AstraZeneca is examining the impact of a new coronavirus variant that is spreading rapidly in South Africa on the company’s vaccine and antibody cocktail, and is hopeful that the combination drug would retain efficacy.
With the Thanksgiving holiday upon us, BioSpace felt it was important to give thanks for some of the positive things that have happened during 2021. And there are many! The accomplishments, opportunities and possibilities the scientific community has brought to bear, providing a way out of the COVID-19 pandemic and hope for the future of meaningful therapies for several challenging diseases, deserve a major shout-out.
Shares of Kura Oncology plunged in trading on November 24 after the San Diego-based company announced the U.S. Food and Drug Administration placed a partial clinical hold on a Phase Ib leukemia study assessing KO-539 following the report of a patient’s death.
A cardiovascular drug Pfizer licensed from Akcea Therapeutics in 2019 hit the mark in a Phase IIb dose-ranging study in patients with elevated non-HDL-C and triglycerides.
The Food and Drug Administration cleared the way for Tonix Pharmaceuticals to begin a Phase II study of the company’s therapeutic candidate, which intends to prevent migraine headaches.
Glympse Bio has developed a liquid biopsy with the potential to diagnose and monitor non-alcoholic steatohepatitis (NASH) with significantly higher accuracy and less invasiveness than needle biopsies, according to a late-breaking presentation at the American Association for the Study of Liver Disease (AASLD) annual The Liver Meeting.
Merck’s HIV strategy took a major hit as a “very important” aspect, MK-8507, was paused in development after patients experienced a low white blood cell count. East coast neighbor Enanta is also feeling the sting of a failed program with HBV trials, as the Massachusetts biotech is dropping the oral hepatitis B virus RNA destabilizer EDP-721 after healthy participants experienced safety signals.
A new study shows that there might be a way to protect against influenza infection without needing to stir up antibody response.
The U.S. Food and Drug Administration approved Covid-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
Gilead Sciences Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.
