EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
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CAR-T therapy aids lupus remission
Researchers demonstrated promising early results for a personalised CAR T-cell therapy, which facilitated remission for lupus patients treated with the anti-CD19 treatment.
NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
FDA approves first gene therapy for Haemophilia B
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
First clinical trial to test novel heart attack drug
The first clinical trial for new heart attack drug glenzocimab, will evaluate its ability to reduce heart damage following a heart attack.
Clinical trials authorised for 3D-printed ulcerative colitis drug
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
Using UHPLC-MS/MS for trace detection of β-lactam antibiotics
Researchers demonstrate ultra high performance liquid chromatography with triple quadrupole mass spectrometry to detect and quantify trace amounts of cephapirin and ceftiofur.
Merck to acquire Imago for $1.35 billion
Merck has signed agreement to acquire Imago for $1.35 billion to further investigate potential of bomedemstat for myeloproliferative neoplasms and other bone marrow diseases.
FDA priority review for AbbVie lymphoma bispecific antibody
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
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.
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.
