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International regulators call for multivalent COVID-19 vaccines
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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Clinical Trials
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Imfinzi™ reduces risk of death in biliary tract cancer patients
Patients treated with Imfinzi and chemotherapy experienced a 20 percent reduction in the risk of death versus chemotherapy alone.
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Study finds Keytruda® improves overall survival in HCC patients
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.
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CME to support just-in-time clinical trial supply
CME will support the delivery of automated just-in-time clinical supply, as one of the collaborators in the Medicines Manufacturing Innovation Centre Grand Challenge 2.
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Riluzole not beneficial for spinocerebellar ataxia type 2
Study reveals riluzole is of no benefit in spinocerebellar ataxia type 2, emphasising the importance of studying homogeneous groups of patients.
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Imfinzi™ plus tremelimumab: “unprecedented survival” in unresectable liver cancer
Almost a third of unresectable hepatocellular carcinoma patients were alive at three years on tremelimumab and Imfinzi regimen.
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New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
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mRNA COVID-19 vaccines safe for pregnant women, finds EMA 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
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
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Have your say on future UK clinical trial legislation
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.
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Promising results for COVID-19 and pneumococcal vaccine co-administration
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
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Accelerating Clinical Trials in the EU (ACT EU) initiative launch
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
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
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Keytruda® promising in adjuvant treatment of lung cancer
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
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.
