Merck & Co. Inc. is getting the exclusive, global rights from Orion Corp. to develop the oral prostate therapy, ODM-208, which the two companies hammered out a deal for in 2022. Orion could now bring in up to $30 million in development milestones, as much as $625 million in regulatory milestone payments, and up to $975 million in sales-based milestones. The deal adds up to $1.6 billion for Espoo, Finland-based Orion. Orion, which has a number of other deals with other companies, could also receive annually tiered royalty payments ranging from a low double-digit rate up to a rate in the low 20s on net sales for any commercialized licensed product. Read More
At a time when much of the biopharma space can’t seem to get enough of antibody-drug conjugates (ADC), Bristol Myers Squibb Co. is backing away from a potential $3 billion-plus collaboration with Eisai Co. Ltd., handing back full rights to the latter’s folate receptor alpha-targeting ADC, farletuzumab ecteribulin (FZEC), citing a portfolio reprioritization. Global rights to FZEC now reside with Tokyo-based Eisai, which said it intends to accelerate work on the candidate, which is in three clinical studies, including two phase II trials in gynecological cancers and non-small-cell lung cancer. Read More
In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief. Read More
Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis. Read More
In the first five months of 2024, the BioWorld Neurological Diseases Index (BNDI) saw a 10.35% decline, underperforming both the Nasdaq Biotechnology Index (NBI), which rose by 0.7%, and the Dow Jones Industrial Average (DJIA), which increased by 2.64%. This represents an additional drop for BNDI, which closed February with a 4.1% decline. In contrast, in 2023, the BNDI closed with a 4.36% increase, outperforming the NBI, which rose by 3.74%, but not matching the 13.7% rise seen in the DJIA. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbisko, Attgeno, Capricor, City of Hope, Eisai, Elicio, Immutep, Innovent, Merck, Osel, Recce, Redx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Carisma, Daiichi, EA Pharma, Eisai, Ensho, Moderna, Pfizer, Seagen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Apellis, ARS, Iovance, Janssen, Merck, Mirum, Moderna, Pfizer, PTC, Regeneron, Rhythm, Roche, Rocket, Shorla, Soleno. Read More
