Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tough time outside the U.S. The EMA’s Committee for Medicinal Products for Human Use (CHMP) came out with a negative opinion on an MAA for treating KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC). The ruling came with a flurry of positive CHMP opinions for companies, including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos., plus a mixed result for Ipsen SA after a stumble earlier this week. Read More
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive. Read More
Pursuing tumor-infiltrating lymphocytes (TILs), Turnstone Biologics Inc. raised about $80 million in an IPO, offering 6.7 million shares at $12 each. The firm is “pioneering a differentiated approach to TILs,” with next-generation products designed by choosing the most potent and tumor-reactive T cells, dubbed Selected TILs, according to SEC paperwork. Read More
Investment in life sciences in the U.K. in 2022 was 47% lower than in 2021, new figures from the government show, a decline the British pharma industry believes is down to the high clawback rates imposed on drug manufacturers deterring global investors. Read More
South Korea’s antitrust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down on 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program. Read More
U.S. FDA drug approvals increased 19.18% compared to the first six months of last year, with June approvals up to 18 from the previous five months’ average of 14. Worldwide approvals are down 16.8% from the first half of 2022, but up 1.43% compared to the previous seven years’ average. Read More
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocity, Biogen, Bright Minds, Bond, Gannex, Geovax, Grifols, Harmony, Nanobiotix, Palvella, Perfuse, Pfizer, Sathgen, Vir. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Rad, Biorestorative, Botanix, Chroma, Cidara, Codexis, Fresh Trax, GSK, Hillstream, Idorsia, J&J, Limmatech, Minotaur, Omniab, Passage, Sangamo. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advent, Astria, Biophytis, Excision, Hutchmed, Ipsen, Junshi, Pharmala. Read More
