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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

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NK cell immunotherapy: what’s next in clinical development?

European Pharmaceutical Review

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. As a biotech, what work does Innate Pharma do in the biopharma industry? Can you describe Innate Pharma’s clinical stage pipeline?

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. You can compare timelines.

Pharma 64
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. Moreover, off-target effects from conventional BTKis result in a suboptimal safety profile, which the enhanced selectivity of PROTACs can help mitigate.

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Japan’s M&A Boom

Pharmaceutical Technology

But the recent acquisition by Japanese pharmaceutical provider Shionogi of US-based rival Sciele Pharma, worth $1,276m, is just the latest in a spree of big and bold outbound deals. “In 2001, Japan’s Taisho Pharmaceutical tried to merge with Tanabe, but it failed due to differences in corporate culture.’

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. The micronized capsule was progressed to Part 2 of the study and showed a linear increase in exposure (AUC) up to 800 mg, establishing safety margins for future clinical testing. S54 – S61 (2001). Grass and P.