logo
Plus   Neg
Share
Email

Gilead Sciences Plans To Submit NDA For Filgotinib To FDA In 2019

Gilead Sciences, Inc. (GILD), a research-based biopharmaceutical company, announced its intent to submit new drug application or NDA for Filgotinib as a treatment for rheumatoid arthritis to U.S. Food and Drug Administration in this year.

Filgotinib is an investigational agent and not approved anywhere. Its efficacy and safety is yet to be established.

At a recent pre-NDA meeting with the FDA, the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib. The company said it discussed the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn's disease.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Video game retailer GameStop Corp. laid off more than 120 employees, or nearly 14 percent of the total workforce at its corporate headquarters and at some other offices, according to reports. The layoffs also include senior editorial staff at Game Informer, the company's print and digital publication. Some of the senior staff at Game Informer took to Twitter to announce about their layoffs. Uber Technologies Inc. will establish a new U.S. general and administrative hub in Dallas, which will create 3,000 new jobs and more than $75 million in capital investment, Texas Governor Gregg Abbott said. Uber will get a grant of $24 million from the Texas Enterprise Fund or TEF, a business incentive fund that is used for attracting new business to the state and to ensure their growth. SAMpark LLC recalled 185 Children's pajama sets for burn injury risk to children. The pajamas failed to meet the flammability standard for children's sleepwear that requires sleepwear to be either snug-fitting or flame resistant. However, there have been no incidents or injuries reported so far.
Follow RTT