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FDA
Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
IPO
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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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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At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.
Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.
FDA
The Swiss pharma continues its winning streak with the FDA’s approval of the intravenous formulation of Cosentyx for ankylosing spondylitis, axial spondyloarthritis and psoriatic arthritis.
Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio.
In BioSpace’s latest webinar, we covered topics including proactive recruitment strategies, remote hiring, compensation negotiating and employee retention.
In this webinar, we discuss how to create policies that are fair for both remote and local workers; vaccination policies; travel policies; communication strategies and managing employee relations in regards to these changes.
BioSpace was thrilled to host a virtual panel discussion to hear how workplaces can improve their D&I strategies and help organizations thrive. We heard insightful advice from panelists from Amgen, Intellia Therapeutics, Obsidian Therapeutics, Omega Therapeutics and Athira Pharma.
BioSpace was delighted to host a virtual panel discussion to hear how workplaces can prepare for a return to the office, and how to approach new policies related to Covid-19, mental health support, remote work culture, and more. This was a thoughtful discussion with insights from CalciMedica, Sutro Biopharma, Affinity Empowering, Axogen and Chiasma.
How can life science workplaces improve not only diversity but create enduring inclusivity that not only empowers employees but fosters a culture of success and mutual trust?
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.