Merck's Zinplava, or bezlotoxumab, has been approved by the FDA for use in conjunction with antibacterial treatment to reduce the recurrence of Clostridium difficile infection in adult patients with a high risk of CDI recurrence. The drug will be launched commercially in the first quarter of 2017.
The European Medicines Agency has begun publishing results of all trials submitted to the agency on an online database, whether the product is ultimately approved, rejected or withdrawn, to promote transparency of clinical data. The agency, which released data for Kyprolis and Zurampic on Thursday, expects to publish 4,500 reviewed and redacted clinical reports annually.
The FDA and the CMS have announced they are extending indefinitely their parallel review program for innovative medical devices, which aims to shorten the period between the issuance of a de novo or a premarket approval and a Medicare coverage decision. The pilot program prioritizes technologies that are "expected to have the most impact on the Medicare population" and are likely to secure approval, the agencies said.
Intermountain Healthcare will launch a genomic testing and research firm named Navican, which will help provide personalized treatments for patients with advanced cancer. Patients in Intermountain's system can be tested through Navican's next-generation sequencing platform that determines the range of genes affected by cancer and suggests personalized treatment options.
Washington State University researchers are developing a biotech soybean that grows larger, produces more seeds and has improved nitrogen flow compared with traditional soybeans. The researchers introduced a gene from a bean into the soybean, which could require less fertilizer while improving yield.
Kaleo Pharma's new-drug application for a 2-mg dose of Evzio, or naloxone HCl injection, has been approved by the FDA, permitting the drug's use as an emergency treatment for known or suspected opioid overdose. Evzio was approved in 2014 in a 0.4-mg strength.
Infectious disease specialist Kate Rubins, who is in the midst of a four-month assignment aboard the International Space Station, put off applying for an NIH grant and applied to be an astronaut. She described her research in a video chat with NIH Director Francis Collins and said she has sequenced more than a billion base pairs so far using a compact DNA sequencing device.
The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee has voted in favor of approving Allergan's low-dose nasal formula SER120, or desmopressin, for treating nocturia. However, the panel advised the FDA to restrict the drug's use to patients who have nocturnal polyuria.
Teva Pharmaceutical Industries' resubmitted new drug application for deutetrabenazine has been accepted for review by the FDA with a decision expected by April 3, 2017. The firm received a complete response letter last May regarding its original submission for the drug, which is designed to treat chorea associated with Huntington's disease.
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