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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. However, it is clear that changes are likely to have meaningful impacts for biopharma players if adopted.

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Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 is to acquire the 2015-established Amryt Pharma Plc. on 6 th January.

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The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. Now, as the President of Accord BioPharma , the U.S. he is responsible for leading the commercialization efforts of specialty products which includes a broad portfolio of biosimilars.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

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U.S. market access landscape: A push for control is erasing the boundary between payers and providers in U.S. healthcare

Clarivate

The drug store entered the retail clinic business in summer 2006 by acquiring Minneapolis-based MinuteClinic, an already-established chain of retail-based healthcare clinics with many locations inside CVS pharmacies. CVS’ bid for Oak Street is in keeping with nearly two decades of evolution toward becoming an integrated payer and provider.

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

The evidence standards that a COA must meet to support key clinical trial endpoints have become increasingly stringent in recent decades, following the introduction of the United States Food and Drug Administration (FDA) Patient Reported Outcomes (PRO) draft guidance in 2006, followed by the full guidance in 2009.