EMA’s human medicines committee (CHMP) September meeting highlights
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
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Kisqali® demonstrates longest overall median breast cancer survival
Kisqali plus letrozole achieved a median overall survival of over five years, the longest ever reported for HR+/HER2 breast cancer.
Trodelvy® improves breast cancer survival and quality of life
Trodelvy significantly improved overall survival and demonstrated clinically meaningful improvements in quality of life in Phase III study.
Sotorasib plus panitumumab shows efficacy against colorectal cancer
Sotorasib combined with panitumumab displayed 27 percent response rate against colorectal cancer in Phase I/II trial.
Ampion™ reduces severe knee osteoarthritis pain in 12 weeks
Ampion significantly reduced pain and improved function in severe osteoarthritis of the knee (OAK) in 12 weeks, shows Phase III study.
COVID-19 Vaccine Moderna effective against variants of concern
New data shows that Moderna’s COVID-19 vaccine protects against variants of concern and reduces breakthrough infection risk.
Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
Opdivo® and Yervoy® combo increases mesothelioma survival
Opdivo and Yervoy displayed a 23 percent survival rate at three years compared to 15 percent with chemotherapy, Phase III trial shows.
Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
US government purchases additional 1.4 million doses of REGEN-COV™
Regeneron announced a new US government agreement to purchase additional doses of REGEN-COV (casirivimab and imdevimab) antibody cocktail.
J&J’s Ebola vaccine regimen demonstrates immune response
Johnson & Johnson’s Ebola vaccine regimen, Zabdeno® and Mvabea®, generated robust humoral immune responses in adults and children.
Viral vector purification market expected to reach over $1 billion by 2028
New research suggests the viral vector purification market will attain a compound annual growth rate of 14.2 percent between 2021 and 2028.
Could amphibian foam be the future of topical drug delivery?
According to researchers, amphibian foam from the nests of the túngara frog could revolutionise topical, vaginal and rectal drug delivery.
Neoadjuvant atezolizumab combination meets safety criteria in pleural mesothelioma
Neoadjuvant cisplatin and pemetrexed in combination with atezolizumab met safety criteria in resectable pleural mesothelioma clinical study.