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Roche doubles down with another subcutaneous FDA nod, this one for MS star OcrevusWhen Roche's Genentech gainedapprovalfor Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Nov2024/9/20
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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drugIt’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initial2024/9/18
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ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastasesDaiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the brain. The pa2024/9/18
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ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flopAs if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. From AZ’s p2024/9/13
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ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value from new cancer medsTwo of the simplest ways to measure the success of companies that develop and commercialize drugs is to count their approvals and sales. But a group of Harvard researchers has found another way to me2024/9/13
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ESMO: Despite positive trial, Merck's Welireg still comes up short in overall survivalOne year after reporting a split result on Merck’s Welireg in a key phase 3 trial, the song remains the same for the kidney cancer drug as it continues to show benefits in progression-free survival (2024/9/10
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Bavarian Nordic eyes external partnerships in bid to produce tens of millions of mpox vaccine dosesAs mpox continues to cause illness and claim lives in Africa, Bavarian Nordic is retooling certain vaccine supply pacts to ensure its vaccine goes to the regions that need it most. At the same time,2024/9/10
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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drugGilead Sciences is no stranger to making history in HIV. Twelve years after the drugmaker pushed the first pre-exposure prophylaxis (PrEP)HIV med, Truvada, over the FDA finish line, new results from2024/9/5
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Sanofi completes build out of $554M pandemic-ready modular plant for vaccines, biologicsAn ambitious project that was hatched during the coronavirus pandemic has hit a key milestone as Sanofi has completed construction of Modulus, a vaccine and biological medicine plant that can be quic2024/9/5
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Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing docFor Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. Ahead of an advisory committee meeting slated for Friday, the FDA on Wednesdayunleashed damningbriefi2024/9/3