The US has become the second western country to give an emergency use authorisation to a Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc. The vaccine, BNT162b2, is based on messenger RNA (mRNA), a technology never before used in a human vaccine. It was given an emergency authorisation by the Food and Drug Administration on 11 December for individuals 16 years and over.
An agreement setting the terms of trade between the UK and the European Union following Brexit remains unresolved, according to the European Commission. The two sides have been negotiating for weeks to reach a trade agreement that would take effect from 1 January 2021. A telephone call on 5 December between the UK Prime Minister Boris Johnson and the European Commission President Ursula von der Leyen did not resolve differences on three issues. These issues are maintaining a level playing field for trade; fishing rights and governance.
The first drug for imaging prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer was approved by the US Food and Drug Administration on 1 December. It is designed to be used with positron emission tomography (PET). The drug, Gallium 68 PSMA-11, is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. It is also indicated for patients with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels.
The UK government has authorised the emergency use of a new vaccine for the prevention of Covid-19 from Pfizer Inc and BioNTech SE – the first approval of a pharmaceutical product based on messenger RNA (mRNA) technology. The decision, announced on 2 December, was based on a recommendation of the Medicines and Healthcare products Regulatory Agency (MHRA), the independent regulator. It follows the publication of Phase 3 data for the vaccine showing that it achieved an efficacy rate of 95%. The efficacy rate applies to trial participants without prior SARS-CoV-2 infection.
Moderna Inc is poised to make regulatory filings in the US and Europe today for its Covid-19 vaccines. This follows the release of new data from a Phase 3 study showing that the messenger RNA (mRNA) vaccine achieved an efficacy rate of 94.1%. The placebo-controlled study involves 30,000 participants.
A new drug combination has received an emergency use authorisation (EUA) from the US Food and Drug Administration for adults and children in hospital with Covid-19 and requiring supplemental oxygen or other life support measures. The treatment combines the anti-viral drug remdesivir with baricitinib, a marketed medicine for rheumatoid arthritis.
Bamlanivimab, a monoclonal antibody directed against the coronavirus spike protein, has been cleared by the US Food and Drug Administration for use in patients with mild-to- moderate Covid-19. The emergency use authorisation (EUA) was issued on 9 November.
A new medical device designed to reduce sleep disturbances in adults affected by post-traumatic stress disorder has been approved by the US Food and Drug Administration. The digital device is intended for use with prescribed medications for the disorder and other recommended therapies for stress-related nightmares.
From the personal computer to the iPhone, digital technologies have long been a feature of global communications. More recently, they have also begun to alter the landscape in healthcare. This was one of the themes addressed by Zaïde Frias of the European Medicines Agency to attendees of the Medtech & Pharma Platform virtual conference on 22 October. Ms Frias is head of the digital business transformation task force at the EMA, one of four groups set up by the agency in early March to prepare for new medical technologies.
The anti-viral treatment Veklury (remdesivir) has been authorised in the US for the treatment of patients with Covid-19 who require hospitalisation – the first coronavirus treatment to receive a full Food and Drug Administration approval. Announced on 22 October, the decision covers the drug’s use for patients 12 years and older. It follows the agency’s more restrictive emergency use authorisation (EUA) for Veklury, issued in May, which will now only cover the drug’s use in young children.