ADVERTISEMENT

Hormonal

Rilzabrutinib & First Biosimilar Golimumab Among New EU Filings

Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products for which marketing applications are currently under review. Both drugs are investigational and are yet to be approved anywhere in the world.

FDA Publishes Updated Roadmap For Advancing Women’s Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior

France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile. 

ESMO 24: Pfizer To Take Cancer Weight Gain Drug Into Phase III

Pfizer will talk to regulators about pivotal study designs in cachexia following promising ponsegromab Phase II data, with results from a separate study in heart failure also coming soon.

BridgeBio Bows Out With CAH Gene Therapy Despite Trial Success

The company said the results did not meet the threshold for continued capital investment, giving a boost to Spruce Biosciences and its competing congenital adrenal hyperplasia program.

Biolinq Aims To Transform Diabetic Glucose Monitoring With Needle-Free Patch

Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Women’s Health Innovation: What Are We Waiting For?

An investigator, an investor and an inventor walk into the New York Stock Exchange, and it’s no joke. Women’s health is a fruitful investment with a clear path to financial return. 

Corcept’s Coup De GRACE

The follow-on Cushing’s product relacorilant has hit in Phase III, and is forecast to lead the market – eventually.