MHRA approves first gene therapy for infusion into the brain
Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
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Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.
Monoclonal antibody Zolbetuximab plus mFOLFOX6 achieved significant progression-free survival in a Phase III trial for advanced gastric and gastroesophageal junction cancers.
The first implantable pump system bypassed the blood-brain barrier to deliver chemotherapy to brain cancer patients in a Phase I study.
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
GSK’s low dose, daily oral antitubercular agent improved drug-susceptible pulmonary tuberculosis after 14 days, giving it potential as a simpler treatment option.
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.
Alternative CAR-T and cell therapies increased relapsed multiple myeloma patient survival by 18 months after failed CAR-T, a study found.
According to a new study, 25mg of psilocybin alongside psychological support, greatly reduces symptoms in participants with treatment-resistant depression.
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.