Tyra Biosciences Inc.’s recent deal with Xcures Inc. drew more attention to the already popular FGFR inhibitor space in oncology, as the pair made known a collaboration on a real-world biomarker study involving patients with FGFR-mutant bladder cancer who are given once-daily, oral Balversa (erdafitinib, Johnson & Johnson), a pan-FGFR blocker approved in April 2019.
A new antibiotic combination developed by Venatorx Pharmaceuticals Inc. "may represent a significant improvement over the standard of care" for adults with complicated urinary tract infections (cUTI), said Christopher Burns, the company's co-founder, president and CEO.
Ahead of data due any day from Turning Point Therapeutics Inc. with repotrectinib (repo) in ROS1-positive non-small-cell lung cancer (NSCLC), CEO Athena Countouriotis said her firm’s product already is differentiating itself from the likes of Xalkori (crizotinib, Pfizer Inc.) and Rozlytrek (entrectinib, Roche Holding AG).
Partners Sanofi SA and Swedish Orphan Biovitrum AB (Sobi) said regulatory submissions are expected this year for once-weekly factor VIII therapy efanesoctocog alfa in hemophilia A following top-line success in a pivotal phase III study, which showed a clinically meaningful prevention of bleeds in people with severe disease receiving prophylaxis over 52 weeks. The drug, also known as BIVV-001, has fast track and orphan designations in the U.S., and the companies are banking on its extended half-life to go up against blockbuster bispecific antibody Hemlibra (emicizumab) from Roche Holding AG as well as a potential gene therapy from Biomarin Pharmaceutical Inc.
As the conflict in Ukraine intensifies following the Russian invasion, hundreds of clinical trials could be in jeopardy amid the chaos and destruction of war, with pharma giant Merck & Co. Inc. saying it is putting recruitment for dozens of studies on hold.
A patient’s death has caused the FDA to place a partial clinical hold on Alpine Immune Sciences Inc.’s phase I study NEON-2 in adults with advanced malignancies.
As Neubase Therapeutics Inc. gears up to unveil preclinical data from its myotonic dystrophy type 1 (DM1) effort during the MDA Clinical & Scientific Conference later this month, investors are watching other programs moving through pipelines – but none of the research, except for that underway by Avidity Biosciences Inc., has entered the clinic.
Hutchmed Ltd. has received a $15 million milestone payment from Astrazeneca plc for initiating a phase III trial testing the Hutchmed c-Met inhibitor Orpathys (savolitinib) in combination with Astrazeneca’s Tagrisso (osimertinib) in epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) for patients with mesenchymal epithelial transition receptor (MET) driven tumors.
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms.