In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million. Read More
Shares in Cytokinetics Inc. closed down 42% Oct. 8 on news that omecamtiv mecarbil, a heart failure drug which it is developing with Amgen Inc. (with funding and strategic support from Les Laboratoires Servier SAS), failed to demonstrate a survival benefit in a large-scale cardiovascular outcomes study. Read More
The appetite for biopharma IPOs this year has been voracious with no signs of a slowdown anytime soon. Year-to-date, a total of $14.63 billion was raised from 66 new global issues, a total that is already well ahead of the $10.7 billion in 2018, from 80 transactions, that represented the previous record for IPOs. In terms of volume, BioWorld has recorded that the highest number of IPOs in a single year was 84 in 2014, followed by 83 in 2000. Read More
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate). Read More
The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Oct. 6 at the Cleveland Clinic’s 2020 Medical Innovation Summit. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerecin, Eton, Neurocrine, Regeneron, Revelation, Rhythm AI, X4, Xenon, Xortx. Read More