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Radical innovation occurs when pharma looks outside its own world
Pharma executives are committed to bringing drugs to market to improve the lives of patients but is the industry too introspective to be truly innovative?
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US Food and Drug Administration (FDA)
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FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine as COVID-19 treatments
Following ongoing analysis and emerging scientific data, the FDA has taken away its emergency use authorisation for chloroquine and hydroxychloroquine, finding they are unlikely to be effective as COVID-19 treatments.
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New HIV drug formulation approved by FDA to treat paediatric patients
The FDA has approved Tivicay (dolutegravir) and Tivicay PD (dolutegravir) dispersible tablets to treat HIV in children at least four weeks old and weighing at least 3kg.
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Study suggests current drug shortages in US will be worsened by COVID-19 pandemic
A newly released paper has revealed that the shortages of medications in the US at present will be increased further due to the COVID-19 outbreak.
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FDA approves Recarbrio for treatment of bacterial pneumonias
Recarbrio (imipenem-cilastatin and relebactam) was approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
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Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
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Interim analysis indicates Auxora™ is effective in severe COVID-19 pneumonia patients
Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone.
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Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
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COVID-19 convalescent plasma therapy shown to be safe and effective
Scientists reveal 76 percent of critically ill trial participants treated with convalescent plasma are recovering, with almost half now discharged from hospital.
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Simple but effective: an experimental nanoparticle COVID-19 test
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
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FDA approves CYRAMZA® (ramucirumab) for EGFR-mutated non-small cell lung cancer
CYRAMZA in combination with erlotinib was approved as a first-line treatment for metastatic EGFR-mutated non-small cell lung cancer.
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FDA approves Phexxi™ vaginal gel for prevention of pregnancy
The US FDA approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) gel, the first non-hormonal, vaginal pH regulator contraceptive.
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FDA approves Lynparza (olaparib) for HRR mutated prostate cancer
Lynparza’s approval was based on results from a Phase III clinical trial in which it improved overall survival and progression-free survival in patients with certain prostate cancers.
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The COVID-19 pandemic and clinical trial disruptions
Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
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FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
