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.

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المصدر: STAT News