Drug Development

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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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Data presented at the ASCO meeting this weekend show that treatment with Enhertu demonstrated a 49% improvement in median overall survival by more than six months.
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity.
Gilead Sciences shared what seemed to be good news regarding Trodelvy in HR+/HER2- breast cancer at the 2022 American Society of Clinical Oncology’s annual meeting.
Well-known for its neurological drug development programs, Alkermes has firmly planted its flag as an oncology company at ASCO. Alkermes Head of Oncology Jessicca Rege spoke with BioSpace.
Primary seven-year data from Janssen’s (Johnson & Johnson) Phase III trial of Imbruvica (ibrutinib) in lymphoma demonstrated positive survival outcomes.
It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
The results showed that insulin icodec is as non-inferior to Sanofi’s insulin glargine, Lantus, potentially bringing another major competitor into the insulin space.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax’s COVID-19 vaccine.