Month: September 2020
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Eli Lilly’s Investigational Antibody Shows Promise as Outpatient COVID-19 Treatment
Eli Lilly has announced positive results from a phase 2 trial of its investigational antibody treatment LY-CoV555 as an outpatient treatment for mild-to-moderate COVID-19. Most patients who received a 2,800-mg dose of the antibody demonstrated near-complete viral clearance after 11 days, the company said. The trial enrolled just over 450 patients who either received a…
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TGA Recall alert: Bufexamac
The Therapeutic Goods Administration (TGA) advised consumers and health professionals that first aid creams containing bufexamac will be removed from the Australian Register of Therapeutic Goods (ARTG) on 18 September 2020 and will no longer be sold in Australia. Bufexamac is associated with a risk of serious skin reactions (also known as allergic contact dermatitis).…
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Russia Chooses Dr. Reddy’s to Distribute COVID-19 Vaccine in India
The Russian Direct Investment Fund (RDIF) has partnered with Dr. Reddy’s to distribute Russia’s Sputnik V COVID-19 vaccine in India. Under the agreement, Dr. Reddy’s will also collaborate with RDIF on clinical trials of the vaccine in India. Upon its approval by India’s regulatory authority, RDIF will supply Dr. Reddy’s with 100 million doses for…
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Health Canada approves Merck’s Enbrel Biosimilar
Health Canada has approved Merck’s Brenzys (etanercept injection), a biosimilar to Amgen’s Enbrel for four new indications aimed at plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis. The biosimilar is now approved for adults with chronic moderate-to-severe plaque psoriasis and for reducing signs and symptoms of psoriatic arthritis. It is also approved for chronic severe…
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Risk of serious liver injury associated with the use of Fibristal – Health Canada Advisory notice
Fibristal (ulipristal acetate) is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (uterine fibroids) in women of childbearing age. The Department is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to…
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CHINA: NMPA New guidelines on the Submission of the Periodic Risk Assessment Reports
Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to the National Medical Products Administration (NMPA). The Periodic Risk Assessment Report is needed to describe the likelihood, consequences and tolerances of the possible risks of using a device. They will…
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FDA Warns That Tecentriq and Paclitaxel Combination Doesn’t Work for Breast Cancer
The FDA warned that Roche’s Tecentriq (atezolizumab) and paclitaxel did not work as a treatment for previously untreated inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC). In a phase 3 trial, the combination did not significantly reduce the risk of cancer progression and death compared with a placebo and paclitaxel in mTNBC patients whose…
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MHRA Issues Alert on insomnia drug labelling issue
The UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) has issued a warning about the labeling on generic forms of the insomnia drug zoplicone manufactured by Mylan and Ratiopharm UK that fails to disclose possible suicide risks. MHRA noted that the Patient Information Leaflet and the Summary of Product Characteristics were supposed to warn of…
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Soft coding and effects on safety Signal
Signal detection and its assessment is the most important aspect in pharmacovigilance which plays a key role in ensuring that patients receive safe drugs. The detection of unknown and unexpected safety signals as early as possible is critical in pharmacovigilance. The definition of a signal as provided by the Council for International Organizations of Medical…
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Resume of AstraZeneca Covid-19 vaccine clinical trials in UK
Phase three trials for AstraZeneca’s coronavirus vaccine have resumed in the U.K. after they were halted earlier this week over safety concerns, the company announced Saturday. AstraZeneca said it received confirmation from the United Kingdom’s Medicines Health Regulatory Authority that it was safe to resume clinical trials. The company declined to disclose medical information about the pause of…