EMA validates Soleno’s application for Prader-Willi syndrome treatment
The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) submitted by Soleno Therapeutics for diazoxide choline prolonged-release …
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China’s CDE grants breakthrough status approval to Abbisko’s HCC therapy
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation approval to Abbisko …
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CHMP recommends GSK’s Blenrep approval for multiple myeloma treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSK’s Blenrep …
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Genentech to onshore US manufacturing amid rising drug pricing tensions
Genentech (San Francisco, CA) has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in Holly …
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ASCO25: Roche’s Itovebi combo reduces risk of death in breast cancer by 33%
Roche’s blockbuster vision for phosphoinositide 3-kinase (PI3K inhibitor) Itovebi (inavolisib) has been dealt a boost after the drug demonstrated further …
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NICE endorses CSL Vifor’s sparsentan for IgA nephropathy in adults
The UK's National Institute for Health and Care Excellence (NICE) has issued final draft guidance endorsing the use of CSL …
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Obesity therapies and the multi-indication momentum: how industry is responding
The obesity therapeutics market has gone from a standing start to the story of the year in biopharmaceuticals - and …
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Medicaid on a spit after Republicans’ budget bill passes House by single vote
The Trump administration’s budget reconciliation bill has passed the US House of Representatives by a wafer-thin single-vote majority. Passing the House …
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Bayer’s Eylea set for longer treatment intervals to challenge Roche’s Vabysmo
Bayer’s retinal disease treatment Eylea (aflibercept) is set for an extended treatment interval, a label extension that could give the …
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FDA approves GSK’s Nucala to treat COPD
GSK has gained approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab), as an …
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Aptar Digital to use AstraZeneca’s AI algorithms for CKD detection
Aptar Digital Health has signed a licensing agreement with AstraZeneca for detecting renal, cardiovascular and metabolic conditions such as chronic …
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Sanofi buys Vigil Neuroscience for $470m in Alzheimer’s push
Sanofi has agreed to acquire Vigil Neuroscience in a $470m deal, nearly a year after investing an initial $40m in …
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Paratek expands commercial portfolio with Optinose
Paratek Pharmaceuticals has completed the acquisition of Optinose, valued at almost $330m, broadening its commercial product offerings. The companies signed a …
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Wegovy and Zepbound costs capped at $200 in new Evernorth programme
Evernorth, the pharmacy benefits unit for health insurer giant Cigna, has reached a deal with drugmakers Novo Nordisk and Eli …
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Lilly’s Kisunla marketing for Alzheimer’s authorised in Australia
Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab) to treat …
