FDA

FDA approves EYLEA injection

Monday, November 21, 2011 09:27 AM

The FDA has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every eight weeks (2 months).

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Industry watchers nervous as PDUFA V deadline looms

Monday, November 21, 2011 08:02 AM

PDUFA IV expires Sept. 30, 2012, and several parties already are nervous about its renewal. 

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FDA approves high dose anti-depressant

Thursday, November 17, 2011 11:45 AM

The FDA has approved IntelGenx' lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.

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Benchmark, poised for growth, adds two vice presidents

Monday, November 14, 2011 08:00 AM

Benchmark Research, an Austin, Texas-based group of six investigative sites, is making some strategic hires as it positions itself for growth.

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Rempex raises $67.5 million in Series B financing

Wednesday, November 9, 2011 02:06 PM

Rempex Pharmaceuticals has completed the initial closing of a Series B financing.  New investors Frazier Healthcare Ventures and Vivo Ventures joined existing investors SV Life Sciences, OrbiMed Advisors and Adams Street Partners in committing to a total of $67.5 million for this round.  This financing, together with a previous Series A round, brings the total financing commitment for Rempex to $76 million since the company's founding in June 2011.

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NPS Pharmaceuticals' phase III REPLACE study shows positive results

Monday, November 7, 2011 01:06 PM

NPS Pharmaceuticals has reported positive top-line results from REPLACE, a phase III registration study of NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism, a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus, and for which there is no FDA-approved replacement therapy. The symptoms of hypoparathyroidism are typically managed with large doses of oral calcium supplementation and active vitamin D therapy to reduce the severity of symptoms. The prolonged use of oral calcium supplementation and active vitamin D therapy may result in serious long-term health complications.

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Report: Clinical trials approved in Russia on course in third quarter

Monday, November 7, 2011 11:26 AM

The number of new studies approved in Russia during the third quarter of 2011 reached last year’s level, with the Ministry of Health and Social Development of the Russian Federation (MoH) approving 132 new clinical trials of all types, including local and bioequivalence studies, according to Synergy Research Group (SynRG), a Russia-based CRO. That’s only two trials below the number approved in the year-ago quarter.

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FDA approves XARELTOR

Monday, November 7, 2011 09:34 AM

The FDA has approved XARELTOR to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. XARELTOR is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without
the need for routine blood monitoring.

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Scrip names PPD best CRO

Friday, November 4, 2011 11:43 AM

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FDA approves 35 new drugs in fiscal year 2011

Friday, November 4, 2011 10:15 AM

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