Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tougher time outside the U.S. Europe’s Committee for Medicinal Products for Human Use (CHMP) has come out with a negative opinion on an MAA for treating KRAS G12C -mutated advanced non-small-cell lung cancer (NSCLC). Mirati said it disagrees with the ruling and plans on requesting a formal re-examination. The therapy was approved by the U.S. FDA in December 2022 for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior therapy. The ruling came with a flurry of positive CHMP opinions for companies including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos.

Long path finally leads to US approval of Daiichi Sankyo’s quizartinib in AML

Nearly five years after submitting its first NDA seeking U.S. approval for FLT3 inhibitor Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia, Daiichi Sankyo Co. Ltd. finally cleared the FDA hurdle, approved 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.

IPO reaps $80M for Turnstone’s oncology efforts

Turnstone Biologics Inc. raised about $80 million in an IPO, offering 6.7 million shares at $12 each. The company, which has reached the phase I stage, works with tumor-infiltrating lymphocytes meant to provide efficacy across most solid tumors. Turnstone is listing on the Nasdaq market under the ticker TSBX. Bofa Securities, Leerink Partners and Piper Sandler acted as joint bookrunners on the deal.

Branded drug price controls blamed for fall in U.K. pharma investment

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 drugs manufacturers deterring global investors.

Korea’s FTC slams GSK, domestic vaccine makers with $32M for price-fixing

South Korea’s anti-trust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program. The Fair Trade Commission (FTC) leveled the corrective order and financial penalties on vaccine manufacturer GSK plc and six domestic distributors and pharmaceutical firms, including Kwangdong Pharmaceutical Co. Ltd., GC Biopharma Corp., Yuhan Corp., Boryung Biopharma Co. Ltd., SK Discovery Co. Ltd. and Korea Vaccine Sales Co. Ltd. The charges pertained to anti-competitive price-fixing of 170 vaccine supply bids from February 2013 to October 2019.

US FDA approvals up, with two treatments for generalized myasthenia gravis among 18 approvals in June

U.S. FDA 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.

Kissei withdraws NDA for rovatirelin for spinocerebellar degeneration in Japan

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.

The BioWorld Insider Podcast: Biosimilars challenge to Humira revs up

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. While the competition started at the beginning of the year with the launch of Amgen’s Amjevita, the true test of the strength of the competition is taking place now as other adalimumab biosimilars hit the market. There are eight launching a challenge to Humira and all are likely to have a lower price tag than Humira’s. Discussing the biosimilars landscape with BioWorld Staff Writer Lee Landenberger are BioWorld Regulatory Editor Mari Serebrov, who has written extensively about biosimilars and these launches, and also Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, which recently released its second quarterly report on biosimilar market penetration and pricing across various therapeutic spaces.

Also in the news

Acelrx, Advent, Astria, Biocity, Biophytis, Biorestorative, Bright Minds, Bond, Cel-Sci, Chroma Medicine, Cidara, Codexis, Durect, Eisai, Evelo, Excision, Fresh Tracks, Gannex, Genelux, Geovax, Grifols, GSK, Harmony, Hillstream, Hutchmed, Idorsia, Immunitybio, Ipsen, Junshi, Lixte, Maplight, Molecure, Nanobiotix, Palvella, Passage, Perfuse, Pfizer, Pharmala, Promontory, Sagimet, Sangamo, Sathgen, Sight Sciences, Vir, Yarrow