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EMA evaluate booster dose of COVID-19 vaccine Spikevax
The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.
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Drug Safety
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Taletrectinib displays 90.5 percent objective response rate in NSCLC
Innovent Biologics and AnHeart Therapeutics jointly announced the interim clinical data from a Phase II trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). The data was announced at the Chinese Society of Clinical Oncology (CSCO) 2021. Taletrectinib is an investigational next-generation…
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Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
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Lynparza® with abiraterone delays prostate cancer progression
Lynparza with abiraterone is the first PARP inhibitor to demonstrate clinical benefit in combination with a hormonal agent in this setting.
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Babies with SMA able to swallow with Evrysdi® treatment
All five pre-symptomatic babies with spinal muscular atrophy (SMA) were able to swallow and feed orally after 12 months of treatment.
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New radionuclides network to revolutionise nuclear medicine and molecular imaging
The European PRISMAP consortium will provide access to novel radioisotopes for medical research and promote the development of new radio-medicinal products.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
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Temperature stable microneedle patch successfully delivers DNA COVID-19 vaccine
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
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Veklury® (remdesivir) reduces COVID-19 hospitalisation risk by 87 percent
Veklury (remdesivir) significantly reduced the risk of COVID-19 related hospitalisation and death in high-risk patients in Phase III study.
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J&J vaccine booster dose displays 94 percent protection
Johnson & Johnson announced Phase III data demonstrating effective COVID-19 protection and an increase in protection with a booster dose.
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Xtandi® reduces prostate cancer death risk by 34 percent
Xtandi reduced the risk of death by 34 percent in men with metastatic hormone sensitive prostate cancer in a Phase III study.
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Comirnaty® effective in children aged five to 11 years
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
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Imfinzi™ plus chemotherapy triples small cell lung cancer survival
Roughly 17.6 percent of patients treated with Imfinzi plus chemotherapy were alive at three years, versus 5.8 percent of chemotherapy patients.
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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.
