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Could GSK offer the first RSV older adult vaccine?
The EMA has accepted a marketing application for an RSV vaccine intended for older adults, the first potential vaccine for this age group with lower respiratory tract disease.
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Clinical Development
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$8 million grant awarded to new US stem cell clinic
New US stem cell clinics given an $8 million grant will boost industry collaboration and advance regenerative medicine research, clinical trials and pioneering training.
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EMA validates AbbVie lymphoma bispecific antibody application
AbbVie's marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
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First patient receives new engineered mRNA epigenetic
OTX-2002, a programmable epigenetic medicine is the first mRNA therapy to target MYC dysregulation and could treat hepatocellular carcinoma.
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NICE recommends first oral GnRH antagonist for uterine fibroids
Ryeqo, a one-per-day oral drug for adults with moderate-to-severe symptoms of uterine fibroids has been given the green light by NICE.
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AstraZeneca dual immunotherapy approved for US liver cancer patients
The FDA has approved Imfinzi™ combined with Imjudo for adults with unresectable liver cancer, based on a lower risk of death compared to only sorafenib.
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Gilead and MacroGenics to develop bispecific cancer antibodies
A collaboration agreement between Gilead and biopharma company MacroGenics aims to develop MGD024, a bispecific antibody for treatment of blood cancers.
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Shingles vaccine offers a decade of protection in older adults
Shingrix can effectively vaccinate adults over 50 years old against shingles for at least 10 years, new data shows.
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$38 million will fund rare disease research over four-year period
Research for rare diseases including ALS will be supported over the next four years by $38 million in FDA funding.
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Enterin and Parkinson’s UK to partner on dementia study
A new Phase II trial will study the drug ENT-01 for Parkinson’s Disease (PD)-associated dementia at sites in the UK and US.
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Astellas reports effectiveness of potential treatment for VMS
Results from a clinical study by Astellas have demonstrated the effectiveness of fezolinetant as a treatment for menopause-associated VMS.
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Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
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First FDA pregnancy-approved Pertussis vaccine to protect newborns
The FDA has approved Boostrix, the first vaccine for pregnant women in their third trimester, to stop whooping cough (Pertussis) in infants below two months.
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Novel cancer therapeutic synthesised by Stanford researchers
The natural compound tigilanol tiglate was produced in a lab for the first time by scientists at Stanford University, suggesting it could provide treatment for a variety of cancers.
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Cystic fibrosis phage therapy trial commences
The National Institute of Allergy and Infectious Diseases (NIAID)-supported clinical trial will assess whether the bacteriophage therapy WRAIR-PAM-CF1 safely reduces the quantity of Pseudomonas aeruginos bacteria in fibrocystic lungs.
