FDA’s revolving door reveals Pazdur as new CDER head
The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking …
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Sophia Genetics and Element partner to advance precision medicine research
Sophia Genetics and Element Biosciences have teamed up to advance genomic sequencing and workflows for precision medicine. Announced during the Association …
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UK invests £60m to phase out animal testing in preclinical trials
The UK Government is investing £60m ($78.76m) to push pharma and biotech to use alternative preclinical models in a pull …
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Pathkey and Armstrong Clinical collaborate to advance AI-powered trial design
Pathkey has entered a master collaboration agreement (MCA) with Armstrong Clinical, a clinical development consultancy in Melbourne, Australia. This partnership aims …
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Ariceum Therapeutics doses first patient for SANTANA-225 trial for MCC and ES-SCLC
Ariceum Therapeutics has announced the dosing of first patient in the SANTANA-225 Phase I/II clinical trial for 225Ac-SSO110, a treatment …
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Pathkey and Armstrong Clinical collaborate to advance AI-powered trial design
Pathkey has entered a master collaboration agreement (MCA) with Armstrong Clinical, a clinical development consultancy in Melbourne, Australia. This partnership aims …
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Ariceum Therapeutics doses first patient for SANTANA-225 trial for MCC and ES-SCLC
Ariceum Therapeutics has announced the dosing of first patient in the SANTANA-225 Phase I/II clinical trial for 225Ac-SSO110, a treatment …
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Roche sizes up first BTK inhibitor approval on Phase III MS victory
Roche is eyeing regulatory approval for its oral multiple sclerosis (MS) hopeful, fenebrutinib, after the drug met its primary endpoints …
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Sharp Services invests $100 million in US and European facilities to increase capacity and service offerings
Sharp Services, a leader in pharmaceutical packaging, clinical trial services and sterile manufacturing has announced a $100 million investment across its …
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AHA 2025: SHR-1918’s impact on hyperlipidaemia through angiopoietin-like 3 inhibition
On 10 October, at the American Heart Association (AHA) 2025 conference in New Orleans, Louisiana, US, during a late-breaking session …
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enGene’s NMIBC gene therapy touts 63% complete response in pivotal trial
enGene’s gene therapy for high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) has touted a 63% complete response (CR) …
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Physical activity effects mortality risk in epilepsy
Exercise has traditionally been associated with better health outcomes. According to the World Health Organization, there are various physical and …
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Simcere’s SIM0278 enters Phase II trial in China for atopic dermatitis
Simcere Pharmaceutical’s IL-2 mutant fusion protein (IL-2 mu-Fc), SIM0278, has entered a Phase II trial in China, for moderate-to-severe atopic …
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Cogent’s stock soars on Phase III gastrointestinal cancer data
Cogent Biosciences' stock has soared after its lead asset, bezuclastinib plus sunitinib, outperformed sunitinib alone in a pivotal gastrointestinal cancer …
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Neurocrine’s depression treatment misses main goal in Phase II study
Neurocrine Biosciences has reported that its Phase II trial assessing NBI-1070770 in the adult population with major depressive disorder (MDD) …
