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521,499 Results for "genkyotex s a".
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Regulatory
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause.
January 22, 2025
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2 min read
·
Tristan Manalac
Calliditas announces acquisition of remaining Genkyotex minority shares
Calliditas Therapeutics AB announced that the company now controls 100% of the share capital of Genkyotex SA, after the completion of a centralized squeeze out offer to all minority shareholders.
October 7, 2021
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4 min read
Podcast
BridgeBio’s ATTR-CM Approval, Cassava’s Alzheimer’s Failure, Trump’s Cabinet Picks, More
BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue.
November 27, 2024
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1 min read
·
Heather McKenzie
NextGen
BioSpace
’s NextGen Class of 2025 Leans Into Biopharma’s Hottest Trends
From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.
January 7, 2025
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4 min read
·
Heather McKenzie
Parkinson’s disease
Roche’s Prothena-Partnered Parkinson’s Drug Fails Mid-Stage Trial
The report comes just two days after Novartis announced its own Parkinson’s drug failure.
December 19, 2024
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1 min read
·
Annalee Armstrong
Business
Dispatches From JPM, Biogen’s Sage Buyout Offer, Pfizer’s Obesity Play, More
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
January 15, 2025
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1 min read
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Heather McKenzie
CAR-T
Gilead/Arcellx’s Anito-Cel’s Differentiated Safety Profile Challenges J&J/Legend’s Carvykti
Anito-cel has shown no signs of delayed neurotoxicity at around 9 months of follow-up, hinting at a safety profile that could set it apart from J&J and Legend’s Carvykti.
December 10, 2024
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2 min read
·
Tristan Manalac
Accelerated approval
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
January 15, 2025
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2 min read
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Tristan Manalac
Drug shortages
Legal Challenge Over Lilly’s GLP-1 Shortages Highlights FDA’s Post-Chevron Vulnerability
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
November 26, 2024
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4 min read
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Ben Hargreaves
Neurodegenerative disease
7 Alzheimer’s and Parkinson’s Programs Discarded in 2024
This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets.
November 4, 2024
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6 min read
·
Heather McKenzie
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