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Following a lawsuit filed last week, Sage has officially rejected Biogen’s unsolicited buyout offer, which valued the embattled biotech at just $469 million.
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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
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.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive data from three retrospective real-world studies which demonstrated that initiation of Veklury® (remdesivir) within the first two days of hospital admission can help reduce mortality and hospital readmission rates among all patients hospitalized with COVID-19, regardless of disease severity.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Mirroring fellow pharmacy benefit manager CVS Caremark, Cigna’s Express Scripts is taking Humira off its major commercial formularies starting next year and focusing on more affordable biosimilar options.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
Belgium-based biopharma UCB is selling its Chinese neurology and allergy business to Singapore asset management firm CBC Group and Abu Dhabi investment company Mubadala.
The Switzerland layoffs are the latest in Bayer’s 2024 workforce reductions, which already include 1,500 people and nearly half of the executive leadership team.
MBX Biosciences follows Bicara Therapeutics and Zenas Biopharma, which also announced last week their respective plans to go public in a potential boost to the recent slump in the IPO market.
Tome Biosciences, a gene editing startup that launched in late 2023 with $213 million in funding, will eliminate 131 positions in November, according to a Worker Adjustment and Retraining Act notice.
Johnson & Johnson’s proposed changes to the hospital drug discount program are inconsistent with the federal statute, according to the Health Resources and Services Administration.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
Venture capital in the sector hit $9.2 billion in the second quarter of 2024, up from $7.4 billion in Q1, while exits fell on a slower M&A cycle and picky IPO market.
Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention.