Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
While Nrx Pharmaceuticals Inc.’s oral antidepressant NRX-101 failed, producing a not statistically significant 33% reduction in suicidality along with a 70% reduction in the symptoms of akathisia, the company said it plans to forge ahead and conduct a registrational study.
Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate response to that treatment.
Boston-based South Korean biotech Genosco Inc. said on April 25 that it passed a technology review required for the special listing track on the tech-heavy Kosdaq market, as it readies an IPO on the Korea Exchange.
Researchers from State University of New Jersey (Rutgers) and Oklahoma State University have published preclinical data for a novel a SARS-CoV-2 papain-like protease (PLpro) inhibitor being developed as an antiviral candidate for the treatment of COVID-19.
Boston-based South Korean biotech Genosco Inc. said on April 25 that it passed a technology review required for the special listing track on the tech-heavy Kosdaq market, as it readies an IPO on the Korea Exchange.
Researchers from China Pharmaceutical University published the design and preclinical characterization of novel potent and selective CDC2-like kinase 2 (CLK2) inhibitors as potential candidates for the treatment of osteoarthritis.
Researchers from Shenyang Pharmaceutical University and affiliated organizations have reported the identification of a selective cyclin-dependent kinase 9 (CDK9) inhibitor, CLZX-205, being developed for the treatment of colorectal cancer.
Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a potentially registrational phase II trial across multiple tumor types, ACR-368 also raised the stakes for Boundless Bio Inc., which is developing CHK1 inhibitor BBI-355.
Researchers from the Chinese Academy of Sciences and affiliated organizations discovered a new ubiquitin-specific protease 7 (USP7) inhibitor, YCH-2823, being developed as a potential anticancer agent.
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