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STAT+: Pharmalittle: We’re reading about Pfizer’s emergency penicillin program, a Sanofi diabetes drug, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …

The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases. 

German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned ​they may be unable to launch innovative medicines ‌in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany ⁠will cap rapidly growing costs in the statutory health ​insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra ​revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry ​thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.

Continue to STAT+ to read the full story…

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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …

The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases. 

German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned ​they may be unable to launch innovative medicines ‌in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany ⁠will cap rapidly growing costs in the statutory health ​insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra ​revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry ​thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.

Continue to STAT+ to read the full story…

​Read More

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New webinar: Tackling drug discovery challenges in cancer research

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Cancer cells

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.

Register for free now.

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

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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

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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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