Year: 2022
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Turkish Pharmaceuticals and Medical Devices Authority (TITCK) – Pharmacovigilance guidelines Updates
On 20 Jun 2022, the TITCK published the guidelines to Good Pharmacovigilance (IFU) Module X and Module Xi – pre marketing Benefit/Risk assessment and Post marketing benefit/Risk assessment respectively. New Updates: Module X: Pre-marketing benefit/risk assessment Guideline The acceptable benefits and risks should be briefly summarized along with the background of the disease, the course…
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Withdrawal of lymphoma medicine Ukoniq (umbralisib)
Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death…
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Next Generation Drug Safety
Medicines are chemicals or compounds used to cure, halt, or prevent disease; ease symptoms; or help in the diagnosis of illnesses. Though these medicine appears to be safe and well tolerated there is significant risk associated with them. The risks need to be balanced against their benefits and only medicines with a positive benefit-risk balance…
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Phase 3 results of Bharat Biotech inactivated SARS-CoV-2 vaccine
The results of the phase 3 controlled and randomized study of the BBV152 anti COVID-19 vaccine made entirely in India have been published in the Lancet. It is a traditional adenovirus vaccine that has the advantage of being stored at temperatures of up to 8 degrees. 25,798 participants randomized to the vaccine or placebo were…
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Pulmonary toxicity from simvastatin
Simvastatin therapy may be associated with rare cases of interstitial lung disease. This is suggested by a retrospective study conducted on 34 patients with suspected pulmonary toxicity from simvastatin, which investigated the role of pharmacogenetic factors and concomitant therapies in the development of this syndrome.In 70.5% of cases, pulmonary toxicity was due to the use…