Switzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
Manufacturers of (bio)pharmaceuticals, medical devices and in vitro diagnostics have the opportunity to lead the way in the defossilisation of organic chemicals. Here Martin Held from the Institute of Biotechnology of the Swiss Federal Institute of Technology and Roche’s Stefan Koenig, Martin Olbrich and Jan Backmann propose how to reduce…
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
Insulin for at least one million diabetics in low- and middle-income countries, mainly in Africa, is the aim of Eli Lilly and EVA Pharmaceutical's new collaboration.
Sited in Belgium, Catalent has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world.
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
A 2022 WHO report is the first to portray COVID-19’s impact on the global vaccine market, identifying that lower-income countries struggle to access critical vaccines.
The 2022 Access to Medicine Index shows all 20 pharma companies have an over-arching access to medicine strategy, benefitting low and middle-income countries.
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
If successful in further clinical trials an innovative, cost-effective COVID-19 vaccine patch could be available as early as 2025.
Sandoz will invest €50 million in new Austrian finished dosage form manufacturing site, to support the global demand for penicillin products.
In a global first, the health sector has converged to incentivise supply chains and clinical trials to reduce emissions through the Sustainable Markets Initiative Health Systems Task Force.
COVID-19 vaccine key players back a new proposal ensuring vaccines for future pandemics are equally distributed to all priority populations.
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.