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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Pfizer Reports Positive Phase III Results for RSV Vaccine Abrysvo in Younger Adults
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Pfizer (NYSE: PFE) has announced interim results from a Phase III trial evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease (LRTD). Currently, the vaccine is approved for preventing RSV-associated LRTD in older adults and for…
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Boehringer Ingelheim’s Shanghai Unit Secures EMA and FDA Approval for Biopharmaceutical Supply
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Germany-based Boehringer Ingelheim has announced that its Shanghai-based Contract Manufacturing Organization (CMO), Boehringer Ingelheim Biopharmaceuticals China (BioChina), has successfully passed pre-approval inspections conducted by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). This approval allows its customer to supply biopharmaceuticals to the EU and…
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Sanofi Extends Collaboration with Nurix Therapeutics, Targeting STAT6 in Type 2 Inflammation
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France’s Sanofi (NASDAQ: SNY) has announced an extension of its 2019 collaboration with Nurix Therapeutics (NASDAQ: NRIX), a leader in targeted protein degradation, focusing on the drug target STAT6 for type 2 inflammation. The partners anticipate identifying a clinical candidate within the next year. As part of the collaboration, Nurix…
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Genesis MedTech Secures Hundreds of Millions in Funding to Boost R&D and Manufacturing in China
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Singapore-based medical device company Genesis MedTech has raised “hundreds of millions” of renminbi in a recent financing round co-led by Wuxi Capital Group and Wuxi Binhu Industrial Investment and Development, alongside a prominent U.S. medical device firm. The funding will support product research and development at its Wuxi facility, as…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Novartis Announces Layoffs to Streamline Operations and Boost Portfolio Value
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is gearing up for a strategic restructuring that will result in the layoff of up to 680 staff members across its Swiss and US development teams. This move, reported by Endpoints News, comes on the heels of similar announcements from industry peers Bayer (ETR:…
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Merck Sharp & Dohme Acquires Abceutics for Next-Generation ADC Technology
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Global healthcare leader Merck, Sharp & Dohme (MSD) (NYSE: MRK) has secured a strategic acquisition of Abceutics, a preclinical biopharmaceutical startup focused on optimizing antibody-drug conjugates (ADCs). The financial details of the transaction remain undisclosed. Abceutics has developed a series of payload-binding selectivity enhancers (PBSEs) designed to increase the safety…
