Clinical Intelligence

CytRx receives multiple FDA Orphan Drug designations for Aldoxorubicin

Thursday, October 2, 2014 01:50 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has granted multiple Orphan Drug designations for the company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.

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Amgen reports positive results of two phase III studies of evolocumab

Thursday, October 2, 2014 12:46 PM

Amgen has announced data from two phase III studies, RUTHERFORD-2 and TESLA, that showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH). FH is an inherited condition caused by a gene mutation, which leads to high levels of LDL-C, or "bad" cholesterol, and premature cardiovascular disease.

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The CenterWatch Monthly, October 2014

Wednesday, October 1, 2014 06:00 AM

CROs driving changes in patient recruitment

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Amgen submits BLA for investigational BiTE immunotherapy blinatumomab

Thursday, September 25, 2014 02:55 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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Inovio expands HPV immunotherapy development to aerodigestive cancers

Thursday, September 25, 2014 02:51 PM

Inovio Pharmaceuticals has initiated a phase I clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability and immunogenicity of INO-3106. This immunotherapy targets human papillomavirus type 6 (HPV-6), which causes most aerodigestive cancers.

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Braeburn Pharmaceuticals' probuphine study hits enrollment milestone

Thursday, September 25, 2014 02:50 PM

Braeburn Pharmaceuticals has surpassed the midway point for patient enrollment in its phase III study of Probuphine, which began in July. Probuphine is a buprenorphine subdermal implant being studied for the maintenance treatment of opioid dependence. Completion of the study is on track for the middle of 2015, with submission of the New Drug Application to the FDA expected to follow later in the year.

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FDA approves STENDRA for ED

Thursday, September 18, 2014 02:21 PM

The FDA has approved a supplemental new drug application (sNDA) for Vivus’ STENDRA (avanafil). STENDRA now is the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

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Immune Pharmaceuticals initiates phase II clinical trial in ulcerative colitis

Thursday, September 18, 2014 01:10 PM

Immune Pharmaceuticals has initiated the screening of patients for a phase II proof-of-concept clinical trial exploring the safety and efficacy of bertilimumab in the treatment of ulcerative colitis (UC).

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FDA approves MOVANTIK (naloxegol) for opioid-induced constipation

Thursday, September 18, 2014 01:05 PM

The FDA has approved AstraZeneca’s MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain.

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Lilly’s CYRAMZA phase III colorectal cancer trial meets primary endpoint

Friday, September 12, 2014 01:35 PM

Eli Lilly has announced that the RAISE trial, a phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting.

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2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
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Ice Bucket Challenge a boon for ALS research
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Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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