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After a series of clinical-stage failures, Alector is resetting around its preclinical blood-brain barrier delivery technology, securing a big pharma partnership along the way.
CSL will co-develop and co-promote Alentis Therapeutics’ anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune disease characterized by small blood vessel inflammation.
All signs continue to point forward for Biogen’s initial foray into lupus, as litifilimab elicited clear or almost clear skin within one year in patients with cutaneous lupus in a mid-stage study. Data from two Phase 3 studies of systemic lupus are expected by the end of the year.
VAX-31 beat Pfizer and Merck’s established pneumococcal conjugate vaccines in a Phase 3 trial, exceeding investors’ most ambitious scenario and setting Vaxcyte up to challenge the Big Pharmas in a market worth $8 billion.
Not a month after reports of three deaths in autoimmune trials for Novartis’ CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.
CEO Matt Gline is juggling Roivant Sciences’ first solo drug launch and several maturing programs as the hub-and-spoke company sets its sights on a massive turning point into commercial viability.
The FDA has taken important steps through Operation TrialBlazer and stronger scrutiny of foreign clinical data, but more must be done to make the United States more competitive in attracting clinical trials as China’s capabilities rise.
A surge of consolidation, rising appetite for specialized manufacturing and a shift toward decentralized trials is reshaping Switzerland’s life sciences landscape. From peptide producers to organoid CROs, service providers are scaling and diversifying as global sponsors turn to Swiss hubs for talent, innovation and regulatory strength.
BMO Capital Markets is more impressed by Merck’s plans to replace lost Keytruda revenue than on Bristol Myers Squibb’s efforts to fill the expected void that will come from loss of exclusivity for both Opdivo and Eliquis.
Follow along as BioSpace tracks job cuts and restructuring initiatives.