EC grants conditional marketing authorisation for remdesivir

The European Commission has granted a conditional marketing authorisation for remdesivir (Veklury), for the treatment of COVID-19 in adults and adolescents from 12 years of age (and body weight at least 40kg) with pneumonia who require supplemental oxygen.
The European Commission’s decision was made just over …

More details...

Dexamethasone reduces mortality in patients with severe respiratory complications of COVID-19

Dexamathasone reduces death by up to one-third in hospitalised patients with severe respiratory complications of COVID-19, according to the latest results released from the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial.
The RECOVERY trial was established as a randomised clinical trial to test a range of …

More details...

EMA reinforces advice on continuation of ACE inhibitors and sartans during the pandemic

The EMA has restated its previous advice that patients should continue to use ACE inhibitors or angiotensin II-receptor blockers (ARBs, also known as sartans) as advised by their doctor during the COVID-19 pandemic, following an analysis of recent observational studies indicating that these medicines do …

More details...

CHMP recommends new medicines for approval

In its most recent meeting at the end of May, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines for approval, with indications ranging from Ebola and hepatitis D to cancer and pneumonia.
 
Ebola vaccine regimen
A marketing authorisation was recommended for …

More details...

NICE publishes final guidance on fremanezumab

NICE has now published final guidance on the use of fremanezumab (Ajovy) for the prevention of migraine in adults (TA631).
The new guidance states that fremanezumab is an option for preventing migraine in adults only if the migraine is chronic (ie 15 or more headache days …

More details...

Yellow Card reporting site for COVID-19-related incidents

The MHRA has launched a new dedicated coronavirus Yellow Card reporting site to identify new and emerging side-effects and medical device incidents relating to the treatment of patients with COVID-19.
Healthcare professionals, patients and caregivers have been asked to report all suspected side-effects or incidents associated …

More details...

MHRA issues positive scientific opinion on remdesivir under the Early Access to Medicines Scheme

The MHRA has issued a positive scientific opinion for the use of the antiviral drug remdesivir in the treatment of COVID-19 in the UK under the Early Access to Medicines Scheme (EAMS).

The opinion supports the use of remdesivir for the treatment of adults and adolescents …

More details...

CHMP recommends new asthma triple combination inhaler

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for the Enerzair Breezhaler, a new asthma triple combination inhaler with an optional digital sensor.
Enerzair consists of a fixed-dose combination of indacaterol (a long-acting beta2-agonist), glycopyrronium (a …

More details...

NICE recommends new histology-independent cancer therapy

In a final appraisal determination, NICE has recommended larotrectinib (Vitrakvi) for use in NHS patients within the Cancer Drugs Fund.
Larotrectinib is a histology-independent (tumour-agnostic) therapy that targets neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumours. Up until now, most cancer therapy is based around …

More details...

UK’s first COVID-19 vaccine clinical trial underway

The MHRA-approved COVID-19 Oxford Vaccine Trial is now underway in the UK, with around 1100 healthy volunteers taking part.
Scientists at the University of Oxford’s Jenner Institute began work on the vaccine in early January 2020, in a project funded by the UK Research and Innovation …

More details...

Web design and marketing agency Leamington Spa