BioSpace News Archive

FDA

Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA

In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.

April 16, 2018
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2 min read
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Alex Keown
CRISPR Therapeutics Plans to Treat First Patients for Beta Thalassemia in Europe

The plan is to treat patients with beta thalassemia, a blood disorder that decreases the production of hemoglobin, the iron-containing protein in red blood cells that carries oxygen.

April 16, 2018
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3 min read
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Mark Terry
Roche Diagnostics Assay Receives FDA Clearance for STD Testing

Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.

April 16, 2018
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2 min read
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Alex Keown
Drug Development

Bristol-Myers Squibb Shares Drop on Positive Lung Cancer Trial

Bristol-Myers Squibb announced initial positive Phase III data, yet company shares dropped more than six percent.

April 16, 2018
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2 min read
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Mark Terry
Are You Cut Out For Remote Work?

Remote work, working from home, telecommuting… the number of companies who are offering a flexible work environment or 100% remote jobs is increasing as technology enables employees to, literally, work from anywhere.

April 16, 2018
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7 min read