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This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.
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Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
Following a series of clinical failures, optimism builds for the first disease-modifying treatment.
Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?
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Moderna, Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Spikevax, its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.
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Read our takes on the biggest stories happening in the industry.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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Orbis emerged from stealth in February 2024 with $28.1 million in seed funding. The Danish biotech, which aims to flip biologics into oral medicines, has now raised another $93 million.
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
Expanding volumes of data point to mechanisms beyond weight loss and blood sugar control that contribute to cardiovascular benefits in the world’s fastest-growing drug class.
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Novo Nordisk’s GLP-1s outsell Eli Lilly’s thanks to its superior marketing. Here’s how.
Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval in the second half of 2025.