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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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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.
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.