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BioSpace
12 小时
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...
BioSpace
12 小时
Sarepta, Biotech’s Regulatory Go-Getter, Signs Standout Rare Disease Deal
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead ...
BioSpace
12 小时
Amylin Commands Weight-Loss Attention as Industry Anticipates Novo’s Phase III CagriSema ...
Amylin analogs present a strong alternative or complement to GLP-1 receptor agonists, potentially eliciting higher-quality ...
BioSpace
10 小时
Lilly Claims Key Weight Loss Victory Over Novo in Head-to-Head Study
SURMOUNT-5’s results reflect those of multiple real-world studies, which have found that tirzepatide treatment results in ...
BioSpace
9 小时
Trump Administration a Mixed Bag for Biopharma
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S.
BioSpace
12 小时
Biopharma’s Shopping Spree, Applied Crashes on Rejection, Skysona’s Safety Concerns, More
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, ...
BioSpace
1 天
Takeda Puts Up to $1.3B on the Line for Keros’ Blood Cancer Anemia Drug
Keros’ elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a ...
BioSpace
1 天
Roche Partners With COUR in Autoimmune Deal Potentially Worth More Than $900M
The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to ...
BioSpace
1 天
Gilead Plots ADC Comeback With Potential $415M License Agreement
The deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder ...
BioSpace
1 天
Intra-Cellular Eyes Depression Approval for Caplyta as Stock Flies Under the Radar
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening ...
BioSpace
1 天
Alligator Axes 70% of Staff Amid ‘Capital Constraints,’ Renews Pancreatic Cancer Focus
Alongside the layoffs, Alligator will also suspend work on all of its earlier-stage assets and devote its resources to lead ...
BioSpace
2 天
Bluebird’s Gene Therapy Skysona Under FDA Safety Probe for Hematologic Malignancies
The FDA last week announced that it is looking into the safety of bluebird bio ’s gene therapy Skysona (elivaldogene ...
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