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Opinion: Mifepristone court ruling makes drug development riskier for everyone
The biotech industry has long operated on a simple premise: FDA-regulated, evidence-based science determines how medicines reach patients, not litigation. That premise was already tested in an earlier Texas case challenging mifepristone’s FDA approval — an unprecedented effort to unwind decades of scientific review through the courts. It is now, once again, under strain.
On Friday, the 5th Circuit Court of Appeals reinstated an in-person dispensing requirement for mifepristone, a medication that has been used safely by millions for more than two decades. The drug manufacturer, Danco, appealed to the Supreme Court within hours and on Monday morning, SCOTUS granted one-week stay halting the order. In other words, mifepristone is available again through the mail and at pharmacies — but it’s unclear for how long that will be true. And it signals that even well-established, FDA-approved medicines are vulnerable to judicial override of FDA regulatory decisions.
The biotech industry has long operated on a simple premise: FDA-regulated, evidence-based science determines how medicines reach patients, not litigation. That premise was already tested in an earlier Texas case challenging mifepristone’s FDA approval — an unprecedented effort to unwind decades of scientific review through the courts. It is now, once again, under strain.
On Friday, the 5th Circuit Court of Appeals reinstated an in-person dispensing requirement for mifepristone, a medication that has been used safely by millions for more than two decades. The drug manufacturer, Danco, appealed to the Supreme Court within hours and on Monday morning, SCOTUS granted one-week stay halting the order. In other words, mifepristone is available again through the mail and at pharmacies — but it’s unclear for how long that will be true. And it signals that even well-established, FDA-approved medicines are vulnerable to judicial override of FDA regulatory decisions.
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New webinar: Tackling drug discovery challenges in cancer research

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.
You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.
Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.
Q&A with the speakers follows the presentations.
The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).
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Psilocybin proves promising in neuropathic pain mouse study
Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.
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New Spectrometry Technique Could Aid Formulation Development
New Spectrometry Technique Could Aid Formulation Development
A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.
According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.
“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”
Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.
The challenge is understanding the link between these things within a heterogeneous sample, he says.
To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.
He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.
Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.
Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.
The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.
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