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The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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Read our takes on the biggest stories happening in the industry.
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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A failed rare disease clinical trial brings social media expertise to the pharma industry and patient recruitment: A discussion with Bryan Manning, founder of Clinical Enrollment and Two Blind Brothers
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.
Activist hedge fund investor Elliott Investment Management has bought over a $1 billion stake in BioMarin as the biotech grapples with a leadership change and disappointing sales of its hemophilia A gene therapy.
Newer hiring models based on skills applicants have learned and their general potential for growth could avoid the drawbacks of relying on degrees and experience.
A combination of Gilead Sciences’ domvanalimab and Arcus Biosciences’ zimberelimab, along with chemo, has shown an “encouraging” overall response rate in a mid-stage study.
Although it hit primary and secondary endpoints in a Phase II study, Ventyx Biosciences concluded that the results weren’t strong enough to face the stiff competition for the indication.
BioSpace has published its annual 2024 Best Places to Work list.
For $80 million upfront and the promise of more than $1.2 billion in milestones, Novartis has bought the global rights to develop an oral HDAC6 inhibitor from Chong Kun Dang Pharmaceutical.
The cell therapy-focused biotech will use most of the net proceeds from its initial public offering to fund Phase II clinical trials for its lead program, a novel CAR T-cell candidate.
In the third quarter, Vertex Pharmaceuticals reported revenue of $2.48 billion, a 6% increase from the same period in 2022. However, these figures fell short of Wall Street’s consensus estimates.