Therapeutic-first for cold agglutinin disease haemolytic anaemia
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
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First-in-human gene therapy trial for major cardiac syndrome
The US Food & Drug Administration (FDA) has approved the first-in-human gene therapy trial for heart failure patients with preserved ejection fraction.
The race for a new class of antibiotics
No new antibiotic class has reached market since 1987, despite 227,808 papers published since WHO released its priority pathogens list, finds study.
First COVID-19 impact report on global vaccine markets
A 2022 WHO report is the first to portray COVID-19’s impact on the global vaccine market, identifying that lower-income countries struggle to access critical vaccines.
FDA approves first drug to delay type 1 diabetes
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
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.
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.
