Remove 2001 Remove Leads Remove Pharma Remove Safety
article thumbnail

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).

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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. This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.

article thumbnail

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.

article thumbnail

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.’