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news.FDA issues complete response letter for GSK’s cervical cancer vaccine
A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research when the review of a file is completed and questions remain to be answered
A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research when the review of a file is completed and questions remain to be answered
According to the results, asenapine 5mg twice daily and 10mg twice daily were both significantly more effective than placebo at improving patient positive and negative syndrome scale (PANSS)
Accordingly, Lilly and BioMS Medical will collaborate on the development of MBP8298 and will also share in certain development costs with Lilly being responsible for future R&D, manufacturing
On issuance, the patent will expire in 2022. The company said that the subsequently filed patent applications which broaden its patent position could extend the patent life for
Impax said that the FDA has requested the company to provide notification to Endo and Penwest of this certification. This paragraph IV certification notice refers to Penwest’s patents
The company said that tanespimycin is clearly active in patients who are refractory to trastuzumab and whose disease progressed prior to entering the study. Of 20 evaluable patients,
The two-year study will use the Corgenix hyaluronic acid (HA) test kit alone and in combination with other liver fibrosis biomarkers, to develop a predictive model for liver
This current study will test the long-term safety and tolerability of Vilazodone and will enroll patients at 40 sites in the US. A second pivotal trial will continue
With its acquisition of Encode, Bennu has obtained intellectual property rights related to EC Cysteamine, including an exclusive worldwide license to develop and market a product which has
The company’s pandemic influenza vaccine candidate is currently in Phase I/IIa clinical trials. In a study using mice, two injections of Novavax’s trivalent seasonal flu vaccine without an