Despite Health and Human Services Secretary Robert Kennedy’s oft-repeated vow to rid the FDA of industry influence, FDA Commissioner Marty Makary announced George Tidmarsh, an industry veteran, will be the next director of the agency’s Center for Drug Evaluation and Research (CDER).
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
Big pharma is increasingly shopping in China to fill its pipelines as it faces looming patent cliffs on major blockbusters coupled with growing pricing pressures on drugs. China’s out-licensing deals grew to represent 32% of global deals in the first half of 2025, according to a Jefferies report on China dealmaking.
Expanding on guidance issued a dozen years ago, the U.S. FDA released a draft guidance to help sponsors developing cancer drugs for use in novel combinations determine the contribution of the individual drugs’ effect.
Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
Sino Biopharmaceutical Ltd. agreed to fully acquire Lanova Medicines Ltd. by buying an additional 95.09% stake in Lanova at a valuation of up to $950.92 million. Considering Lanova’s estimated cash and deposit of $450 million, Hong Kong-headquartered Sino agreed to pay $500.9 million to Lanova on the date of the transaction, set to close within 30 days of all conditions being satisfied, or July 31, 2025.
Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate.
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
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