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With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins.
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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.
New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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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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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.
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.