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The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth.
Johnson & Johnson has been fighting thousands of lawsuits over its now-discontinued talc products for 16 years. A pending judge’s ruling could finally put the issue to bed once and for all.
Analysts acknowledged the long-term manufacturing deal could dull Viking’s takeout prospects but hailed it as a smart move to ensure supply.
Vepdegestrant did not improve progression-free survival broadly but saw improvements in one specific patient cohort. Arvinas’ stock took a 43% tumble on the news, and analysts are downcast on the drug’s prospects.
As we reflect on five years of COVID-19, it’s clear that the impacts are still unfolding. The life sciences—and we as individuals—will never be the same again.
Roche acquired Spark Therapeutics in 2019 for $4.8 billion.
BEAM-302 “has set the bar for efficacy in this space,” William Blair analysts wrote in an investor note on Monday.
Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement.
While there are benefits of having employees on-site, the limited workplace flexibility at some companies following the COVID-19 pandemic can affect not only employees but also organizations’ retention and attraction efforts.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.