No Emergency Use Listing approval for Covaxin yet, more clarifications needed

SWITZERLAND – The World Health Organization’s technical advisory group requested “additional clarifications” from Bharat Biotech on Tuesday for its COVID-19 vaccine Covaxin in order to conduct a final “risk-benefit assessment” for the vaccine’s Emergency Use Listing. The technical advisory group will now meet on November 3 to conduct a final evaluation. The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that advises WHO on whether or not a Covid 19 vaccine should be listed for emergency use under the EUL procedure. Bharat Biotech has been…

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WHO’s advisory group to deliberate on Covaxin EUL approval

SWITZERLAND – The World Health Organization (WHO) has announced that experts will meet on October 26 to decide whether to grant emergency use status to Bharat Biotech’s Covid-19 vaccine Covaxin. Harsh Vardhan Shringla, India’s foreign secretary, expressed optimism that the WHO will soon approve Hyderabad-based Bharat Biotech’s Covid vaccine Covaxin. “It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come…

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WHO releases recommendations for robust healthcare delivery post-covid

SWITZERLAND – The World Health Organization (WHO) in a novel paper has identified seven critical areas that must be strengthened in order to improve health services worldwide. Throughout the COVID-19 pandemic, health services were exhausted and stretched far beyond their capacity; now, the World Health Organization has released its seven recommendations for ensuring the future of health systems in the aftermath of the last two years of devastation. The WHO believes that this effort will help to accelerate the implementation of the International Health Regulations (2005), advancing health systems toward…

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Reprieve for international travelers as US OK’s mixed COVID-19 vaccine doses

USA – The United States’ national public-health agency has announced that travelers who have received doses of different COVID-19 vaccines will now be considered fully vaccinated, paving the way for foreigners to enter the United States under new rules that go into effect in November. The Centers for Disease Control and Prevention (CDC) has also announced that it had updated its guidance to state that anyone who receives a mixed dose of COVID-19 vaccines will be considered inoculated. The inoculation status will be valid as long as the vaccines are…

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FDA clears Eli Lilly’s Verzenio for treatment of early breast cancer

USA – The Food and Drug Administration (FDA) has given a positive nod to abemaciclib (Verzenio) in combination with endocrine therapy for adjuvant treatment of certain patients with early breast cancer. The approval applies to use of the agent by adults with hormone receptor-positive, HER2-negative, node-positive disease at high risk for recurrence who have a Ki-67 score of at least 20% as determined by an FDA-approved test. The FDA noted in announcing the approval that the oral Cyclin Dependent Kinase 4/6 (CDK 4/6) inhibitor is the first to be approved…

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EU proposes reforms for general pharma legislation

EUROPE – The EU Commission has proposed reforms to the general pharmaceutical laws that seek to ensure a future-proof and crisis-resistant medicines regulatory system. The review of the EU’s general pharmaceutical legislation is a key component of the European Commission’s pharmaceutical strategy, released in November 2020. In its review, the Commission is looking at potential reforms in a variety of areas, including unmet medical needs, improving access to and affordability of medicines, addressing antimicrobial resistance, ensuring the security of medicine supply, adapting the regulatory approach to account for “novel products,”…

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Medtronic’s AI surgery machine gets EU CE mark approval

IRELAND – Medtronic plc, the global leader in medical technology, announced today that the Hugo robotic-assisted surgery (RAS) system has received CE (Conformité Européenne) mark, allowing it to be sold in Europe. CE Mark approval is only available for urologic and gynecologic procedures, which account for roughly half of all robotic procedures performed today. Hugo RAS system plays a critical role in bringing the benefits of minimally invasive surgery, the first-ever in the world using the Hugo RAS system. CE Mark approval follows major milestones in the Hugo RAS system global…

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WHO “deeply concerned” over Emergency Use Listing vaccines row

UNITED NATIONS – The World Health Organization has state that it is “deeply concerned” that Covid-19 vaccines, which have proven to be effective and have been approved by the global health body for emergency use, are not being recognized in all countries. Addressing a press briefing, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, said the organisation again calls on “all countries to ensure the recognition of vaccines proven to be efficacious and safe and certainly that meet WHO Emergency Use Listing criteria.” On the…

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African Medicines Agency set in motion following 15 enactments from member states

GABON – The Republic of Gabon has become the 14th member state to deposit the instrument of ratification of the African Medicines Agency (AMA) to the AU Commission  after endorsing it on the 1st October 2021. The African Medicines Agency (AMA) is a proposed specialized agency of the African Union (AU) intended to facilitate the harmonization of medical regulation throughout the African Union. AMA aims to provide support for the improvement of weak regulatory systems. AMA will, among other functions, coordinate and strengthen ongoing initiatives to harmonize medical products regulation…

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SAPHRA approves Neoteryx’s Mitra devices for blood specimen collection

SOUTH AFRICA – The Mitra micro sampling device from US-based Neoteryx has been approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa. Separations, a South African-based distributor of devices and products for scientists and labs, helped get the Mitra device approved for broad use in South Africa. Class B registration allows lay people to use the Mitra to self-sample at home for research studies or monitoring non-critical conditions. The Mitra device is ideal for remote use…

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