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Ensovibep shows promise as an antiviral for COVID-19
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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Clinical Trials
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European Commission approves Lumykras® for lung cancer treatment
Amgen’s Lumykras® (sotorasib) has been approved for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
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mRNA vaccine for Epstein-Barr Virus enters Phase I trial
The first patient dosed in Phase I study of Moderna’s mRNA-1189, a vaccine candidate for Epstein-Barr Virus (EBV).
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Dystrogen begins trial for Duchenne muscular dystrophy cell therapy
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
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
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
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Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
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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ABPI publishes new roadmap to aid in ATMP development
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
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Digital transformation will improve clinical trial process, say experts
In a new survey, 35 percent of healthcare professionals believe that digital transformation would improve pre-clinical and clinical trials.
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Novavax’s COVID-19 vaccine highly effective in preventing disease
New Phase III trial data suggests Novavax’s investigational COVID-19 vaccine, NVX-CoV2373, is 90 percent effective at preventing COVID-19 illness.
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UK regulator publishes guidance on use of real-world data to support clinical trials
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
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Cilta-cel achieves progression-free survival in multiple myeloma patients
In the Phase Ib/II trial, cilta-cel achieved minimal residual disease negativity in 92 percent of patients and improved survival.
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mRNA-1010 quadrivalent flu vaccine shows promise in Phase I study
Moderna's quadrivalent flu vaccine mRNA-1010 boosted titres against all four strains 29 days after vaccination in young and older adults.
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Gene therapy sustains bleeding control in haemophilia A trial
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
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Beovu® shows positive results in two-year Phase III trial
Beovu® maintained best-corrected visual acuity (BCVA) and reduced central subfield thickness (CSFT) in diabetic macular edema patients.
