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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.
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Therapeutics
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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.
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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.
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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.
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European Pharmaceutical Review Issue 5 2021
Articles in this issue discuss the importance of diversity and inclusion in pharma, how packaging can improve big pharma's bottom line and why innovation has been vital to saving lives during the COVID-19 pandemic. Also in this journal, 10 key considerations when creating an ATMP manufacturing facility and how to…
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Interferon treatment reduces leukaemia recurrence by 20 percent
Interferon treatment with a bone marrow transplant bolstered outcomes for patients with advanced, high-risk leukaemia.
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Imfinzi™ improves liver cancer survival in Phase III trial
Imfinzi (durvalumab) demonstrated a meaningful overall survival (OS) benefit versus sorafenib as a first-line treatment for liver cancer.
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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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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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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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Alnylam joins the Medicines Manufacturing Innovation Centre
Alnylam joins the third Grand Challenge (GC3) consortium to help overcome barriers to the manufacture of oligonucleotides.
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Mass spectrometry for gene therapy vector analysis
Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.
