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Clinical Trials

Idea of vaccination for pregnant women - doctor's gloved hand holding a syringe in front of a pregnant woman

mRNA COVID-19 vaccines safe for pregnant women, finds EMA review

19 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.

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Rare Disease Clinical Outcome Assessment Consortium launched

18 January 2022 | By European Pharmaceutical Review

The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.

New Bill could enhance UK clinical trial regulation

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Have your say on future UK clinical trial legislation

18 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.

Close up of doctor holding a syringe ready to vaccinate a patient in their upper arm

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Promising results for COVID-19 and pneumococcal vaccine co-administration

14 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.

concept of clinical trials - stethoscope and pill packets on a wooden board background

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Accelerating Clinical Trials in the EU (ACT EU) initiative launch

14 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.

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NICE recommends Rinvoq^® for adults with active psoriatic arthritis

14 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.

Phogomicrograph of fine needle aspiration (FNA) cytology of a pulmonary (lung) nodule showing adenocarcinoma, a type of non-small cell lung cancer

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Keytruda^® promising in adjuvant treatment of lung cancer

12 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

MSD/Merck reveals Keytruda® (pembrolizumab) significantly improved disease-free survival in adjuvant treatment of non-small cell lung cancer (NSCLC) patients.

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Graft engineering sees potential to reduce GVHD risk in leukemia patients

11 January 2022 | By European Pharmaceutical Review

New study shows risk of developing graft-versus-host disease (GVHD) in leukaemia patients reduced by removing naïve T cells from donor blood used for stem cell grafts.

Covid-19 treatment concept - red pill labelled COVID-19 surrounded by blank white capsules

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Ensovibep shows promise as an antiviral for COVID-19

10 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

Phase II trial data suggests ensovibep (MP0420) significantly reduces SARS-CoV-2 viral load and reduces hospitalisation and death due to COVID-19.

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European Commission approves Lumykras^® for lung cancer treatment

10 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

Amgen’s Lumykras® (sotorasib) has been approved for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.

syringe drawing from a vaccine from a vial

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mRNA vaccine for Epstein-Barr Virus enters Phase I trial

6 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The first patient dosed in Phase I study of Moderna’s mRNA-1189, a vaccine candidate for Epstein-Barr Virus (EBV).

Idea of regenerative medicine/cell therapy - cells and a DNA strand in blue

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Dystrogen begins trial for Duchenne muscular dystrophy cell therapy

5 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The first patient has been infused in the Phase I pilot study of DT-DEC01, a chimeric cell therapy for Duchenne muscular dystrophy.

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First drug for acute graft-versus-host disease prevention approved by FDA

22 December 2021 | By Hannah Balfour (European Pharmaceutical Review)

BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.

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EMA recommends GSK’s Xevudy for the treatment of COVID-19

21 December 2021 | By Hannah Balfour (European Pharmaceutical Review)

The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.

Futuristic antiviral medication against coronavirus sars-cov2 viral disease covid-19 with glowing red capsule pill and virus cells on dark blue background.

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Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA

20 December 2021 | By Hannah Balfour (European Pharmaceutical Review)

New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.

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Clinical Trials