MHRA

EU ‘negotiating with Valneva’ over COVID-19 vaccine contract

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a …

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Valneva slumps as UK dumps €1.4bn order for COVID-19 jab

The UK has terminated its order for up to 190 million doses of a COVID-19 vaccine developed by French biotech company Valneva, accusing it of breaching their supply agreement. Valneva said it “strenuously denies” that allegation, but added that the €1.4 billion ($1.65 billion) contract does provide the UK government with the right to exit …

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NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and …

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MHRA clears third doses of AZ, Pfizer COVID jabs

The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) …

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Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo

Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The green light covers England, Scotland Wales, as Northern Ireland remains under the EU regulatory framework, and covers once-daily use of the orally-active drug in adolescents aged over 12 …

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MHRA cuts could affect UK regulatory decisions, say unions

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. In an open letter to Health Secretary Sajid Javid, Prospect, Unite and three other unions say the decision to slash the MHRA’s current …

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MHRA clears Moderna COVID vaccine for 12 to 17 year olds

The Moderna COVID-19 vaccine has become the second jab to be authorised for use in England, Scotland and Wales in children aged 12 to 17 after getting the nod from the Medicines and healthcare products Regulatory Agency (MHRA). It joins the Pfizer/BioNTech vaccine in being an option for that age group, having been approved in …

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GW’s Epidyolex (cannabidiol) Receives MHRA’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK

Shots: The approval is based on P-III safety & efficacy study that evaluates Epidyolex (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment with seizures associated with TSC The study met its 1EPs i.e., reduction in seizure frequency (49% vs 27%). The 2EPs had supported the effects on 1EPs & safety profile …

GW’s Epidyolex (cannabidiol) Receives MHRA’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK Read More »

Merck’s targeted lung cancer drug tepotinib wins early access in UK

The UK drugs regulator has backed Merck KGaA’s MET inhibitor for the treatment of some patients with non-small cell lung cancer under the early access to medicines scheme (EAMS). The EAMS – first introduced in 2014 – provides a route for drugmakers to provide earlier availability of promising new unlicensed medicines to patients with few …

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Janssen COVID jab cleared in UK as fears of third wave mount

With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson’s Janssen division. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision …

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UK will offer under-30s alternative to AZ’s COVID jab

The UK drugs regulator has said people aged under 30 should be offered an alternative to the AstraZeneca COVID-19 vaccine, because of evidence linking it to rare blood clots.  Updated figures from the Medicines and Healthcare products Regulatory Agency (MHRA) reveal 79 people experienced blood clots after receiving a dose of Vaxzevria (AZD1222), with 19 …

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Paediatric trial of AZ COVID jab ‘halted as a precaution’

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator.  Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they …

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MHRA launches patient involvement pilot for drug applications

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process.  The voluntary scheme by the Medicines and Healthcare products Regulatory Agency (MHRA) aims to inject a dose of “patient centricity” into medicines development – something that has been …

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New era of genomic medicine begins as UK approves Lilly’s Retsevmo

The UK regulator has authorised Eli Lilly’s targeted cancer drug Retsevmo for tumours with RET fusion positive lung cancers and thyroid cancers, which the company said could herald a new era of genomic medicine for the NHS. The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Retsevmo (selpercatinib) as monotherapy for …

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MHRA approves Seagen’s oral HER2 drug Tukysa

The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after it was given a green light by the European Commission.  Tukysa (tucatinib) – an orally-active HER2 inhibitor – can be used in combination with anti-HER2 antibody trastuzumab and chemotherapy capecitabine in patients treated with two prior anti-HER2 …

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2021 – UK market access prospects

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Looking back at key market access news …

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Moderna’s COVID-19 vaccine is third approved in UK

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after …

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AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday. The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million …

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AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Shots: The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses administered with an interval of between 4 & 12wks The authorization is based on independent advice from its CHM following a rolling review of trial data that included an interim …

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FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against …

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Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI The MHRA’s decision is based on a rolling submission, including data from the P-III study, …

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Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying. The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands …

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MHRA looks to AI to hunt for COVID-19 vaccine side effects

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).” The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as …

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UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran

The UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria type 1 to gain access ahead of a regulatory decision by the European Commission.  The Medicines and Healthcare products Regulatory Agency (MHRA) gave a positive opinion for lumasiran through its Early Access to Medicines Scheme (EAMS).  Eligible patients in the …

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