Tag: FDA

University of Oxford is currently studying ivermectin as a possible therapy against COVID-19 in the UK

Frank

UK – Researchers from the university of Oxford under the PRINCIPLE study project are currently giving Ivermectin, a widely used anti-parasitic drug, to over-50s with COVID symptoms to see if it can keep them out of hospital. PRINCIPLE is a nationwide clinical study from the University of Oxford in collaboration with the British government trying to find COVID-19 treatments for recovery at home. The project is currently having any willing citizen over-50s with an underlying health condition or experiencing breathlessness and have had COVID symptoms for up to 14 days…

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Boehringer Ingelheim’s Pradaxa approved by the FDA for oral pediatric use

Frank

USA – The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication suitable for children 12 years and below in the USA. The medication Pradaxa will be available for use for children with venous thromboembolism immediately after treatment with a blood thinner given by injection for at least five days. Venous thromboembolism (VTE) is a disorder that includes deep vein thrombosis and pulmonary embolism with deep vein thrombosis (DVT) occurring when a blood clot forms in a deep vein, usually in the…

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Bayer’s Astepro approved for over the counter use in the US

Frank

US – The US Food and Drug Administration (FDA) has approved Bayer’s steroid-free antihistamine nasal spray Astepro for over-the-counter use. Astepro becomes the first and only OTC steroid-free antihistamine nasal spray available in the US for adults and children aged six years and older. Currently, OTC allergy medications is classified into three major classes which include antihistamines, intranasal steroids and mast cell stabilizers. Bayer, a German multinational pharmaceutical and life sciences company had astepro previously approved for prescription use in 2008. Following the approval by the FDA, Astepro will be…

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Joseph Biden’s administration pumps in US$3.2bn for the development of a COVID-19 drug

Frank

US – The US government is taking another leap into the fight against COVID-19 through an investment worth US$3.2 billion to help develop antiviral therapy pills. This is part of the American Rescue Plan (ARP) government strategy to develop the next generation of COVID-19 treatments. ARP was developed to provide emergency grants, lending, and investment to hard-hit small businesses during the pandemic. This plan will provide more than $300 million for research and lab support, nearly $1 billion for preclinical and clinical evaluation, and nearly $700 million for development and…

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U.S. FDA greenlights supply of Janssen vaccine to bolster fight against COVID-19

Frank

US – The U.S Food and Drug Administration (FDA) has under the emergency authorization use (EUA), authorized the production of the Janssen (Johnson & Johnson) COVID-19 Vaccine for use in the United States. According to a statement from the FDA, the approval will allow the manufacture of two batches of the Vaccine by the Emergent BioSolutions, a facility in Baltimore. The move comes at a time when US president Joseph Biden and his Vice Kamala Harris are stepping up the fight against corona virus with clarion calls for more citizens…

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South Africa rolls back on FDA unwholesome-termed Johnson&Johnson COVID vaccines

Frank

SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has announced it will not release Johnson& Johnson(J&J) vaccines produced using the drug substance batches that were not suitable. South Africa, which is struggling to roll out its inoculation program as it enters a third wave of the pandemic, said it will pull two million of doses of the Johnson & Johnson vaccine following contamination concerns at one of the US drug maker’s sites. This follows an announcement made by the US Food and Drug Administration that millions of…

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Controversy surrounding Biogen’s newly approved Alzheimer’s drug costs FDA one more panelist

Frank

USA – A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said in his resignation letter that the agency’s decision on Biogen is probably the worst drug approval decision in recent U.S. history. “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to…

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FDA says no new Emergency Use Authorization will be approved for COVID vaccines

Frank

INDIA – Soon after Ocugen hit a major bump after FDA rejected emergency use authorisation (EUA) for Covaxin, Hyderabad-based Bharat Biotech has said that the USFDA had earlier communicated that no new Emergency Use Authorization (EUA) will be approved for Covid vaccines. The Pennsylvania-based eye disease company has had to change its application from an Emergency Use Authorization to a full Biologics License Applications (BLA) approval. Bharat Biotech said biological license application process is the standard process for vaccines This is setback that will potentially delay the launch of Bharat…

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Dr Reddy’s recalls 2,980 bottles of cholesterol lowering drug in US

Frank

INDIA – Drug major Dr Reddy’s Laboratories is recalling 2,980 bottles of Atorvastatin Calcium tablets in the US due to quality issues. Atorvastatin is indicated to lower cholesterol in the blood for adults and children over ten years of age. The drug is also prescribed to lower the risk of heart attack and stroke in patients with cardiovascular diseases, diabetes, and other risk factors such as eye problems, kidney diseases, or high blood pressure. As per the US Food and Drug Administration’s latest Enforcement report, the Hyderabad-based drug major is…

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Ghana goes herbal in health products as FDA trains practitioners on safety and efficacy

Frank

GHANA – The Bono, Bono East, and Ahafo Regions Office of the Food and Drugs Authority (FDA) has intensified measures to guarantee the safety and efficiency of herbal products for public consumption. The Authority has thus embarked on regional education, sensitization, and knowledge acquisition workshop for herbal medical practitioners in the three regions. Madam Akua Amponsaa Owusu, the Director in charge of the Authority for the three regions said about 180 herbal medicine practitioners in the Bono Region would be imparted with requisite knowledge about the herbal medicine manufacturing industry…

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