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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.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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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AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.
If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.
After being spun off of sequencing giant Illumina, Grail on Tuesday is set to start trading on the Nasdaq Global Select Market following a years-long antitrust battle with regulators.
Merck KGaA’s drug candidate xevinapant in a late-stage trial was unable to significantly improve event-free survival in patients with locally advanced head and neck cancer.
Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina.
Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.
The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
G1 Therapeutics on Monday reported Phase III study results showing its drug Cosela did not demonstrate a statistically significant effect in overall survival in triple-negative breast cancer patients.
Alnylam’s Amvuttra reduced the risk of all-cause death or recurrent cardiovascular events by at least 28% in patients with transthyretin amyloidosis with cardiomyopathy, the company announced Monday.
Data showed that Eli Lilly’s Zepbound could resolve obstructive sleep apnea in at least 43% of patients, solidifying the pharma’s case for label expansion.