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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
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
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
The Cambridge, Mass., drugmaker earned $18.5 billion in total revenue for 2021, almost all of which was from sales of its coronavirus vaccine. Read More
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
A biologics-focused subsidiary of Bangalore, India-based Biocon is buying the biosimilars portfolio of Pittsburgh, Pa.-based Viatris for up to $3.3 billion. Read More
The FDA outlined its latest thinking on patient-focused drug development in a final guidance released on Friday, including ways to gather information that can be used for trial design. Read More