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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.

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Labelling of Dispensed Medicine

RX Note

NOTE: The dispensing label must not obscure the active ingredient(s), strength, and expiry date as printed on the manufacturer's packaging. Complete the course" for antibiotics, "May cause drowsiness" for sedating drugs, etc.) Include the maximum dose, if relevant , such as for paracetamol.

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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. IPA also addressed concerns regarding transparency in drug manufacturing locations.

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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.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9% How will RFK Jr’s American dream for vaccines play out? The rising cost of clinical trials Clinical trials have always been expensive, but costs are reaching new heights. per year over this decade.

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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.

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EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

Pharmaceutical Technology

The US Food and Drug Administration (FDA) approved Amgen’s Blincyto (blinatumomab), the first bispecific T-cell engager (BiTE), in 2014 for adults with Ph- R/R B-ALL, with its label expanded in 2017 to include Ph+ and paediatric cases. Give your business an edge with our leading industry insights.