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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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Advaxis and Ayala Pharmaceuticals entered a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer.
Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round.
Ambrx Biopharma Inc. announced it will lay off 15% of its workforce and suspend development of its lead candidate in a strategic realignment initiative.
Genetic engineering company Empyrean Neurosciences stepped into the CNS arena with $22 million and a small molecule platform derived from plants and fungi.
Salarius Pharmaceuticals voluntarily paused enrollment of its Phase I/II trial of seclidemstat for Ewing sarcoma and FET-rearranged sarcomas after a patient’s death.
GlaxoSmithKline (GSK) announced Tuesday morning it has struck a $70 million deal with Tempus in exchange for expanded access to Tempus’ AI-based patient data platform.
Ikena Oncology and AstraZeneca have entered into an agreement to evaluate Tagrisso (osimertinib) with Ikena’s IK-930 in EGFR-mutated non-small cell lung cancer.
Eli Lilly is acquiring precision medicine biotech Akouos for $487 million in cash in a deal focused on developing gene therapies for hearing loss.
As part of its third-quarter report, Roche announced it has cut two Phase II programs, one for hepatitis B and the other for geographic atrophy, a form of eye disease.
Mereo BioPharma will cut 40% of its headcount and significantly reduce expenses to support the advancement of its lead programs through the clinic.