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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Advanced Biodesign starts first-in-human clinical trial targeting AML
After receiving an approval from France's National Agency for Medicinal Safety and Health Products (ANSM), Advanced BioDesign announced the enrolment of the first patient in its first-in-human clinical trial in acute myeloid leukaemia.
Edible sensor delivers real-time antiretroviral dosage data
HIV patients received real-time antiretroviral dosage data from an innovative edible sensor in a clinical trial.
NICE recommends new treatment for EGFR-positive lung cancer
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.
Could Astellas antibody be first-line treatment for gastric cancer?
Monoclonal antibody Zolbetuximab plus mFOLFOX6 achieved significant progression-free survival in a Phase III trial for advanced gastric and gastroesophageal junction cancers.
$145 million pharma acquisition to help launch opioid overdose drug
Indivior’s $145 million acquisition of Opiant Pharmaceuticals will support the launch of OPNT003, an opioid overdose reversal agent.
Big Pharma leading in access-to-medicine strategies, shows data
The 2022 Access to Medicine Index shows all 20 pharma companies have an over-arching access to medicine strategy, benefitting low and middle-income countries.
First implantable pump kills brain cancer using chemo
The first implantable pump system bypassed the blood-brain barrier to deliver chemotherapy to brain cancer patients in a Phase I study.
First-in-class oral antibiotic improves tuberculosis
GSK’s low dose, daily oral antitubercular agent improved drug-susceptible pulmonary tuberculosis after 14 days, giving it potential as a simpler treatment option.
2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
EMA human medicines committee (CHMP) highlights, November 2022
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.
First oral treatment approved for post-transplant refractory cytomegalovirus
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
QA of prostaglandin analogues for glaucoma treatment
Paper highlights trends in developing analytical procedures to assess the quality of prostaglandin analogues used to treat glaucoma.
Minoryx and Neuraxpharm team to provide new therapy for rare CNS disorders
Minoryx Therapeutics and the Neuraxpharm Group enter into a license agreement for the European rights to leriglitazone, which is currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD).
