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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.
Following its recent about-face on the BIOSECURE Act, designed to combat China’s influence in the biopharma industry, lobbying group Biotechnology Innovation Organization in a realignment is laying off 30 employees.
The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.
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.
Seladelpar, which Gilead acquired when it bought CymaBay in February for $4.3 billion, showed positive results for reducing pruritus in primary biliary cholangitis patients and reducing inflammation.
Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.
To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.
The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.