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STAT+: Pharmalittle: We’re reading about an AstraZeneca breast cancer pill, an ADAP deal in Florida, and more
Good morning, everyone, and how are you today? The middle of the week has finally arrived, and you should congratulate yourselves for making it this far and deciding to soldier on. After all, consider the alternatives. None too pleasant, yes? This calls for a delicious cuppa stimulation. Our choice today is pomegranate green tea. As always, we invite you to join us. Meanwhile, here are some tidbits. Hope you have a meaningful and productive day, and please do keep in touch. We treasure your messages. …
The U.S. Food and Drug Administration has extended the decision deadline for an experimental breast cancer pill from AstraZeneca in order to review additional data, Reuters notes. The delay comes after a majority of an FDA advisory panel in April voted against the drug in combination with another type of therapy known as CDK4/6 inhibitor, due to concerns about the design of a key late-stage trial rather than its safety or efficacy. The company said it has submitted additional analyses requested by the FDA to support its new drug application, including data linked to longer-term efficacy outcomes that will be presented at a conference on June 2. AstraZeneca’s camizestrant pill is designed for patients with a type of breast cancer in which tumors carry a specific mutation.
Brazil approved the country’s first generic version of Novo Nordisk’s Ozempic shot, opening the door to cheaper competition in one of the world’s fastest-growing markets for weight loss and diabetes drugs, Bloomberg News writes. EMS, a Brazilian pharmaceutical company, was cleared to sell its copycat drug, Ozivy, to treat adults with type 2 diabetes as an adjunct to diet and exercise. EMS plans to sell Ozivy for 30% less than Ozempic, and expects it to hit the market within 30 days. The approval marks a milestone for Brazil’s pharmaceutical industry as local drugmakers seek to enter the booming market for GLP-1 medicines, the class of drugs that includes Ozempic. The company plans to make 350,000 pens available initially and expects to sell about 1.2 million units in the first year.
Good morning, everyone, and how are you today? The middle of the week has finally arrived, and you should congratulate yourselves for making it this far and deciding to soldier on. After all, consider the alternatives. None too pleasant, yes? This calls for a delicious cuppa stimulation. Our choice today is pomegranate green tea. As always, we invite you to join us. Meanwhile, here are some tidbits. Hope you have a meaningful and productive day, and please do keep in touch. We treasure your messages. …
The U.S. Food and Drug Administration has extended the decision deadline for an experimental breast cancer pill from AstraZeneca in order to review additional data, Reuters notes. The delay comes after a majority of an FDA advisory panel in April voted against the drug in combination with another type of therapy known as CDK4/6 inhibitor, due to concerns about the design of a key late-stage trial rather than its safety or efficacy. The company said it has submitted additional analyses requested by the FDA to support its new drug application, including data linked to longer-term efficacy outcomes that will be presented at a conference on June 2. AstraZeneca’s camizestrant pill is designed for patients with a type of breast cancer in which tumors carry a specific mutation.
Brazil approved the country’s first generic version of Novo Nordisk’s Ozempic shot, opening the door to cheaper competition in one of the world’s fastest-growing markets for weight loss and diabetes drugs, Bloomberg News writes. EMS, a Brazilian pharmaceutical company, was cleared to sell its copycat drug, Ozivy, to treat adults with type 2 diabetes as an adjunct to diet and exercise. EMS plans to sell Ozivy for 30% less than Ozempic, and expects it to hit the market within 30 days. The approval marks a milestone for Brazil’s pharmaceutical industry as local drugmakers seek to enter the booming market for GLP-1 medicines, the class of drugs that includes Ozempic. The company plans to make 350,000 pens available initially and expects to sell about 1.2 million units in the first year.
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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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