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AI is quickly becoming a central force in drug development, from powering pharma engines to permanently rewiring the capital markets.
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.
Three years after Qalsody was approved by the FDA as the first drug to target a genetic cause of ALS, some patients are reporting not only disease stabilization but also improvement of symptoms.
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The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
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Mereo BioPharma’s asset, dubbed alvelestat, is set to enter Phase 3 development for AATD-LD in 2027.
BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra.
After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
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.
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.