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Clinical Trials & Development1 week agoESMO26: Lily’s sofe-m ADC stakes a claim in ovarian cancer
Eli Lilly's first major readout at ESMO comes from a phase 1 trial of its FRα-targeting sofe-m in platinum-sensitive ovarian cancer (PSOC).
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Clinical Trials & Development1 week agoESMO26: Lilly’s sofe-m ADC stakes a claim in ovarian cancer
Eli Lilly's first major readout at ESMO comes from a phase 1 trial of its FRα-targeting sofe-m in platinum-sensitive ovarian cancer (PSOC).
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Clinical Trials & Development1 week agoESMO26: BMS dual-acting ADC beats chemo in breast cancer
BMS and SystImmune's EGFRxHER3 bispecific ADC iza-bren has scored in another phase 3 trial, boosting its credentials as a future blockbuster.
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Regulatory Intelligence & Drug Approvals1 week agoAZ grabs FDA nod for Ultomiris in rare kidney disease IgAN
AstraZeneca has staked a claim to the increasingly crowded IgAN market with an accelerated approval from the FDA for Ultomiris, its fifth indication.
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Clinical Trials & Development1 week agoClinical trial setup times fall sharply in UK
Reforms to the regulatory framework for clinical research in the UK are starting to deliver, with delivery times down 35%, according to new data.
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Clinical Trials & Development2 weeks agoCagriSema helps women lose 25% of their weight in study
Novo continues to build the case for its new weight-loss candidate CagriSema, pointing to new data that show strong efficacy in women.
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Regulatory Intelligence & Drug Approvals2 weeks agoGSK wins FDA green light for chronic hep B treatment Hibsago
GSK's antisense-based drug for chronic hepatitis B virus (HBV) infection, Hibsago, has been approved in the US, its second major market after Japan.
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Regulatory Intelligence & Drug Approvals2 weeks agoCompounded tirzepatide recalled after FDA warning
A compounded version of Eli Lilly's injectable weight-loss and diabetes therapy tirzepatide has been recalled from sale due to sterility concerns.
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Regulatory Intelligence & Drug Approvals2 weeks agoJemperli label extended to include rectal cancer
GSK's PD-1 inhibitor Jemperli has been cleared by the FDA as the first pre-operative cancer immunotherapy for rectal cancer.
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AI, Machine Learning & Computational Biology2 weeks agoAI tool uses face photos to predict cancer survival
Researchers have developed an AI model, trained on millions of facial images, that can directly predict survival risk in patients with cancer.
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
