With four complete response letters behind it and seven months ahead of its April 2023 PDUFA date, Mallinckrodt plc’s Terlivaz (terlipressin) has been approved by the U.S. FDA for treating hepatorenal syndrome. Terlivaz had a decade-long series of obstacles before getting the long-awaited approval. The vasopressin analogue selective for V1 receptors was approved, in part, on results from the phase III CONFIRM trial of 300 patients, which met its primary endpoint of renal function improvement, avoidance of dialysis and short-term survival (p=0.012). Read More
Immuno-oncology company Imugene Ltd. announced an AU$80 million (US$53.9 million) capital raise that will allow the company to add additional studies within its immuno-oncology pipeline as well as pursue potential licensing opportunities. The funds raised will allow the company to interrogate its pipeline further in other indications or combinations, Imugene CEO Leslie Chong told BioWorld. “There’s a lot we could do with our current pipeline, and now our cashflow is greatly extended.” Read More
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical officer at E-nitiate Biopharma. “The first step is to enter China’s autoimmune skin diseases market.” Read More
Altimmune Inc. has come under scrutiny from investors after weight loss data from a phase Ib trial of its nonalcoholic fatty liver disease drug, pemvidutide, sent its shares on a roller coaster ride. Read More
After a midstage trial showed no benefit from adding ELX-02 (exaluren) to Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) for certain cystic fibrosis (CF) patients, Eloxx Pharmaceuticals Inc. said it will discuss next steps for the program, its lead candidate, with the trial's sponsor, the CF Foundation. A proof-of-concept trial for EXL-02 in the rare kidney disease Alport syndrome will start later this year, the company said. Read More
Using a two-drug combination, researchers at the University of California at San Francisco (UCSF) have been able to achieve brain-specific inhibition of several kinases. Read More
With the science on aging advancing, it’s time for the U.S. to modernize its regulatory approval path for new longevity treatments, members of a House Science, Space and Technology subcommittee were told Sept. 15. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2022, including: Alphamab, Beyondspring, Triumvira. Read More
Biopharmas raising money in public or private financings, including: Akero, Alphyn, Biolinerx, Carver, Gameto, Ideaya, Rhythm, Third Harmonic, VBI. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocytogen, Caladrius, Cend, Fineimmune, IMV, Lista, Palisade, Qurient, Rigimmune, Subintro, Tenax, Tiziana. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Anbogen, Aqualung, ATMA, Avrobio, Atea, Biontech, Centessa, Genfit, Larimar, Mindset, Minoryx, Pfizer, Revive, Spectrum, Syros, Timber, Tracon, Transcenta, Triact. Read More
