BioSpace News Archive

Big pharmas are having a good year so far in terms of FDA approvals.

XTL today announced that on October 17, 2017, it received a letter from the Listing Qualifications Department of the Nasdaq Stock Market indicating that the Company has failed to comply with the continued listing requirement that it maintain either a minimum of $2,500,000 in stockholders’ equity or $35,000,000 market value of listed securities or $500,000 of net income.

Gemphire plans to initiate a clinical study in patients suffering from fatty liver disease and NASH in the fourth quarter of 2017.

The new reactors have been installed in the 7,500 sq. ft. multi-purpose manufacturing facility which opened at the site in 2016.

505(b)(2) NDA on track for FDA submission in Q1 2018.

Kyomed announces its selection, in conjunction with project leader Neogia and project partner Bluesleep clinic, as a finalist in the 2017 MedStartup awards.

The trial will enroll approximately 100 FA patients randomized evenly to either 150 mg of omaveloxolone or placebo.

This awarded grant is part of BARDA’s Advance Development of Medical Countermeasures for Pandemic Influenza, which focuses on improving the government’s responsiveness to future pandemic threats.

Afrezza is the only inhaled rapid-acting mealtime insulin approved by the U.S. Food & Drug Administration.

Queen’s University Belfast have led the world’s largest research study using a diagnostic test developed by Almac Diagnostics, to better understand the biology of prostate cancer tumours.