DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics. Read More
Maintaining momentum for a rush of 2021 IPOs already on pace to beat 2020's record number, new offerings from Graphite Bio Inc., GH Research plc and Elevation Oncology Inc. raised nearly $500 million altogether on Friday. While shares of the first two fared well, climbing in their debuts, Elevation's shares (NASDAQ:ELEV) fell from $16 debut to $11.44 at the close, a 28.5% decline. Read More
Fulcrum Therapeutics Inc.’s phase IIb data with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) brought renewed hope for patients in what historically has proved a challenging therapeutic space. Though the firm’s oral p38 mitogen-activated protein kinase inhibitor missed its primary biomarker endpoint – changes in DUX4-driven gene expression – other indicators of benefit in the study called ReDUX4 painted a bright picture. Read More
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA. Read More
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates. Read More
Sometimes, scientific progress comes from conceptual insights that arrive in a flash. More often, however, such progress arrives in a decidedly less glamorous, though no less important, manner – through the development of new technologies in what can be a very slow iterative cycle of getting a new method to work. Read More
While the number of biopharma’s nonprofit deals and grants, as well as their values, have dropped by more than 20% compared with last year, almost 71% of the combined funds are targeting COVID-19 therapeutics, vaccines and other pandemic efforts. Read More
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market. Read More
The U.S. House Appropriations subcommittee passed an appropriations bill for the FDA that would add $257 million to the agency’s budget authority for fiscal year 2022, an increase of 8% over the currently enacted level. The Alliance for a Stronger FDA said in a June 25 statement that it will work to ensure the Senate comes up with similar numbers, characterizing the push to fully fund the agency as “a multi-year marathon, not a sprint.” Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Aquestive, Astrazeneca, Biogen Eli Lilly, Eisai, Huyabio, In3bio, Merck, Pieris, Roche, Santen, Vectivbio. Read More
