Genentech Inc. didn’t need to wait until Thanksgiving for the U.S. FDA to make up its mind. More than a month ahead of its PDUFA date, the agency approved the firm’s first-line breast cancer treatment, Itovebi (inavolisib), providing the oral therapy a place with other niched therapies from Astrazeneca plc and Novartis AG. Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and Faslodex (fulvestrant, Astrazeneca) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer. Read More
The founding CEO of Alnylam Pharmaceuticals Inc. is now leading the charge with newly launched City Therapeutics Inc., which just completed a $135 million series A financing. City’s executive chair, John Maraganore, will be in familiar territory as the new company plans to develop RNAi-based medicines using next-generation siRNA engineering. He expects dozens of these therapies to reach the market in a relatively short period of time, not just from City Therapeutics but from other companies. It’s a period in the development timeline that he finds reminiscent of the rise and development of monoclonal antibodies. Read More
Gilead Sciences Inc. terminated a potential $785 million licensing deal with Yuhan Corp. inked in 2019 to develop metabolic dysfunction-associated steatohepatitis (MASH) therapies. Read More
Biopharma deals in September amounted to $12.79 billion, marking a 20% drop in value from August’s $15.94 billion. Despite the month-to-month decline, the sector has seen strong momentum throughout the first three quarters of 2024, with total deal values reaching $149.02 billion. This represents a 14% increase from the $130.38 billion recorded during the same period in 2023, with 2024 remaining the highest year-to-date deal value on record for BioWorld. Read More
Clostridioides difficile has been traditionally isolated from health care facilities' inpatients, but it is increasingly being identified in people who have not recently been hospitalized and is more and more found in community settings. Investigators from Perelman School of Medicine at University of Pennsylvania have developed an mRNA-LNP vaccine with promising results in preventing and controlling C. difficile infection. Read More
Coming off September, which saw five biopharma IPOs raise more than $1 billion, two firms priced upsized offerings that could total more than $330 million. Read More
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.” Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Janssen, Mirum. Read More
