Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers September 19, 2017
Pharmacy Choice - Pharmaceutical News - FDA agrees to review cancer drug approval applications for Boulder's Array BioPharma [Daily Camera, Boulder, Colo.] - September 19, 2017

Pharmacy News Article

 9/13/17 - FDA agrees to review cancer drug approval applications for Boulder's Array BioPharma [Daily Camera, Boulder, Colo.]

Sept. 12The U.S. Food and Drug Administration has agreed to review two new applications from Boulder-based Array BioPharma (Nasdaq: ARRY) for a drug combination that's been shown to improve life expectancy for patients suffering from an advanced form of the skin cancer melanoma.

The two drugs, binimetinib and encorafenib, when used together have been shown to extend patients' lives using a benchmark known as progression-free survival, or PFS.

"We look forward to working with the FDA and EMA as they review our new drug applications for binimetinib and encorafenib," Array CEO Ron Squarer said in a statement.

The FDA set a target date for action of June 30, 2018, and told Array that, based on a preliminary review of the applications, no potential review issues have been identified.

In a study released at the 2016 Society for Melanoma Research Annual Congress, the use of the Array combination extended patients' lives by more than 14 months, compared to just more than seven months for other drugs being used to treat that type of melanoma.

Array, which employs some 200 people in Boulder, posted a loss of $116.8 million for its fiscal year ending June 30, on revenue of $150.9 million.

Those results represented a widening of losses compared with its 2016 fiscal year results, in which its loss stood at $92.8 million on revenue of $137.8 million, according to its 2017 annual report

Array's stock rose early in the day, according to Yahoo Finance, but was trading at $9.97 late in the afternoon, down from the previous day's close of $10.53. Its 52-week price range is $3.42 to $13.40.

Jerd Smith: 303-473-1332, smithj@dailycamera.com or twitter.com/jerd-smith

-

(c)2017 the Daily Camera (Boulder, Colo.)

Visit the Daily Camera (Boulder, Colo.) at www.dailycamera.com

Distributed by Tribune Content Agency, LLC.




Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Sep 20: What's New? New Treatments for Type 2 Diabetes
Sep 21: Biosimilar Drugs: Legal, Regulatory & Safety Considerations
Sep 22: Influenza 2017-2018: An Update on Prevention and Treatment
Sep 24: Using Effective Communication to Reduce Medication Errors
Sep 25: Management of Major Depressive Disorders
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415