First evidence of clinical trial efficacy for COVID-19 vaccine

Pfizer and BioNTech have announced preliminary phase 3 trial results of their mRNA-based SARS-CoV-2 vaccine, BNT162b2. According to the first interim efficacy analysis, the trial demonstrated evidence of efficacy against COVID-19 in participants with no prior evidence of SARS-CoV-2 infection.
The vaccine consists of a two-dose …

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NICE recommends liraglutide for managing obesity

In a final appraisal determination, NICE has recommended liraglutide (Saxenda) for managing obesity in adults, alongside a reduced calorie diet and increased physical activity.
It is recommended only in patients with a BMI ≥35 (with appropriate adjustment for minority ethnic groups) and with non-diabetic hyperglycaemia (ie …

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New EMA marketing authorisation recommendations

At its latest meeting in October, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on nine new medicines (excluding generics), including several novel gene therapies. These recommendations have now been forwarded to the European Commission for a final decision …

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NICE and SIGN developing Long COVID guideline

NICE and the Scottish Intercollegiate Guidelines Network (SIGN) have announced that they are working with the RCGP to co-develop a new rapid COVID-19 guideline addressing Long COVID.
Long COVID is a condition that describes persistent symptoms of COVID-19 following on from the acute infection, regardless of …

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New guidance on naldemedine for opioid-induced constipation

NICE has published new technology appraisal guidance (TA651) on the use of naldemedine (Rizmoic) for the treatment of opioid-induced constipation.
NICE recommends naldemedine as an option for treating opioid-induced constipation in adults who have had laxative treatment (ie according to the terms of its marketing authorisation). …

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EMA conducts rolling review of two COVID-19 vaccines

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has started rolling review of two COVID-19 vaccines currently in clinical trials.
A rolling review is used to speed up the assessment of a promising new medicine or vaccine during a public health emergency. In this …

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New marketing authorisation recommendations from the CHMP

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended four new medicines (not including generics or biosimilars) for approval at its September meeting.
It has granted a positive opinion for Exparel, a new formulation of bupivacaine (liposome injectable suspension) for the treatment of …

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Corticosteroids reduce mortality in critically ill patients with COVID-19

A meta-analysis by the WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working group has provided more evidence that systemic corticosteroids can reduce mortality in critically ill patients with COVID-19 (JAMA 2 September 2020; DOI: doi:10.1001/jama.2020.17023).
The prospective meta-analysis of seven randomised trials from 12 countries …

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New guidance on rehabilitation for complex psychosis

NICE has published guidance on mental health rehabilitation for adults with complex psychosis (NG181). The aim is to promote a positive approach to long-term recovery and to ensure that people have access to help when they need it.
NICE defines complex psychosis as a primary diagnosis …

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NICE publishes new guideline on perioperative care

NICE has published a new guideline on perioperative care in adults undergoing elective or emergency surgery, including dental surgery (NG180). The guidance covers all stages of perioperative care from booking in to post-discharge, including recommendations on preparation for surgery, safety during surgery and pain relief …

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