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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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A new trace-level silica analyzer for real-time monitoring of ultrapure water, steam and water chemistry can more accurately protect expensive components, including turbines and heat exchangers.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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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.
Following a Phase III failure and the departure of its CEO, Mirati Therapeutics is rumored to be engaged in acquisition discussions with French pharma giant Sanofi, according to Bloomberg.
After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call.
Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.
Data from a confirmatory study could not be reliably interpreted, according to the Oncologic Drugs Advisory Committee, which voted against Amgen’s request for full approval of its G12C KRAS inhibitor.