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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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In a strategic reorganization announced Thursday, Axcella Therapeutics will focus its resources on its Long COVID program and slash headcount by 85%.
While showing early promise, Senolytics is a new field and most of the research is still in academic centers – most notably, the Mayo Clinic.
Vertex is kicking off a Phase I trial assessing VX-522, an mRNA therapy designed to treat the underlying cause of cystic fibrosis lung disease, while SpliSense is targeting a specific mutation.
Kymera and Sanofi shared positive results for an IRAK4 degrader for hidradenitis suppurativa and atopic dermatitis.
The past two years have seen a considerable shift towards remote work, but now that the pandemic is waning, BioSpace has compiled relevant data on remote work to see if it’s here to stay.
Shares of Avidity Biosciences are soaring following reported early signs of clinical activity and improvement in patients with myotonic dystrophy type 1 (DM1) treated with its RNA-based therapeutic.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
See inside for BioSpace’s compilation of the five biggest M&A deals of 2022.
In a comparison trial, BeiGene’s Brukinsa bested Janssen’s Imbruvica in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Flagship Pioneering has committed $50 million to Montai Health, a biotech that aims to develop therapies for chronic diseases using molecules already found in nature.