Sage Therapeutics Inc.’s drug helped improve depressive symptoms after three days in a late-stage study, but investor concerns over how long the treatment’s effect would last sent the drug developer’s shares down 17% on February 16.
The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
AstraZeneca reported what the company called “unprecedented survival,” in the HIMALAYA Phase III trial using a single priming dose of tremelimumab added to the anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab) compared to Bayer’s Nexavar (sorafenib) as a first-line treatment for unresectable hepatocellular carcinoma (HCC) patients who had not received previous systemic therapy and as a result, were not eligible for localized treatment.
New real-world data from the ongoing BICSTaR study demonstrated the continuing benefits of treatment with Gilead’s HIV drug Biktarvy and quality-of-life issues faced by patients who have been treated with the medicine for one year.
AstraZeneca’s antibody cocktail against Covid-19, which has proven to work as a preventative shot in the non-infected, was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms.
A combination of Mirati Therapeutics Inc.’s genetic mutation-targeting adagrasib and Eli Lilly and Co.’s older cancer drug Erbitux shrank tumors in 39 percent of patients with advanced colorectal cancer treated in a small trial, the company said on Sept. 19.
Phathom Pharmaceuticals Inc. submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori infection in adults.
The U.S. Food and Drug Administration expanded the emergency use authorization of Regeneron Pharmaceuticals Inc.’s Covid-19 antibody cocktail, enabling the combo therapy’s use as a preventive treatment for the illness in certain people.
California-based biopharmaceutical firm BridgeBio Pharma announced a funding collaboration with Bristol Myers Squibb to evaluate a potential treatment for patients with difficult-to-treat cancers.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.