article thumbnail

New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU.

article thumbnail

ICH Q6B for Analytics

PharmTech

Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substances: Quality Issues (revision 1) (May 22, 2014). With their technical and methodological improvements, advanced techniques provide valuable information on overall product mass profiles. Analytical Validation (ICH, 2023). Easton, R.L.

Insiders

Sign Up for our Newsletter

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

article thumbnail

A pharmacist’s take on actions from the child asthma and anaphylaxis deaths report

Hospital Pharmacy Europe

2 The National Review of Asthma Deaths (NRAD) Why asthma still kills report from 2014 was a landmark publication. Of those, the most common factor was unclear, misleading, or inaccurate food labelling (either packaged or cooked, bought from supermarkets or takeaways). 2020 [Accessed March 2025]. Royal College of Physicians.

article thumbnail

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. FDA, USP Salt Policy (December 2014). 1, 2014 (accessed April 29, 2025). Selecting of the appropriate pharmaceutical alternative requires technical judgment. YouTube.com , Dec.

article thumbnail

EC authorises Sydnexis’ paediatric myopia treatment

Pharmaceutical Technology

Founded in 2014, Sydnexis is a US-based company and has recently concluded the three-year primary endpoint of its Phase III trial of the low-dose atropine formulation. Give your business an edge with our leading industry insights.

article thumbnail

EpiPen patent expiry opens new era for innovation

Pharmaceutical Technology

The lawsuit contested that prices for a two-pack of EpiPens rose from around $100 in 2008 to $600 during the class period between March 2014 and February 2025. In January 2025, Mylan reached a $73.5m GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard.

article thumbnail

9 Sneaky Thyroid Toxins Hiding in Your Home

The Thyroid Pharmacist

In 2014, I suffered a sudden flare-up of my Hashimotos after starting to use a new lipstick. 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items. Published 2014 Jan 3. Springerplus.