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The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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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.
The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
Despite the promise of its technology and funding from big backers, Tome Biosciences is “operating at reduced capacity” and weighing its “strategic options” as the Massachusetts-based company faces an uncertain future.