CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
X-ray imaging enables automated parenteral product particulate inspection
X-ray imaging was able to detect all common particulates in lyophilised drug product and provide information of the cake structure in a new study.
Imfinzi™ improves overall survival in biliary tract cancer (BTC) patients
Imfinzi plus chemotherapy is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care for BTC.
Second Phase III study supports Dupixent® for eosinophilic oesophagitis
Dupixent® reduced eosinophilic oesophagitis symptoms by 64 percent compared to placebo and met primary endpoints in second Phase III study.
Comirnaty® booster dose displays high efficacy in Phase III study
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
Pepsin key for fast and efficient AAV peptide analysis, finds study
Researchers have created a new workflow using pepsin to expedite the LC-MS analysis of adeno associated virus (AAV) capsid proteins for gene therapies.
Dupixent® reduces itch by 37 percent in prurigo nodularis patients
Dupixent® is the first biologic to significantly reduce itch and skin lesions in Phase III trial for prurigo nodularis.
Stabiliser-free PLGA nanoparticle formulation shows promise for drug delivery
Scientists have developed a stabiliser-free, non-toxic poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation for use in drug and vaccine delivery.
Tirzepatide maintains AC1 and weight control in type 2 diabetes patients
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7kg in Phase III study.
Heterologous COVID-19 booster doses show 68 percent effectiveness
A Swedish study found that heterologous Vaxzevria and mRNA prime-boost vaccination is effective against COVID-19.
New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
Interferon treatment reduces leukaemia recurrence by 20 percent
Interferon treatment with a bone marrow transplant bolstered outcomes for patients with advanced, high-risk leukaemia.
Excipient knowledgebase to optimise the formulation and dosing of drugs
Researchers have compiled a repository of clinical and in vitro data for excipients to enable their potential to interact with drugs to be modelled.
