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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.
The first clinical trial for new heart attack drug glenzocimab, will evaluate its ability to reduce heart damage following a heart attack.
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
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.
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The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
The US Food & Drug Administration (FDA) has approved the first-in-human gene therapy trial for heart failure patients with preserved ejection fraction.
No new antibiotic class has reached market since 1987, despite 227,808 papers published since WHO released its priority pathogens list, finds study.
HIV patients received real-time antiretroviral dosage data from an innovative edible sensor in a clinical trial.
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 2022 Access to Medicine Index shows all 20 pharma companies have an over-arching access to medicine strategy, benefitting low and middle-income countries.
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.
