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FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
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Clinical Trials
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Enspryng® prevents relapse in over 70 percent of NMOSD patients
Enspryng (satralizumab) significantly reduced relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) in Phase III study.
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Ultrasound delivers antibody therapy for HER2-positive brain metastasis
MR-guided focused ultrasound safely delivered antibody therapy to breast cancer that has metastasised to the brain in Phase I study.
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Seventy percent of MS patients relapse-free with Zeposia®(ozanimod)
Zeposia® (ozanimod) also demonstrated a low annualised relapse rate (ARR) of 0.103 in the five-year Phase III DAYBREAK study.
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Influenza vaccine with COVID-19 booster shot shows positive results
Sanofi’s Fluzone® with Moderna’s COVID-19 mRNA investigational booster dose showed an immunogenicity response similar to individual doses.
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AZD7442 antibody combination reduces COVID-19 risk by 50 percent
AZD7442 is the first long acting antibody (LAAB) combination shown to prevent and treat severe COVID-19 infection in Phase III trial.
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Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
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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.
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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.
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Merck’s Keytruda®: update on trials and outcomes
EPR’s Anna Begley summarises some of the key results from trials of Merck’s Keytruda® (pembrolizumab) cancer treatment.
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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.
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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.
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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.
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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.
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Amlitelimab shows 80 percent improvement in atopic dermatitis
Late-breaking data highlights the emerging clinical profile of amlitelimab in adults with inadequately controlled atopic dermatitis.
