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Updated restrictions announced for multiple sclerosis treatment
A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
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European Pharmaceutical Review Issue 1 2020
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.
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FDA requests market withdrawal of weight-loss drug Belviq
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.
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Medicines and Medical Devices Bill introduced in UK
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.
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MHRA suspends license for Picato over concerns of skin malignancy risk
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.
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FDA grants Priority Review to capmatinib – a targeted lung cancer therapeutic
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.
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Indian medical device manufacturers need support from multinational companies, says report
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.
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UK government urges pharma to assess impact of coronavirus on supply chain
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.
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The FDA and FTC team up to prevent anti-competitive practices
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.
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Pharma industry calls for GMP agreement between EU and UK
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.
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Anti-counterfeit drugs packaging market growing at 13.2 percent CAGR
Research has found that technological innovation and legislation are to drive the growth of the global anti-counterfeit packaging market.
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Resolving and mitigating medicine shortages in the EU
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.
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Leading doctors call for action to address HRT and contraceptive shortages in UK
Experts in the UK have called for government action to resolve the shortages of hormone replacement therapy and now contraceptives.
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Skin preparation electrode gel recalled due to infection risk to patients
Mavidon has recalled LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to the products being potentially contaminated with Burkholderia cepacia.
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FDA approves AUDENZ™, an adjuvanted Influenza A pandemic vaccine
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.