Manufacturing

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Thibaut Mongon is out as Kenvue CEO, a post he’s held since J&J spun it out in July 2023, after the firm’s results came under increased investor scrutiny over the past year. The board appointed as interim CEO Kirk Perry, a board member since December who most recently headed technology, data and pre

First Insight survey with 1,267 US consumers showed 44% are more likely to try a private label product “marketed as a dupe of a high-end product.” Providers of OTC drugs as well as other medical products in US would tread on thin regulatory ice with the practice.

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

Chinese API exports to US fell 24% year-on-year to $255m in May, when US and China called a truce in a previously escalating trade war.

Bio Usawa’s CEO said access to advanced biologics should not be a privilege of geography or income, as it prepares to launch Formycon/Bioeq’s ranibizumab biosimilar in Africa.

Sandoz has begun constructing a major biosimilars manufacturing facility in Slovenia that is set to become operational in 2028. A $440m investment in the project adds to local biosimilars initiatives that together total over $1bn, helping Sandoz to move out of the shadow of former parent Novartis.