A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
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Within this issue are articles which investigate polyelectrolyte multilayers as drug carriers, discuss how developments in pharma impact logistics and examine how the industry can regulate heavy metals in medicinal cannabis. Other features include how use use the correct tablet tooling and trends for the CDMO sector this year.
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
A new bill is now effective in the UK which aims to improve regulation for medical devices and ensure patient safety, as well as allow hospitals to develop personalised medicines.
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
The US Food and Drug Administration (FDA) has granted Priority Review for capmatinib, a treatment for MET exon 14 skipping mutated non-small cell lung cancer.
A report suggests that instead of taxing medical device imports, the Indian government should offer tax rebates to multinational companies if they partner with domestic device manufacturers.
The government in the UK has told pharmaceutical businesses to examine the risk that coronavirus poses to the supply chain and retain any stockpiles from Brexit to mitigate shortages.
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
EFPIA, Medicines for Europe and AESGP have called for a Mutual Recognition Agreement on good manufacturing practice in regards to the future relationship between the UK and the EU.
Research has found that technological innovation and legislation are to drive the growth of the global anti-counterfeit packaging market.
Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU.
Experts in the UK have called for government action to resolve the shortages of hormone replacement therapy and now contraceptives.
Mavidon has recalled LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to the products being potentially contaminated with Burkholderia cepacia.
The US FDA has approved AUDENZ, a vaccine formulated with MF59® adjuvant, as an Influenza A H5N1 vaccine that can be quickly deployed in the event of a pandemic.