The U.S. Health and Human Services and the Justice Departments are bringing more resources to their crack down on False Claims Act (FCA) violations involving drugs, medical devices and Medicare fraud.
After falling 4.74% in the first quarter (Q1), the BioWorld Cancer Index (BCI) staged a strong recovery in Q2, ending the period up 12.78%. The broader markets followed a similar trajectory, with the Dow Jones Industrial Average rebounding from a 4.41% loss at the end of April to close Q2 with a 3.64% gain. The Nasdaq Biotechnology Index also improved, trimming its earlier 5.37% decline to finish June down just 1.92%.
The first systematic whole genome sequencing study of how chemotherapy damages healthy tissues has shown that many, but not all, of these agents cause mutations and premature aging of normal blood cells.
Exelixis Inc.’s positive phase III top-line data June 22 with zanzalintinib (zanza) in colorectal cancer had Wall Street speculating anew about the odds with the tyrosine kinase inhibitor in an important indication.
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
Aussie researchers have used CRISPR gene editing tools to “armor” chimeric antigen receptor (CAR) T cells to activate additional cancer-fighting proteins at the tumor site, enabling them to target cancer cells in solid tumors.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camurus, Clene, Hemispherian, Jazz, Mesoblast, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Alvotech, Advanz, Bergenbio, Beacon, Bioeq, Biomarin, Bio Usawa, Concentra, Ho’ola, IGM, Inozyme, Merck, Oncoinvent, Oncternal, Protagonist, Torii, Verrica.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Arcturus, Atai, Beckley, Cytodyn, I-Mab, Mineralys, Sensorion, Verastem.
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