Xeris Raises $55M for Glucagon Rescue Pen
Xeris Pharmaceuticals secured $45 million in a Term Loan and Securities Agreement with Silicon Valley Bank and Oxford Finance, as well as closing a Series C financing with an additional…
Voyager Therapeutic's Parkinson's Trial Shows Positive Results
Voyager Therapeutics released longer-term data from its ongoing Phase Ib clinical trial of VY-AADC in advanced Parkinson’s disease. Source: BioSpace
MyoKardia Sees Positive Results in Mid-Stage Heart Trial
MyoKardia Inc. revealed positive results from a mid-stage obstructive hypertrophic cardiomyopathy trial. Source: BioSpace
AcelRx Pharma Plans to Resubmit New Drug Application for Dsuvia
AcelRx Pharmaceuticals plans to resubmit the NDA for Dsuvia in the second quarter of this year. Source: BioSpace
9 signs it's time to find a new job
“Of all the strategems, to know when to quit is the best.” – Chinese Proverb. Knowing the right time to make a change at work is a sign of wisdom…
FDA Advisory Panel Recommends 10mg Xeljanz Dosing Regimen
A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate…
No Safety Risk in Switching From Reference Drugs to Biosimilars, Study Finds
Switching from a reference medicine to a biosimilar does not affect patient safety, according to a data review by a research team that looked at 90 studies involving 14,225 subjects…
Gottlieb, Marks Explore Regulatory Pathways for Stem-Cell Development
The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for…
Pacific Hospital Supply Warned for Validation, Process Control Issues
The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan…
ZOLL Draws Form 483 for Environmental Control Problems, Complaint Files
The FDA cited ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Source: The GMP…
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