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The Boston-area company’s previous raises were also aimed at getting its investigational antibody treatment for inclusion body myositis through clinical trials. Now, Abcuro is eyeing a regulatory submission and potential launch.
FEATURED STORIES
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
Sheila Gujrathi, former CEO of Gossamer Bio, has written a new book that aims to offer the type of leadership manual she never had in her early career.
The startup, launched out of CEO Kevin Parker’s grad school idyll during the COVID lockdowns, is primed to find new targets where Big Pharmas won’t dare.
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Illumina announced that based on the preliminary results of its 2023 Annual Meeting, Illumina shareholders have voted to elect eight of nine Illumina director nominees – Francis deSouza, Robert Epstein, MD, Frances Arnold, PhD, Caroline Dorsa, Scott Gottlieb, MD, Gary Guthart, PhD, Philip Schiller, and Sue Siegel, as well as Andrew Teno, to the Board of Directors.
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Read our takes on the biggest stories happening in the industry.
After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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The overall survival data from the late-stage trial will help Pfizer in its bid to expand the label for Talzenna and Xtandi, potentially covering all patients with metastatic castration-resistant prostate cancer regardless of biomarker status.
The pediatric patients, with a rare neurodegenerative disease, were treated with bluebird bio’s Skysona to slow the progression of neurologic dysfunction. Six patients developed myelodysplastic syndrome and one patient developed acute myeloid leukemia.
The settlement, which is at the low end of Jefferies analysts’ $2 billion to $3.5 billion estimate, will resolve 93% of the product liability cases regarding allegations that GSK’s heartburn drug could cause cancer. Analysts say separate concerns remain about its vaccines business.
Carlos Doti has moved countries and changed jobs, but one thing hasn’t changed. Making an impact on patient care has always been a priority for the AstraZeneca executive.
M&A
After four patient deaths, Kezar’s lupus trial is officially on hold, sparking investor Kevin Tang’s interest for acquisition.
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
In a departure from most deals, startup insitro will in-license Lilly’s delivery technology for its investigational liver-targeted siRNA therapies. The pharma will be eligible for milestones and royalties down the line.
Managers face a variety of challenges during their careers. Instead of falling into fight or flight, develop resilience to navigate the uncertain moments that pop up from time to time.
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had deficiencies.