CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
A new clinical study by Pfizer Inc. and BioNTech SE, and Phase II study by Moderna, are seeking to evaluate the immunogenicity and safety of Omicron-based vaccines and boosters.
Katalin Karikó, Robert Langer and Drew Weissman win BBVA Foundation Frontiers of Knowledge Award in Biology and Biomedicine for driving the advance of messenger RNA (mRNA) therapeutics.
Researchers demonstrate the efficacy and safety of stabilising protein drugs with a reversible PEGylation material called PEG-PRX.
Newly published Network Meta-Analysis (NMA) from Janssen indirectly compares all published Phase III data for approved treatments for adults with active Psoriatic Arthritis (PsA).
Based on the latest data, and Omicron's current dominance in the US, the FDA has announced two monoclonal antibody treatments are not authorised for use in any US states, territories and jurisdictions at this time.
How close are we to oral biologic drug delivery? Will biomedical devices be essential in overcoming drug delivery challenges? Discover all this and more in this podcast with MIT's Assistant Professor Giovanni Traverso.
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
US researchers have been granted $930,000 to develop a freeze drying technique for mRNA-based COVID-19 vaccines.
Patients treated with Imfinzi and chemotherapy experienced a 20 percent reduction in the risk of death versus chemotherapy alone.
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
Almost a third of unresectable hepatocellular carcinoma patients were alive at three years on tremelimumab and Imfinzi regimen.
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.