FDA

FDA approves Shire’s FIRAZYR

Thursday, August 25, 2011 11:33 AM

The FDA has granted marketing approval for Shire’s FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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Par to acquire Anchen for $410 million

Thursday, August 25, 2011 11:17 AM

Generics drug maker Par Pharmaceutical has reached an agreement to acquire privately-held Anchen Pharmaceuticals, according to PharmaTimes.

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Bayer’s Radium-223 granted Fast Track Designation

Tuesday, August 23, 2011 12:58 PM

Bayer HealthCare Pharmaceuticals’ investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases.

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FDA creates modernization plan

Tuesday, August 23, 2011 12:43 PM

The FDA is prioritizing development of technologies to compare biosimilars to innovator products in its plan to modernize regulatory science.

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FDA accepts Alexza’s Adasuve NDA

Friday, August 19, 2011 10:33 AM

The FDA has accepted Alexza Pharmaceuticals’ ADASUVE New Drug Application (NDA) as a complete, class II response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.

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FDA approves first gene-targeted drug for Melanoma

Wednesday, August 17, 2011 12:05 PM

The FDA has approved Zelboraf, known as vemurafenib or PLX4032 during testing, well ahead of the approval deadline.  Zelboraf is the first drug to treat advanced melanoma by targeting a specific gene mutation.

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Marshall Edwards’ lead candidate ME-143 receives FDA approval

Tuesday, August 16, 2011 10:16 AM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has reported that its Investigational New Drug (IND) application for ME-143 (formerly NV-143),  the company's lead NADH oxidase inhibitor, has been approved by the FDA. The company plans to initiate a phase I clinical trial of intravenous ME-143.

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FDA issues guidance to improve clinical study quality

Monday, August 15, 2011 01:40 PM

The FDA has issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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FDA reviews BYDUREON, type 2 diabetes medication

Friday, August 12, 2011 02:48 PM

Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

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