Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.
Shares of Pharvaris NV (NASDAQ:PHVS) fell 34% Aug. 22 to close at $12.15 after the company reported the U.S. FDA placed a clinical hold on PHA-121, its oral bradykinin B2-receptor antagonist for hereditary angioedema (HAE), citing a review of nonclinical data. PHA-121, which goes after the same target as well-established injectable HAE drug Firazyr (icatibant, Takeda Pharmaceutical Co. Ltd.), is the active ingredient in Pharvaris’ two lead programs: PHVS-416, a softgel capsule formulation, and PHVS-719, an extended-release tablet formulation.
Kyowa Kirin Co. Ltd.’s decision, disclosed July 26, to quit development of the adenosine A2a receptor antagonist KW-6356 for Parkinson’s disease (PD) didn’t do much to flatten interest in the target, still under investigation by other firms in cancer.
The Project to Accelerate New Treatments for Tuberculosis is progressing two investigational tuberculosis combination treatment regimens into phase II trials under a joint development agreement.
Ryvu Therapeutics SA aims to move its lead drug candidate RVU-120 into three phase III trials in the first half of next year, to evaluate its potential in acute myeloid leukemia and high-risk myelodysplastic syndrome, in low-risk MDS, and in a number of solid-tumor indications.
The race to develop an oral selective estrogen receptor degrader (SERD) is under fresh scrutiny in light of Sanofi SA’s decision to axe development of its late-stage compound amcenestrant on Aug. 17, citing lack of efficacy in breast cancer trials. While there are concerns about the new class after Sanofi’s decision, a clear signal about its future could be growing nearer. The driver? Menarini Group and its development partner, Radius Health Inc., are advancing elacestrant, an oral SERD into regulatory reviews on both sides of the Atlantic.
Apollo Endosurgery Inc. released details of a landmark, multi-center randomized clinical trial demonstrating the safety and effectiveness of Apollo’s Endoscopic Sleeve Gastroplasty procedure (ESG) performed with the company’s endoscopic suturing system. The Merit study report comes on the heels of FDA market authorization of ESG as a minimally invasive, endoscopic weight loss therapy for patients suffering from obesity.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
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