FDA

Marshall Edwards initiates phase I ME-143 trial

Friday, September 9, 2011 12:48 PM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has initiated a phase I clinical trial of its lead drug candidate ME-143 in patients with refractory solid tumors. The trial is being conducted in collaboration with the Sarah Cannon Research Institute in Nashville, Tennessee, following the approval of an Investigational New Drug (IND) application by the FDA last month.

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FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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FDA approves Lupin’s UltramR ER

Wednesday, August 31, 2011 01:04 PM

Lupin Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ERshortly.

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Aterena Zentaris’ AGHD study shows favorable results

Tuesday, August 30, 2011 12:03 PM

Aeterna Zentaris has reported favorable top-line results of its completed phase III study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The results show that AEZS-130 reached its primary endpoint demonstrating >90% area-under-the-curve (AUC) of the Receiver Operating Characteristic curve, which determines the level of specificity and sensitivity of the product. The company is currently proceeding with further detailed analyses of the data and preparing for a pre-New Drug Application (NDA) meeting with the FDA in the upcoming months, which would be followed by the filing of a NDA for the registration of AEZS-130 in the United States.

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AiCuris’ Letermovir receives Fast Track designation

Monday, August 29, 2011 12:58 PM

AiCuris announced today that the FDA has granted Fast Track designation for one of its lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).

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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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