AHA: ARBITER 6-HALTS — Are There Any Clinical Implications? (CME/CE)

ORLANDO (MedPage Today) — The ARBITER 6-HALTS trial raises as many questions about using surrogate endpoints to approve drugs as it does about the efficacy of the actual drugs studied, niacin and ezetimibe.

AHA: Surrogate Endpoints Not Easy to Interpret

ORLANDO (MedPage Today) — A growing number of clinical trials use biomarkers or measurements obtained by imaging to gauge the effectiveness of treatment, but their use makes it difficult to interpret the findings, as this second of two InFocus™ segments devoted to surrogates makes clear.

High-Dose Capsaicin Patch Approved

The FDA has approved a dermal patch delivering 8% capsaicin, tradenamed Qutenza, for postherpetic neuralgia.

FDA Warns of Wound Therapy Complications

WASHINGTON (MedPage Today) — Negative pressure wound therapy (NPWT) may, rarely, cause bleeding, infection, and death, the FDA cautioned.

Lee’s Pharmaceutical granted exclusive license to Jennerex’ lead product for HCC

Jennerex, Inc., a clinical-stage biotherapeutics company developing a proprietary breakthrough class of targeted oncolytic virus therapeutics, today announced in conjunction with Lee’s Pharmaceutical Holdings, the execution of a collaboration and license agreement for Jennerex’s lead product candidate, JX-594, in certain Asian territories.

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

Epiphany Biosciences announces results from its valomaciclovir Phase 2b trial for shingles

Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The study’s primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash.

Data on Synta Pharmaceuticals’ STA-9090 synthetic inhibitor of Hsp90 presented

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that preclinical data presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics shows that STA-9090, a novel, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated strong activity in multiple tumor [...]

Recent data from CNSBio’s Phase IIa CNSB015 trial to be presented at the Neuropathic Pain conference

CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA.

Clinical Data commences patient enrollment in Stedivaze Phase III trial

Clinical Data, Inc. today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method [...]