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Clinical Intelligence

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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Report: Research indicates mangos may lower blood sugar in obese adults

Friday, September 12, 2014 01:08 PM

Regular consumption of mango by obese adults may lower blood sugar levels and does not negatively impact body weight, according to research published in the journal Nutrition and Metabolic Insights. These are important findings considering that approximately 34% of U.S. adults have been classified as obese and given the health concerns related to obesity, such as type 2 diabetes (T2DM) and metabolic syndrome.

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FDA approves weight-management drug Contrave

Friday, September 12, 2014 12:49 PM

The FDA has approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

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VentiRx Pharmaceuticals receives Fast Track designation for Motolimod (VTX-2337)

Friday, September 5, 2014 10:59 AM

The FDA has granted Fast Track designation to VentiRx Pharmaceuticals’ motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled, phase II trials.

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November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
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