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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New strategy could improve generic drug quality assessments
Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.
Britons expect continued collaboration in (bio)pharmaceutical research
Survey finds British adults expect pharma to continue to work together to advance both COVID-19 treatments and innovations for other diseases.
Pfizer and BioNTech to develop mRNA shingles vaccine
New collaboration between Pfizer and BioNTech will develop an mRNA vaccine to combat shingles (herpes zoster virus).
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).
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.
Plasma-based engineering to accelerate antimicrobial material development
Could plasma-based engineering provide a greener method to produce antimicrobial materials, such as contact-killing, antifouling and drug-release surfaces?
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.
US healthcare groups publish drug supply chain recommendations
Healthcare groups including the US Pharmacopeia and American Medical Association release advice for policymakers on addressing challenges in the US supply chain.
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.
New Digital Grand Challenge announced by CPI
The Centre for Process Innovation (CPI) reveals the National Physical Laboratory, StreamNative and Wyoming will collaborate on new projects to drive digital medicines manufacturing technology.
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.
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.
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.
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.
