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Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

Pink Sheet reporters and editors discuss Pfizer’s abrupt decision to withdraw Oxbryta, the US FDA’s Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending, and the new CEO of a generic industry trade association.

The US FDA Oncology Center of Excellence head also urged companies to commit to offer their PD-L1 drugs to certain patients free of charge via compassionate use if the gastric and esophageal cancer labeling is modified.

With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.

New guidance from the European Commission on clinical trial validity for forthcoming joint clinical assessments has eased some concerns about the generation of evidence for rare disease treatments and advanced therapies.

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors. 

The clinical road has been pretty rocky for dapirolizumab pegol but a Phase III win is good news for the limited armamentarium of innovative treatments for lupus and a boost for Biogen’s hopes to expand its presence in immunology.

In this podcast, Andrew Warmington, Manufacturing Editor, Citeline, joins together with industry experts, Simone Secchi, R&D Process Chemist, Olon Group, and Matthieu CULIE, Head of MAB, Pierre Fabre, to discuss the challenges in the development and manufacturing of ADCs.

The US' approach to international trade and potential for new tariffs on China or other partners could be the most significant issue for the beauty industry ahead of the presidential election in November, experts suggested at the Independent Beauty Association’s Cosmetics Convergence Fall 2024 Symposium.