Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amneal, Astrazeneca, Edesa, Everest, Hutchmed, Inmune, Ose, Pardes, Ryvu, Servier, Turn.
Following new positive top-line results from its pivotal phase III study of IPX-203, Amneal Pharmaceuticals Inc. said an NDA submission for the Parkinson’s disease therapy (PD) is now planned for the middle of 2022.
A potential new treatment for the rare condition Wilson disease moved a step closer to reality after Alexion Pharmaceuticals Inc., now part of Astrazeneca plc, announced positive top-line results from a phase III trial of ALXN-1840 (tiomolibdate choline). Astrazeneca’s shares (NASDAQ:AZN) ticked up following the announcement, closing Aug. 26 at $58.76, up 18 cents. From the point of view of the big U.K. pharma, it’s a good piece of news as it hopes to build a rare disease franchise from its $39 billion acquisition of Alexion, which was completed last month.
Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
Theravance Biopharma Inc.’s phase IIb fizzle with izencitinib in ulcerative colitis (UC) put a dent in shares, as Wall Street mulled the ongoing phase II study in Crohn’s disease (CD) as well as prospects regarding the deal with Johnson & Johnson.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bavarian Nordic, Foghorn, Hepagene, Kezar, Lexicon, Orphazyme Plus, Puretech, Sen-Jam.