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While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
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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.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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.
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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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An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer’s disease.
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company’s schizophrenia drug, roluperidone.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
Milestone Pharmaceuticals reported highly positive data from its Phase III RAPID trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) patients.
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD).
Finding chemistry jobs in the life sciences industry doesn’t have to be difficult. Discover the top chemistry job options in the life sciences in our comprehensive guide.
Kineta struck a collaboration deal with Merck to pair its anti-VISTA monoclonal antibody with Keytruda (pembrolizumab) as a potential treatment for advanced solid tumors.
Gilead Sciences and MacroGenics entered into a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers.
NeuBase announced a strategic restructuring, diverting resources from its Huntington’s program and shedding 60% of its workforce.
SURGE Therapeutics announced $26 million in Series A financing to address surgery-induced immune suppression and prevent post-surgical cancer recurrence and metastasis.