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BioSpace
1 小时
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...
BioSpace
1 小时
Denali Suffers Another ALS Fail With Phase II/III Flop
Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and ...
BioSpace
16 小时
Higher Biopharma M&A Activity ‘Almost Inevitable’ in 2025, With Viking as Top Candidate ...
Seeking Alpha analyst Terry Chrisomalis regards Viking Therapeutics as the most attractive M&A candidate in 2025, bolstered ...
BioSpace
22 小时
Novo Launches Citizen Petition to Block Compounded Victoza
In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, ...
BioSpace
22 小时
Merck Snaps Up WuXi Biologics Facility in Ireland for $500M
The acquisition from Wuxi Biologics, the embattled CDMO named in the BIOSECURE Act, marks another expansion of Merck’s ...
BioSpace
1 天
All About Speed: Lilly Drives Innovation With New Facility to Help Bring Medicines to Market
Eli Lilly and Company has invested more than $20 billion in its manufacturing capabilities since 2020 to help meet high ...
BioSpace
1 天
Novo-Backed Oral Medicine Biotech Adds Lilly to Investors in $93M Series A
Orbis emerged from stealth in February 2024 with $28.1 million in seed funding. The Danish biotech, which aims to flip ...
Opinion
BioSpace
1 天
Opinion
Opinion: The Cocktail Recipe That Will Cure Alzheimer’s
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of ...
BioSpace
1 天
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
BioSpace
1 天
Biopharma Heads to JP Morgan Seeking an M&A Spark to Improve Sentiment
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next ...
BioSpace
4 天
Roche Kicks Off 2025 Committing a Potential $1B for Another ADC From China
Roche has once again returned to China to bolster its antibody-drug conjugate pipeline, this time striking a licensing deal ...
BioSpace
4 天
Axsome Posts Mixed Phase III Data in Alzheimer’s Agitation, Plans FDA Filing
With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval ...
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