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U.S. President Donald Trump’s announcement regarding new tariffs on pharmaceutical goods imported into the United States has been delayed. Despite the President’s threat early last week that a tariff disclosure would come “within the next week or so,” the much-anticipated announcement is now expected to be “weeks away,” according to a report from Reuters citing industry and government sources.
German CPTx GmbH, its CDMO Gxstrands, and the US start-up NanoCell Therapeutics have been awarded a Eurostars grant for their QUIET-CAR project, funded through the EU’s Horizon Europe programme and the Eureka Network. The focus of the project will be on the development of scalable in-vivo CAR-T therapies against cancer and autoimmune diseases.
Pilatus Biosciences AG, a Swiss biotechnology company headquartered in Epalinges with operations in the United States and South Korea, has entered into a clinical trial collaboration with Roche AG. As part of the agreement, Roche will provide its PD-L1 immune checkpoint inhibitor atezolizumab for use in a Phase I study evaluating the combination of atezolizumab with Pilatus’s investigational CD36 inhibitor, PLT012, in patients with hepatocellular carcinoma (HCC).
Bayer AG’s Pharmaceuticals division in Berlin has expanded its oncology pipeline through a licensing and collaboration agreement with US-based Kumquat Biosciences Inc., which may yield up to US$1.3bn in total consideration. Should Kumquat successfully complete its high-risk Phase Ia clinical study targeting the common KRAS G12D mutation, Bayer will assume responsibility for further development and global commercialisation of the candidate.
IO Biotech has published top-line results from its pivotal Phase 3 trial evaluating the therapeutic cancer vaccine IO102-IO103 (Cylembio) in combination with pembrolizumab in patients with advanced melanoma. While the combination achieved a notable improvement in progression-free survival (PFS), the study narrowly missed its predefined statistical threshold for significance.
Novartis AG has reported a clinical milestone in the treatment of Sjögren’s syndrome, with its BAFF receptor blocker Ianalumab (VAY736) becoming the first investigational therapy to demonstrate a statistically significant reduction in disease activity in pivotal Phase III trials, as measured by the ESSDAI score.
Dewpoint Therapeutics Inc. has announced a significant corporate restructuring. Approximately 70% of its 130 employees will be laid off, and operations will be consolidated at the company’s Boston headquarters. The company will close its two German locations in Frankfurt and Dresden and streamline its pipeline.
The European Commission has launched a public consultation to support the development of the European Biotech Act, which is now being prioritised after a previous delay. The Commission plans to publish the legislative proposal by the end of 2025 and is inviting stakeholders across the biotechnology sector to provide feedback on regulatory, financial, and operational barriers.
Italian biotech company ReiThera srl has commenced safety trials of its experimental HIV vaccine candidate, GRAdHIVNE1, in Harare, Zimbabwe. Developed in partnership with the Ragon Institute at Harvard University, this innovative HIV vaccine targets conserved regions of the viral gag, env, and pol genes to stimulate a robust cytotoxic T-cell immune response.
Initial clinical data indicate that the recombinant cysteine protease imlifidase, developed by Hansa Biopharma AB, may significantly reduce levels of anti-AAV antibodies, potentially enabling adeno-associated virus (AAV)-based gene therapies in patients previously deemed ineligible due to pre-existing immunity.