The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies. Bristol Myers Squibb Co., which acquired Cobenfy developer Karuna Therapeutics Inc. for $14 billion in a deal that closed in March 2024, said the drug will be available in the U.S. from late October.
Roivant Sciences Ltd. has sold another company, this time offering up Dermavant Sciences Ltd. to Organon & Co. for $1.2 billion. The deal brings Organon into a crowded market for plaque psoriasis treatments. The massive amount comprises an up-front $175 million payment, along with a potential $75 million regulatory milestone and up to $950 million in commercial milestones. In the deal, Organon brings in Vtama (tapinarof) cream, a topical, aryl hydrocarbon receptor agonist for mild, moderate and severe plaque psoriasis in adults.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced Aug. 15 for the 10 drugs selected for the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector.
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Scientists from Abbvie Inc. and the Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center have discovered a new allosteric MALT1 inhibitor, ABBV-MALT1, for the treatment of certain types of diffuse large B-cell lymphoma (DLBCL).
Frontier Medicines Corp. has advanced lead candidates for further optimization in an Abbvie Inc.-partnered program targeting a key transcription factor for cancer cell survival, triggering an accompanying milestone payment.
