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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!

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US trade tariffs and the potential impact on pharma supply chains

Pharmaceutical Technology

These ongoing legal challenges highlight the volatility of today’s macroeconomic environment – just one aspect of the complex and volatile world that pharmaceutical manufacturers now find themselves in. Introduced just a few months ago, Trump’s policies are already reshaping the pharmaceutical manufacturing landscape.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

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Global impact: How regulatory affairs is shaping development of cutting-edge pharma innovation

pharmaphorum

As these innovations – which have the potential to be transformative for patients – enter uncharted regulatory territory, the pathway is not always clear or well-defined, which is why Astellas adopts a proactive approach to early communication with health authorities. “We Looking to the future.

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Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods

Quality Matters

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients. Senior Director, General Chapters Global Science and Standards Division.

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How to use quality risk management in validation testing

GMPSOP

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? All written and updated by GMP experts. Checkout sample preview s.