advanced melanoma

ZIOPHARM Oncology, Inc. announced today that Douglas J. Schwartzentruber, MD, FACS, of the Indiana University Health Goshen Center for Cancer Care, presented initial positive clinical results from the first-ever treatment demonstrating control over transgene encoding of a therapeutic anticancer protein in humans using a small molecule activator ligand.

7 Jun 2011

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc.,, today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

7 Jun 2011

SPI to commence enrollment in SPI-1005 clinical trial to prevent hearing loss induced by loud music

Sound Pharmaceuticals (SPI) will begin recruiting a new clinical trial testing the oral drug SPI-1005 to prevent the hearing loss induced by loud music. Exposure to loud music or noise can induce temporary and permanent auditory threshold shifts (TTS or PTS). In some people, a repeated TTS will ultimately give way to a PTS that is irreversible.

7 Jun 2011

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Letrozole Tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited.

7 Jun 2011

Exelixis reports encouraging interim data from cabozantinib phase 2 trial for metastatic CRPC

Exelixis, Inc. today reported updated interim data from the fully enrolled cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in a phase 2 adaptive randomized discontinuation trial (RDT).

7 Jun 2011

Non-steroidal, oral contraceptive for men

Researchers at Columbia University Medical Center are honing in on the development of what may be the first non-steroidal, oral contraceptive for men. Tests of low doses of a compound that interferes with retinoic acid receptors (RARs), whose ligands are metabolites of dietary vitamin A, showed that it caused sterility in male mice.

7 Jun 2011

Tragara's apricoxib-erlotinib Phase 2 study data on non-small cell lung cancer presented at ASCO 2011

Tragara Pharmaceuticals, Inc. announced today that apricoxib in combination with erlotinib demonstrated significant and consistent clinical benefit over erlotinib alone in a clinically relevant subset of biomarker-selected patients with non-small cell lung cancer (NSCLC) who had previously failed a platinum-containing regimen for advanced disease.

7 Jun 2011

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Lannett Company, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the company's 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution

7 Jun 2011

Testosterone spray may slow cognitive decline in post-menopausal women

Post-menopausal women have better memory after daily treatment with a testosterone spray for six months, a new preliminary study finds. The results will be presented Saturday at The Endocrine Society's 93rd Annual Meeting in Boston.

7 Jun 2011

Pivotal health law challenge heads to 11th Circuit Court of Appeals

A three-judge panel in Atlanta will hear oral arguments in the lawsuit brought by 26 states. At issue is whether a Florida judge's ruling to strike down large portions of the sweeping overhaul should be reversed.

6 Jun 2011

Generex not to proceed with acquisition of interest in Global Medical Direct

Generex Biotechnology Corporation today announced that the Company, together with Global Medical Direct, Inc. and its stockholders, have mutually decided not to proceed with the Company's previously announced acquisition of a 51% interest in GMD.

6 Jun 2011

Amylin's metreleptin clinical study data on partial lipodystrophy presented at ENDO 2011

Amylin Pharmaceuticals, Inc. today announced results from a study that showed treatment with metreleptin, an investigational treatment that is an analog of the human hormone leptin, improved diabetes and lipid control in patients with partial lipodystrophy.

6 Jun 2011

Chiasma presents Octreolin pharmacology data from clinical studies at International Pituitary Congress

Chiasma, Inc., a privately held biopharma company, presented pharmacology results from clinical studies at the 12th International Pituitary Congress showing that Octreolin, a proprietary investigational new oral formulation of octreotide, demonstrated a consistent pharmacokinetic (PK) profile similar to that of subcutaneously injected octreotide acetate.

6 Jun 2011

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

United Therapeutics Corporation announced today the completion of its FREEDOM-M Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).

6 Jun 2011

Oral News and Research

Telik initiates Telintra Phase 2 trial in Revlimid refractory or resistant, del 5q MDS

Health law challenges and appeals percolate

NanoViricides' anti-influenza drug development studies to be presented at TechConnect World 2011

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Unique clinical trial addresses important questions about treating AIDS-related cancers

Ligand's LGD-4033 Phase I clinical trial data presented at the Endocrine Society annual meeting

Initial positive results from ZIOPHARM's ZIN-CTI-001 Phase Ib study against advanced melanoma

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

SPI to commence enrollment in SPI-1005 clinical trial to prevent hearing loss induced by loud music

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Exelixis reports encouraging interim data from cabozantinib phase 2 trial for metastatic CRPC

Non-steroidal, oral contraceptive for men

Tragara's apricoxib-erlotinib Phase 2 study data on non-small cell lung cancer presented at ASCO 2011

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Testosterone spray may slow cognitive decline in post-menopausal women

Pivotal health law challenge heads to 11th Circuit Court of Appeals

Generex not to proceed with acquisition of interest in Global Medical Direct

Amylin's metreleptin clinical study data on partial lipodystrophy presented at ENDO 2011

Chiasma presents Octreolin pharmacology data from clinical studies at International Pituitary Congress

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

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