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US legislative update: takeaways for European pharma

European Pharmaceutical Review

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts.

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Biosimilars Market Set for Biggest Year Yet in 2023

PM360

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. pharmaceutical industry.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

To keep the EU’s medicine supply intact, Gupta suggests governments should adopt new pricing policies and provide further aid to mitigate the impact of rising operational costs; they should also minimise the exodus of generics manufacturers. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.