While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.
Blood clots can lead to life-threatening conditions such as deep vein thrombosis, heart attack, pulmonary embolism and stroke. Blood thinners are essential in the treatment and prevention of blood clots but carry a significant risk of bleeding as they target enzymes essential for blood clotting. Researchers at the University of British Columbia (UBC) and the University of Michigan have developed a new class of blood thinners that can specifically target clots without increasing the risk of bleeding.
Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
Pattern Bioscience Inc. reeled in $28.7 million in a series C financing led by Illumina Ventures and Omnimed Capital. The money will be used to complete development of its rapid phenotypic test platform for infectious diseases, conduct clinical validation studies and submit the platform and Pattern’s initial test, for pneumonia, for U.S. FDA review.
Avertix Medical Inc. signed a definitive merger agreement with Bios Acquisition Corp., a special purpose acquisition company (SPAC), in a deal that will take the company public on the Nasdaq. The deal will establish the combined entity, which will continue under the Avertix name and trade as AVRT, with an estimated enterprise value of $195 million. The transaction is expected to close in the second half of the year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centricity Vision, Femasys.