Featured Story | By Nick Paul Taylor Gilead’s $4.9 billion oncology bet has hit a late-phase setback. Spooked by an “apparent imbalance” in adverse reactions between study arms, the FDA has imposed a partial clinical hold on a handful of trials of magrolimab—raising questions about the program and the billions biopharma has bet on CD47. read more |
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Top Stories By Annalee Armstrong CytoDyn CEO Nader Pourhassan, Ph.D., is out, and CFO Antonio Migliarese is in, at least for the interim, in the latest twist in one of the wildest tales in biotech. The embattled company, which has been trying for the past year to prove its therapy leronlimab can work in diseases from cancer to COVID-19 to HIV, unveiled the leadership change Tuesday morning. read more By Nick Paul Taylor The follicular lymphoma market is thinning out fast. Days after Gilead pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies. read more By Kyle LaHucik The FDA has stopped Cortexyme from studying its lead drug atuzaginstat any further in Alzheimer's and other conditions, dealing a blow to the pipeline and sending shares cratering 30% Wednesday morning. The biotech will now have to focus on its second bet at treating the neurodegenerative disease. read more By Kyle LaHucik Ziopharm Oncology will start trading as Alaunos Therapeutics on Thursday as the biotech rebrands after a rocky 2021. read more By Annalee Armstrong Gilead has tagged along on Kyverna Therapeutics’ journey as a startup since the beginning, and now the Big Pharma has helped stock up the cell therapy biotech in an $85 million financing round to prepare for a launch into the clinic this year. read more By Angus Liu Pancreatic cancer is one of the most aggressive tumor types with few effective treatment options. Now, a team of scientists has provided new insights into how targeting a common type of cells could have conflicting implications in treating the devastating disease. read more By Fraiser Kansteiner The FDA has given Lilly a slap on the wrist for an Instagram post about its top-selling diabetes med, Trulicity, STAT News first reported. This marks the second round of advertising trouble since December for the Indianapolis-based drugmaker. That prior entanglement was over TV spots for Lilly's migraine treatment Emgality and was quickly resolved. read more By Eric Sagonowsky For an upcoming special report, Fierce will profile the 20 most influential people in the industry—both in the fight against the pandemic and those who are setting the stage for the industry’s advances for years to come. read more By Paige Minemyer Anthem reported $1.1 billion in profit for the fourth quarter, doubling its haul of $551 million in the fourth quarter of 2020. read more By Andrea Park Less than two years after scoring its first FDA clearance, Akili Interactive is betting big on its digital therapeutic technology. read more By Joseph Keenan Clarify Health, a healthcare and life sciences research analytics group, has launched its Clarify Trials software designed to improve the recruitment of clinical trial participants from underserved communities. read more By Joseph Keenan TriNetX, which focuses on real-world research to help develop new therapies, acquired pharmacovigilance software maker Advera Health Analytics for an undisclosed price. read more Resources Sponsored by: WIRB-Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. 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Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. 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