FDA expands emergency use authorisation for remdesivir to treat all COVID-19 patients
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
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The new KORSCH X 3 tablet press: maximising mid-range production
The X 3 is a breakthrough in the small-scale and mid-range tablet press market segment and the latest advancement from KORSCH.
Study shows anticoagulation therapy beneficial for COVID-19 patients
Researchers have demonstrated that all regimens of anticoagulants were far superior to no anticoagulants in COVID-19 patients.
Further £8.4 million in funding given to UK researchers studying immune response to COVID-19
The funding is being split across three research projects that will hopefully improve the treatment of COVID-19 and inform the development of vaccines and therapeutics.
Blenrep granted CMA for relapsed or refractory multiple myeloma
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
First patients dosed in GSK’s Phase III meningitis vaccine trial
The trial will assess the safety, tolerability and immunogenicity of the five-in-one MenABCWY vaccine in participants aged 10 to 25.
Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
AstraZeneca doses first patients in COVID-19 therapy trial
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
AGGRASTAT® shows promise for treating COVID-19 thrombotic complications
According to Medicure, AGGRASTAT (tirofiban hydrochloride) has shown promise for preventing and treating thrombotic complications due to COVID-19.
FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
Collaboration to develop the world’s first prophylactic gonorrhoea vaccine
Therapyx and Intravacc will jointly develop NGoXIM, a microsphere vaccine which is designed to stimulate adaptive immunity against gonorrhoea.
First patients enrolled in Phase II trial of Novavax COVID-19 vaccine
The Phase II clinical trial to study NVX-CoV2373, the Novavax COVID-19 vaccine candidate, has enrolled its first patient.
India gives nod to cell therapy for Critical Limb Ischemia (CLI)
Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.
