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Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Ahead of an FDA decision in the third quarter, Regeneron is touting promising durability data from the Phase III PULSAR trial for higher-dose Eylea in patients with wet age-related macular degeneration.
After reaching a settlement with Thermo Fisher earlier this month, the family of Henrietta Lacks is now suing Ultragenyx for its “unjust enrichment” using their matriarch’s immortal cell line.
Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
The Supreme Court of the United States has granted the Department of Justice’s motion for a stay regarding Purdue’s bankruptcy case and is set to assess the legality of the settlement in December.
At AAIC, researchers presented studies using CRISPR-Cas9 in animal/organoid models of Alzheimer’s disease, but some experts doubt that such approaches will successfully translate to humans.
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
Amid record sales of its obesity treatment Wegovy, as well as diabetes drugs Ozempic and Rybelsus, Novo is buying Canadian biotech Inversago Pharma to further boost its weight-loss pipeline.
Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
The company has lowered its 2023 guidance amid leadership changes and antitrust scrutiny. Illumina now expects a 1% increase in revenue, down from its previous 7% to 10% growth forecast.