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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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Regulation & Legislation
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
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MHRA approves Pfizer and BioNTech COVID-19 vaccine
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
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EC approves Dupixent for children aged six to 11 to treat severe atopic dermatitis
The EC has approved an extension of marketing authorisation for Regeneron and Sanofi's Dupixent (dupilumab) for children aged six to 11 with severe atopic dermatitis.
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Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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EMA highlights link between hydroxychloroquine and psychiatric disorders
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
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EU secures 80 million doses of Moderna COVID-19 vaccine
The European Commission and Moderna have agreed that the company will supply at least 80 million doses of mRNA-1273, the company's COVID-19 vaccine candidate.
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EC fines Teva and Cephalon €60.5 million over pay-for-delay deal
The European Commission has fined Teva and Cephalon €60.5 million for a pay-for-delay deal over Cephalon's modafinil and Teva's generic.
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EDQM releases updated pharmacopoeial quality standards for vaccines
To aid COVID-19 vaccine developers, the EDQM has released an updated European Pharmacopoeia that can be accessed for free.
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British pharma responds to UK’s Chancellor’s new Spending Review
The ABPI has commented on the new Spending Review and outlined ways the UK government can help the life sciences sector.
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EC approves Opdivo for treatment of oesophageal squamous cell carcinoma
The European Commission has approved Opdivo (nivolumab) to treat oesophageal squamous cell carcinoma after studies showed its clinical benefits compared to chemotherapy alone.
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EC approves new meningitis vaccine
MenQuadfi® has been approved for use in individuals 12 months of age and older, based on its safety and immunogenicity in 6,300 trial subjects.
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Purdue Pharma pleads guilty to criminal charges over opioids
Reports have said that Purdue Pharma has pleaded guilty to three criminal charges over issues regarding its opioid painkiller, OxyContin.
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US pharma initiates litigation challenging HHS and FDA action
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
