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Red light, green light: England's NICE not sold on Lilly's Kisunla despite UK approvalEli Lilly’s Alzheimer’s disease offering Kinsunla is poised to face a tough road ahead in the U.K. While the region’s Medicines and Healthcare products Regulatory Agency (MHRA) signed off on an appro2024/10/17
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Roche's Vabysmo will rise above Eylea biosim threat, exec says, as DMD gene therapy Elevidys delivers sales surpriseBy squeezing Regeneron’s Eylea, eye disease drug Vabysmo has become one of the biggest growth drivers for Roche. But will the potential imminent launch of a copycat to Eylea stifle Vabysmo’s market e2024/10/22
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Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutideThe war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent2024/10/22
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In boon for Pfizer and Merck, CDC panel backs expanded use of pneumococcal vaccinesWith an expanded usage recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines from Pfizer and Merck are poised to add millions more eligibl2024/10/25
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GSK answers Pfizer's RSV approval with data targeting matching nod in younger adultsPreliminary results from two trials showed that GSK’s respiratory syncytial virus (RSV) vaccine Arexvyhas potentialin younger adults with certain risk factors, potentially positioning the shot for a2024/10/25
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ESMO: Merck unpacks a mixed bag of gynecological cancer results for KeytrudaEven for Merck’s oncology powerhouse Keytruda, the emerging role of immunotherapies in gynecological cancer treatment represents a bit of a mixed bag. While earlier this year Keytruda seemed to shine2024/9/20
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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