More than a month ahead of its Nov. 27 PDUFA date, the U.S. FDA has approved Genentech Inc.’s first-line breast cancer treatment Itovebi (inavolisib). Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The regimen cut the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in a pivotal phase III study. The priority NDA had a Nov. 27 PDUFA date. Genentech is a unit of Basel, Switzerland-based Roche Holding AG.

Alnylam’s founder brings in a $135M series A for City Therapeutics 

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. “There’s room for new innovation to rethink the nature of the RNAi molecule and how it can be engineered and designed,” Maraganore told BioWorld. “That’s the work we want to pursue at City.”

Gilead ends $785M Yuhan deal for small-molecule MASH drugs 

Gilead Sciences Inc. terminated a potential $785 million licensing deal with Yuhan Corp. inked in 2019 to develop metabolic dysfunction-associated steatohepatitis (MASH) therapies. “Gilead notified the termination of the contract and return of rights [to the therapies] on Oct. 11,” Yuhan disclosed on the Korea Exchange. “Yuhan plans to search for new indications for the aforementioned MASH therapy and seek new [licensing] partners.” Yuhan noted that the $15 million received as up-front payment from Gilead will not be returned. The company’s shares (KOSPI:000100) on the KRX still rose by 1.64% Oct. 11, closing at ₩161,300 (US$119.41) at the bell.

2024 a record year for biopharma deal activity despite September slowdown

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.

A novel mRNA-LNP vaccine facilitates Clostridioides difficile control

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.

BioWorld Insider podcast: Gene and cell therapies will propel innovation, says Astellas CCO 

Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in this 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.” Zieler also shared his thoughts on creating sustainable health care in aging societies, the innovation cycle gap between the U.S. and Europe, and how collaboration between business and government is critical in forging ahead in this wide-ranging discussion.

Also in the news

Alkem, Astellas, Alvotech, Bio-Thera, Boehringer, Ciconia, Circle, Cosmo, Eli Lilly, Gedeon Richter, Gemma, Gritstone, GSK, Immatics, Insitro, Janssen, Johnson & Johnson, Kezar, Lipocine, Mirum, Myrtelle, Nona, Overt, Pfizer, Qinotto, Sonnet, Sumitomo, Takeda, Xortx