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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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Anna Begley (European Pharmaceutical Review)
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EMA launches the Regulatory Science Research Needs initiative
The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.
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Supply chain risks force significant shift to near-shore medicines sourcing
With global supply chains under stress due the pandemic, European pharma companies are increasingly looking for alternative supply channels.
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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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Experimental gene therapy reverses sickle cell disease for three years
The gene therapy corrected the shape of some sickle cell patients' red blood cells and eliminated episodes of severe pain.
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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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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.
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EMA recommends RoActemra in adults with severe COVID-19
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
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FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
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Digital pill tracks HIV prevention pill adherence with 98 percent accuracy
Scientists found digital pill systems to be a 98 percent accurate intervention to help men adhere to pre-exposure prophylaxis (PrEP) regimens.
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AstraZeneca and Ionis to develop and commercialise eplontersen
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals for eplontersen.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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Astellas and Dyno Therapeutics to develop AAV gene therapy vectors
Astellas and Dyno Therapeutics will develop adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle.
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
