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Replimune Group Inc. announced that the U.S. Food and Drug Administration (FDA) has officially accepted its resubmitted Biologics License Application (BLA) for the investigational therapy RP1 for the treatment of advanced melanoma.

Replimune Group Inc. announced that the U.S. Food and Drug Administration (FDA) has officially accepted its resubmitted Biologics License Application (BLA) for the investigational therapy RP1 for the treatment of advanced melanoma.

老虎证券老虎证券2026/06/26 12:12
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This acceptance marks a critical step for the company in advancing the marketing process of this oncolytic virus immunotherapy. The FDA has set the Prescription Drug User Fee Act (PDUFA) target review date as December 25, 2024. The submission of this BLA is primarily based on key CERPASS clinical trial data, which evaluated the efficacy and safety of combining RP1 with the anti-PD-1 therapy librolizumab compared to using librolizumab alone in patients with advanced melanoma.
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Updated Version 3 - According to the Financial Times, McKesson and CD&R are close to reaching a deal worth more than $5 billion to acquire Option Care.

In the fifth paragraph, a quote from analyst Sahil Pandey was added. Reuters, October 5 - According to the Financial Times, citing informed sources, pharmaceutical distributor McKesson (MCK.N) and private equity firm Clayton Dubilier & Rice are about to reach an acquisition agreement to purchase infusion service provider Option Care Health, with the deal valued (including debt) at over 5 billions USD. After the report was published, Option Care's share price rose by 21% in after-hours trading. The report stated that the deal could be announced as early as Tuesday, but negotiations could still fall through. This potential acquisition would be McKesson’s latest move in expanding its healthcare services portfolio. In August this year, the company agreed to acquire Precision Medicine Group for about 2.25 billions USD (link), as part of its effort over the years to strengthen high-growth business sectors. Leerink Partners analyst Michael Cherny said the “strategic logic” of the deal makes sense, as it would expand McKesson’s business from physician offices to care settings in the home and alternative sites. Option Care provides infusion services that allow patients to receive intravenous treatments at home or other outpatient settings, eliminating the need to go to the hospital. McKesson has previously been restructuring its business portfolio by divesting non-core assets and investing in fields such as oncology and specialty care (link). Driven by the growth of its specialty distribution business and contributions from acquisitions, revenue for its oncology and multi-specialty business segment grew by 33% in the latest fiscal quarter. McKesson declined to comment, while CD&R and Option Care did not immediately respond to Reuters’ requests for comment regarding the report. (For non-English speakers' convenience, Reuters offers automated machine translations of its reports in several languages. As there may be mistakes in the automated translations or some context may not be included, Reuters does not guarantee the accuracy of the automated translation text, which is provided solely for readers’ convenience. Reuters bears no responsibility for any damages or losses caused by the use of automated translation functions.)

路透社•2026/10/05 21:18

Centalion acquires Hainesville natural gas assets from Silver Hill

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路透社•2026/10/05 20:41

McDonald's hit with class action alleging AI-powered menu price-fixing

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Reuters•2026/10/05 20:14
McDonald's hit with class action alleging AI-powered menu price-fixing