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While NK cell therapies can potentially avoid the serious side effects sometimes seen with CAR T cell therapies, experts say durability may stall their path to the market.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
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Moderna, Inc. announced that the first participant has been dosed in the Phase 2 study of the Company’s Omicron-specific bivalent booster candidate, which combines Moderna’s Omicron-specific booster candidate and the Moderna COVID-19 vaccine.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The agency’s briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.”
Citing a challenging macro environment, 2seventy bio is launching a sweeping strategic reorganization that will see 40% of its staff laid off and CEO Nick Leschly stepping down.
As the Novartis generics and biosimilars division nears its spin-off, Sandoz has signed a commercialization agreement with Samsung Bioepis, gaining rights to the latter’s Stelara biosimilar.
Following a $540 million IPO in May, Acelyrin’s lead candidate izokibep failed to meet the primary endpoint in a Phase IIb/III study of patients with the chronic inflammatory skin condition.
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
The collaboration, which includes an upfront payment of $120 million to Immatics, pairs Moderna’s mRNA technology with Immatics’ T-cell receptor platform for cancer treatment.
Following a Phase II review, Novartis has cut the development of a gene therapy candidate for geographic atrophy. In June, the company sold a dry eye disease drug to Bauch + Lomb for $1.75 billion.
The California pharma is building up to its first-ever approval with promising late-stage data for its once-daily investigational acromegaly pill paltusotine, an alternative to the injectable standard of care.
The first-in-class antibody-drug conjugate—in combination with Merck’s Keytruda—has shown promising results in a Phase II study of patients with metastatic non-small cell lung cancer.
After its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list, Astellas dismissed its Inflation Reduction Act lawsuit this week, while Illumina got new leadership.