For years, the biopharma industry has spent increasing amounts of money on R&D without improving success rates, leaving many executives searching for new, more predictable drug development paths.
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are not going gently into the night. Instead, they’re raging against what could be the dying of the light. The 17 raised their collective voices in a June 16 JAMA opinion piece to decry what’s at stake with Health and Human Services Secretary Robert Kennedy’s efforts, in his words, to “reestablish public confidence in vaccine science” by cleansing ACIP of what he claimed were conflicts due to members’ financial ties to industry.
The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating random strings of amino acids, using Alphafold to predict their structure, and then iteratively optimizing the design.
With plenty of GLP-1 money to spend, Eli Lilly and Co. is buying Verve Therapeutics Inc. and its gene-editing program for about $1.3 billion. Two of Verve’s one-time treatments are in the clinic. Lead candidate VERVE-102, a gene-editing treatment targeting PCSK9, is in a phase Ib study to reduce cholesterol levels.
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Merck, Moderna, Sumitomo, Urogen, Xediton.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astria, Beam, Bioarctic, Biorestorative, Celldex, Enliven, Incyte, Johnson& Johnson, Kancera, Keymed, Silence.