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news.Essentialis To Submit Special Protocol Assessment For Hypertriglyceridemia
Essentialis plans to file a Special Protocol Assessment (SPA) with FDA for the pivotal study to support the NDA filing for its drug, DCCR. The drug is intended
Essentialis plans to file a Special Protocol Assessment (SPA) with FDA for the pivotal study to support the NDA filing for its drug, DCCR. The drug is intended
Anadys has reported the data for the final cohort of hepatitis C patients in a phase I clinical trial of ANA773. Its an oral inducer of endogenous interferons
Ranbaxy has received final approval from FDA to manufacture and market Sumatriptan Succinate Tablets, 25mg (base) and 50mg (base). The Office of Generic Drugs, FDA, has determined Ranbaxy
Avanir has reported that the investigational drug Zenvia (dextromethorphan/quinidine) has met its primary efficacy endpoint in the confirmatory phase III STAR trial, for the treatment of pseudobulbar affect
Cardium Therapeutics has reported its financial results for the second quarter ended June 30, 2009. For this period, the company reported a loss from operations of $2.3m, as
Cryo-Cell has signed an exclusive license agreement with S-Evans Biosciences, (SEB). The partnership will allow SEB to market and manufacture proprietary C’elle menstrual stem cell technology including the
Additionally, Olsen, who is the company’s current chief operating officer, will continue to serve in that capacity for both divisions while the board of directors engages in a
Nycomed and Forest Laboratories (Forest) have signed an exclusive development, manufacturing and commercialisation agreement in the US for Daxas (roflumilast). Its a once-daily oral treatment for patients suffering
Astellas Pharma (Astellas) reported that FDA has substantially denied its Citizen Petition to ensure the safe and effective use of immunosuppressants, used to prevent rejection in organ transplant
BioVectra has completed the manufacturing of DispersinB Topical Wound Gel under current Good Manufacturing Practices (cGMP). The required quality control (QC) tests, including sterility and DispersinB and alginate