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The FDA is making moves to improve how oncology trials are designed and conducted, publishing three final guidances on master protocol trials, first-in-human trials with expansion cohorts and the inclusion of older patients in earlier-phase cancer trials. Read More
Therapies based on the human gut microbiome are in the news with one company, Osel, releasing encouraging phase 1b data and another, Finch, receiving an FDA clinical hold during a phase 3 recruitment. Read More
Dozens of leaders in the global life sciences community are among the many who have signed an open letter condemning Russia’s invasion of Ukraine, calling it a “barbaric act that will lead to substantial loss of life, trauma to millions of people and the dislocation of civil society in a nation that has repeatedly expressed its peaceful intentions.” Read More
Antibody developer Adagene has forged a collaboration and exclusive license agreement with Sanofi to make masked monoclonal and bispecific antibodies. Read More
The results suggest that treatment with a one-time CRISPR-based therapy has the potential to substantially reduce levels of a disease-causing protein. Read More
A U.S. Patent and Trademark Office tribunal that oversees patent disputes has ruled that patents on CRISPR technology belong to Harvard University and the Massachusetts Institute of Technology’s Broad Institute — not to Jennifer Doudna of the University of California, Berkeley, and Emmanuelle Charpentier of the Max Planck Institute for Infection Biology, who were given the Nobel Prize in Chemistry in 2020 for first describing how CRISPR could be used to edit DNA in test-tube environments. Read More
The FDA has issued a Complete Response Letter (CRL) to Gilead Sciences for its new drug application (NDA) for lenacapavir, an HIV-1 capsid inhibitor for patients with HIV who are heavily treated and multidrug-resistant. Read More
AbbVie has completed its acquisition of Belgium-based Syndesi Therapeutics, broadening its neuroscience portfolio with several candidate drugs for treating a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. Read More
Pfizer is putting a positive spin on a C. difficile vaccine study that missed its two primary endpoints but scored some wins on secondary targets. Read More