Skip to main content

Helixgate

Skip to main content

Helixgate

Uncategorized

STAT+: Pharmalittle: We’re reading about a Lilly threat to 340B hospitals, Ebola vaccine funding, and more

Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is old-fashioned green tea. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips….

Eli Lilly has told about 50 hospitals participating in a federal drug discount program to submit comprehensive claims data over the next five days or they will no longer receive the mandated price breaks, STAT writes. The move comes after the company announced a policy last January demanding such data in a bid to reduce what it calls duplicate discounts paid to participating hospitals. For the past few years, more than 2,300 hospitals have complied with the demand, but Lilly said that some of the larger hospitals systems around the U.S. have refused to do so, despite recent follow-up letters regarding the policy that went into effect on Feb. 1.  Up to 1,000 have so far not complied.

The U.S. Food and Drug Administration is scheduled to have a closed-door roundtable this week with over a dozen groups advocating for rare disease treatments, Bloomberg Law reports. The meeting, scheduled for Wednesday, will connect FDA Acting Commissioner Kyle Diamantas and other senior agency officials with at least 10 rare disease groups for a private conversation about advancing treatments that often struggle to meet the agency’s rigorous approval process. The meeting comes as the rare disease community has sought more clarity from regulators amid turmoil over recent decisions for rare drugs. Under former Commissioner Marty Makary, who resigned last month, several initial rejections were issued to companies seeking to market rare disease drugs and gene therapies.

Continue to STAT+ to read the full story…

​Read More

Published

on

Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is old-fashioned green tea. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips….

Eli Lilly has told about 50 hospitals participating in a federal drug discount program to submit comprehensive claims data over the next five days or they will no longer receive the mandated price breaks, STAT writes. The move comes after the company announced a policy last January demanding such data in a bid to reduce what it calls duplicate discounts paid to participating hospitals. For the past few years, more than 2,300 hospitals have complied with the demand, but Lilly said that some of the larger hospitals systems around the U.S. have refused to do so, despite recent follow-up letters regarding the policy that went into effect on Feb. 1.  Up to 1,000 have so far not complied.

The U.S. Food and Drug Administration is scheduled to have a closed-door roundtable this week with over a dozen groups advocating for rare disease treatments, Bloomberg Law reports. The meeting, scheduled for Wednesday, will connect FDA Acting Commissioner Kyle Diamantas and other senior agency officials with at least 10 rare disease groups for a private conversation about advancing treatments that often struggle to meet the agency’s rigorous approval process. The meeting comes as the rare disease community has sought more clarity from regulators amid turmoil over recent decisions for rare drugs. Under former Commissioner Marty Makary, who resigned last month, several initial rejections were issued to companies seeking to market rare disease drugs and gene therapies.

Continue to STAT+ to read the full story…

​Read More

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Uncategorized

New webinar: Tackling drug discovery challenges in cancer research

Published

on

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).

Continue Reading

Uncategorized

Psilocybin proves promising in neuropathic pain mouse study

Published

on

Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.

Continue Reading

Uncategorized

New Spectrometry Technique Could Aid Formulation Development

New Spectrometry Technique Could Aid Formulation Development

Published

on

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.

Continue Reading

Trending

Helixgate Biotech Review July Issue QR CodeScan to Read