Category: News
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Drug safety Alert – Benadryl and serious adverse events
The U.S. Food and Drug Administration (FDA) has released drug safety communication about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). Taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or even death. In the communication FDA stated “We…
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Sputnik-V trials results
The Lancet said the early-stage trials suggested the Sputnik-V vaccine produced a response in a component of the immune system known as T cells. Scientists have been scrutinising the role played by T cells in battling coronavirus infection, with recent findings showing these cells may provide longer-term protection than antibodies. [L1N2EH0X8] The Sputnik-V vaccine is…
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First-line treatment for bipolar disorder Priadel to be discontinued in UK from April 2021
The planned discontinuation of first-line bipolar disorder treatment Priadel has caused concern that some patients could relapse and face hospitalisation. The manufacturer of first-line bipolar disorder treatment Priadel is discontinuing production of the medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced — causing concerns that patients could relapse and face hospital admission. A supply disruption alert (SDA) issued by the MHRA on 21 August…
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Fournier Gangrene Associated with Sodium-Glucose Cotransporter-2 Inhibitors – study from FAERS data
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a relatively new drug category used for type 2 diabetes mellitus treatment in adults. They prohibit the normal functions of SGLT2, which are primarily expressed in the kidney, responsible for reabsorption of glucose from the glomerular filtration back into circulation, leading to urinary glucose excretion, thus lowering blood sugar. Unlike…
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Eli Lilly Begins Phase 3 Trial of Monoclonal Antibody for COVID-19 Prevention
Eli Lilly has begun a phase 3 trial of its monoclonal antibody LY-CoV555 for prevention of COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera, is a neutralizing IgG1 monoclonal antibody (mAb) against…
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FDA retires Medwatch to manufacturer program
The FDA has retired its MedWatch to Manufacturer Program as of July 31, 2020, in favor of the FDA Adverse Event Reporting System (FAERS). Created in 1993, the program had allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports submitted directly to the agency for new molecular…
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How close are we to a Coronavirus vaccine?
As per world health organization (WHO), more than 140 teams of researchers are racing to develop a safe and effective coronavirus vaccine. Vaccines normally require years of testing and additional time to produce at scale, but scientists are hoping to develop a coronavirus vaccine within 12 to 18 months. Vaccines mimic the virus – or…
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DCGI gives permission to SII-Oxford COVID-19 vaccine for phase 2, 3 clinical trials in India
The Drugs Controller General of India (DCGI), has given its permission to Serum Institute of India (SII) to conduct the phase 2 and phase 3 human clinical trials of a coronavirus vaccine which has been developed by the University of Oxford in India. The approval for the phase 2 and 3 human clinical trial of…
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RECOVERY trial from University of Oxford confirms benefits of dexamethasone in Covid-19
The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial led by the University of Oxford found that the use of dexamethasone resulted in lower 28-day mortality among those receiving either invasive mechanical ventilation or oxygen alone. However, there was “no clear effect” of dexamethasone for patients who were not receiving respiratory support. In the controlled, open-label trial,…
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New study reveals Oxford coronavirus vaccine produces strong immune response
A team of scientists at Oxford University’s Jenner Institute and Oxford Vaccine Group has taken the next step towards the discovery of a safe, effective and accessible vaccine against coronavirus. The results of the Phase I/II trial published today in the scientific journal, The Lancet, indicate no early safety concerns and induces strong immune responses in…