Clinical Trials
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Approvals
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Total approvals
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- Intravacc and Primrose Bio have renewed their strategic partnership to enhance conjugate vaccine development and manufacturing capabilities for third-party clients. - The collaboration combines Intravacc's expertise in vaccine conjugation and GMP production with Primrose Bio's PeliCRM197® carrier protein technology. - The partnership creates a seamless full-service solution spanning from early-stage development through clinical manufacturing for vaccine developers. - PeliCRM197® represents the only CRM197 carrier protein used in commercial vaccines that is available for purchase, offered in research and GMP grades.
- Alvotech founder Róbert Wessman will transition from CEO to Executive Chairman at the end of Q1 2026, continuing in a full-time capacity focused on strategy and business development. - Lisa Graver, former CEO of Alvogen and current Alvotech board member, has been appointed as the new Chief Executive Officer following a planned succession process. - The leadership transition comes as Alvotech operates with five biosimilars on the global market and maintains a pipeline of 30 products in development targeting autoimmune disorders, cancer, and other therapeutic areas. - Graver brings over 25 years of pharmaceutical leadership experience and has worked closely with Wessman for more than two decades across specialized generics and biosimilar sectors.
- NRx Pharmaceuticals completed enrollment of 74 patients in its Phase 2b/3 trial of NRX-101, a combination of D-cycloserine and lurasidone for treating suicidal treatment-resistant bipolar depression. - The trial demonstrated NRX-101 achieved a 58% relative reduction in time to sustained suicidality remission compared to lurasidone alone, with statistical significance when stratified by key patient factors. - NRX-101 showed a 76% reduction in akathisia symptoms versus lurasidone, with only 2% of patients experiencing akathisia compared to 11% on lurasidone monotherapy. - The drug has received FDA Breakthrough Therapy Designation and could become the first antidepressant approved to reduce suicidality in bipolar depression, addressing an unmet need in 7 million US patients.
