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Onivyde® improves survival in Phase III pancreatic cancer trial
Onivyde® (irinotecan liposome injection) treatment regimen significantly improved survival in a Phase III trial compared to nab-paclitaxel plus gemcitabine.
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EU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
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Personalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
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FDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
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MHRA authorises BRUKINSA® in Great Britain for two cancers
BRUKINSA® (zanubrutinib) has been authorised by the MHRA for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain.
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Clinical trial-first for liver cancer immunotherapy combo
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
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Amgen commits $8m to clinical trial diversity programme
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
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NICE recommends all-oral treatment for multiple myeloma
Ninlaro® (ixazomib) plus lenalidomide and dexamethasone has been recommended by NICE for relapsed/refractory multiple myeloma patients who have had two or three lines of therapy.
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Pfizer offers 1.2 billion in poorer countries access to full medicine portfolio
Pfizer has expanded its not-for-profit initiative ‘An Accord for a Healthier World’ to enable 45 lower-income countries access to its full product portfolio.
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UK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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UK ATMP clinical trials report 2022 published
T cells were revealed as the most commonly investigated cell type continuing to increase, found CGT Catapult's 2022 UK ATMP clinical trials report.
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MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Potential treatment identified for septic patients
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
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FDA approves long-acting injectable for schizophrenia and bipolar disorder
Schizophrenia and bipolar I disorder patients can be offered Rykindo® as a bi-weekly long-acting risperidone injection, as a result of the FDA's approval.
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Pharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
