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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.
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Read our takes on the biggest stories happening in the industry.
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
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Eli Lilly first linked up with Gate Bioscience in July 2025 to leverage the biotech’s “Molecular Gate” engine to treat diseases with high unmet need. Monday’s expansion will add one undisclosed target to the existing agreement, with an option for a second.
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.
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.
Jefferies analysts made the prediction after Sarepta Therapeutics, which has endured nothing short of a saga with the Duchenne muscular dystrophy gene therapy Elevidys, presented data this week showing its clinically meaningful benefit in older patients who are able to walk.
Capitalizing on space’s microgravity, the United Therapeutics–partnered Varda Space Industries aims to make medicines with better bioavailability and stability than Earth-produced molecules.
Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.