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ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns.
Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
Insilico Medicine CEO Alex Zhavoronkov’s mad dash across the BIO International Convention in June attracted plenty of eyes. But the executive would prefer industry watchers gawk at the billions of dollars’ worth of deals his company has struck.
Epicrispr Biotechnologies is working on an epigenetic medicine for facioscapulohumeral muscular dystrophy, while Infinimmune will advance a pair of antibodies for atopic dermatitis.
AbCellera Biologics’ reduction in hot flashes sets it apart from currently commercial oral drugs, including Astellas’ Veozah and Bayer’s Lynkuet, according to BMO Capital Markets.
The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Takeda, Agios and Disc Medicine.
Vaderis is hoping that engasertib will become the first approved medicine for hereditary hemorrhagic telangiectasia, a rare condition that can cause spontaneous bleeding.
The national growth vehicle isn’t biotech‑dedicated, but channeling capital toward life sciences would amplify Austria’s strong research hubs, nondilutive funding landscape and reputation as a champion in science and technology.
Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing.
A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.