Alnylam joins the Medicines Manufacturing Innovation Centre
Alnylam joins the third Grand Challenge (GC3) consortium to help overcome barriers to the manufacture of oligonucleotides.
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Mass spectrometry for gene therapy vector analysis
Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.
EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
Lumakras™ displays positive results in Phase Ib cancer study
Lumakras™ (sotorasib) demonstrated effective response rates against non-small cell lung cancer and colorectal cancer in Phase Ib trial.
Moderna’s mRNA facility in Africa to manufacture 500 million vaccine doses
Moderna will build an mRNA facility in Africa to manufacture 500 million doses of their COVID-19 vaccine and other products per year.
Opaganib reduces COVID-19 mortality by 62 percent in Phase II/III study
Opaganib is the first oral pill-based therapy to significantly reduce mortality outcomes in hospitalised COVID-19 patients.
WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
COVID-19 vaccines will require outsourced manufacturing, says report
The pharma industry will need to outsource manufacturing for COVID-19 vaccine doses for booster doses and children, reports GlobalData.
EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
Manganese a promising new catalyst for drug synthesis
Researchers have found that manganese can simplify the process of synthesising fluoroketones for drug design and manufacture.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
NICE recommends first sickle cell disease treatment in 20 years
Crizanlizumab recommended as a treatment option for preventing recurrent sickle cell crises for people aged 16 and over in the UK.
Indian active pharmaceutical ingredients market to grow by 12.24 percent
The Indian active pharmaceutical ingredients (APIs) market stood at $11.8 billion in 2021 and continues to grow, says market report.
New EFPIA network created to combat cardiovascular diseases
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has initiated the CVD Network to improve policies for patients.
