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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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Oncolytics Biotech completes patient enrollment in phase II ovarian cancer study

Friday, September 5, 2014 09:53 AM

Oncolytics Biotech has completed patient enrollment in a randomized, phase II study of paclitaxel plus reolysin versus paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

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Debiopharm Group's antibiotic Debio 1450 receives QIDP designation from the FDA

Friday, September 5, 2014 09:40 AM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, has announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

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The CenterWatch Monthly, September 2014

Tuesday, September 2, 2014 07:00 AM
Today’s fastest, most economical sponsors

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