Release date: 2015-12-07
Medical development is a long-term process, and every drug must undergo a thorough test before it can finally enter clinical applications. Therefore, when the pharmaceutical company submits the clinical research data of the drug to the FDA, the feeling of embarrassment is naturally reasonable. And every decision of the FDA that holds the drug approval "killing power" will involve a multi-billion dollar drug project and even affect the fate of the company.
Therefore, what major decisions the FDA can make in the last month of 2015 are particularly eye-catching. Recently, 24/7 Wall St. in the United States analyzed four important decisions that the FDA may have in December, and the products of the four biopharmaceutical companies will be significantly affected.
First, Achillion Pharmaceuticals, Inc., the company's current vaccine therapy for the treatment of hepatitis C has been successful in early clinical research, and has begun the clinical phase II study. The company is expected to publish detailed research results for this study in the fourth quarter of 2015, so the FDA may make important decisions based on this research and influence the fate of the product.
Secondly, BCX4161, a drug developed by BioCryst Pharmaceuticals Inc. for the treatment of hereditary angioedema, is scheduled to be released by the end of this year. This drug project has recruited nearly 100 volunteers in the United States and several other countries. To evaluate the safety and efficacy of two different doses of this drug.
The third, possibly FDA-approved, is a new antibiotic drug developed by Tetraphase Pharmaceuticals, Inc., which is designed to treat a variety of drug-resistant Gram-negative bacteria. It is reported that the company will submit an NDA by the end of this year.
The last lucky one to be selected by the FDA is the anticancer drug lucitanib developed by Clovis Oncology, Inc., and researchers at Clovis are currently evaluating the drug for the treatment of refractory fibroblast growth factor (FGF) abnormal breasts. Clinical studies of cancer (in the United States) and advanced lung cancer (global range) with FGFR1 abnormalities.
Of course, this also means that FDA approvers will also have to go through a busy December. Whether the above four biopharmaceutical companies can receive the "Christmas spree" from the FDA as they wish, they have to rely on their own research and development data to speak.
Source: Bio Valley
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