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Mission Pharmacal Company announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for over-the-counter liquid Potassium Iodide Oral Solution USP. The solution is a ready to use thyroid blocking medication that can be used by all ages in the event of a nuclear emergency.
Roche announced that Alecensa® , an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK-inhibitor.
VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, South Korea announced that the U.S. Food and Drug Administration FDA has granted Fast Track designation for the Companys lead investigational drug, VM202, a Phase 2 novel gene therapy for the potential treatment of Amyotrophic Lateral Sclerosis, ALS.
ViroMed is anticipating the publication of data from the Phase 1/2 trial of VM202 in ALS in the second half of the year. The primary endpoint of the trial was the safety and tolerability of VM202, and measures of the ALS Functional Rating Scale (ALSFRS-r) and other efficacy parameters were studied as secondary endpoints.
"We are very pleased to announce that the FDA has granted Fast Track designation for VM202 in the potential treatment of ALS. This status underscores the need to expedite potentially new and important treatment options for the ALS community," said Dr. Seungshin Yu, head of new business development of ViroMed Co., Ltd. "The Fast Track designation, coupled with the recent Orphan Drug designation from the FDA, provides even more momentum in our work to address the urgent and significant unmet medical need that remains in the treatment of people with ALS."
Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly cut down the development time and cost associated with bringing a drug to market, and the orphan-drug designation also allows for 7 years of market exclusivity even after expiration of related patents.
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