Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease. Read More
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat. Read More
The market downturn has left many biopharma companies searching for new ways to raise funds, with some eyeing the strong venture capital market as a potential resource. But having a disruptive technology and solid data may be the best way to stand out in a sea of companies, say financial executives that participated Feb. 6 in a panel discussion during the first full day of the BIO CEO 2023 conference in New York. Read More
Shares in Idorsia Ltd. plummeted by around 14% Feb. 6 as the company announced that its phase III REACT trial investigating the use of Pivlaz (clazosentan) failed to reach the primary endpoint in patients who had experienced a type of stroke called aneurysmal subarachnoid haemorrhage, leaving the drug’s future in the U.S. and Europe uncertain. Read More
In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position. Read More
The U.S. Government Accountability Office (GAO) has sounded off again about the ability of other federal government agencies to respond to future crises and pandemics, arguing that the Department of Health and Human Services (HHS) has not forged a comprehensive assessment mechanism to account for the associated medical countermeasure production needs. However, GAO also remarked that HHS does not have a dedicated funding mechanism to finance these activities, a resource that might not become available until after HHS officials draft a budget for the activities associated with such efforts for congressional review. Read More
New hires and promotions in the biopharma industry, including: Astellas, Blue Water Vaccines, Clearside, Concerto, Cyteir, Halozyme, Lava, Newamsterdam, Nutcracker, Scholar Rock, Silence, Viridian. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Defence, Merck & Co., Moderna, Personalis, Qurient, Pharmather, Revive. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Gracell, Maat, Octapharma, Orexo, Pharmala, Psycheceutical. Read More
