EMA review for GSK, Vir's COVID-19 antibody launched | Report: EU may not renew AstraZeneca, J&J vaccine deals | Chinese may approve Pfizer/BioNTech vaccine this summer
April 20, 2021
News on diagnostic and therapeutic innovations and regulatory science
A review has been initiated by the European Medicines Agency for VIR-7831, the investigational monoclonal antibody co-developed by GlaxoSmithKline and Vir Biotechnology as an early treatment for COVID-19. Included in the review will be an interim analysis of safety and efficacy data for 583 randomized patients, which showed the treatment reduced hospitalization or mortality by 85% in participants who received the monoclonal antibody in comparison to those given a placebo.
The European Commission reportedly will not renew its COVID-19 vaccine contracts with AstraZeneca and Johnson & Johnson when they expire at the end of the year over concerns about blood clots and delivery disruptions, according to an Italian health official quoted in La Stampa. However, a European Commission spokesperson said the bloc is keeping all options open.
Chinese health regulators are reportedly considering approval of the Pfizer/BioNTech COVID-19 vaccine this summer, which would be the first Western vaccine approved by the country. About 100 million doses are expected to be delivered to China by the end of the year through a deal with BioNTech and Shanghai Fosun Pharmaceutical Group Co.
India is delaying its contributions to the global vaccine-sharing initiative COVAX as an outbreak in COVID-19 cases is leading to shortages in some Indian states. India is the world's largest vaccine producer and was providing doses of the AstraZeneca/Oxford vaccine manufactured by the Serum Institute of India.
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Mayne Pharma has gained the FDA's approval for its contraceptive Nextstellis, or drospirenone and estetrol, which is expected to become commercially available by the end of June.
The FDA has revoked the emergency use authorization granted to Eli Lilly and Co.'s monoclonal antibody drug bamlanivimab as a standalone therapy against COVID-19 due to the emergence of variants resistant to the drug, just hours after Eli Lilly made the request. The agency said the benefits of using bamlanivimab alone "no longer outweigh the known and potential risks for its authorized use."
The Centers for Disease Control and Prevention could decide by Friday if restrictions will be added to the Johnson & Johnson vaccine after six women reported blood clotting issues after receiving the shot, according to Dr. Anthony Fauci. The US paused use of J&J's vaccines last week.
Wealthy countries must donate excess doses of COVID-19 vaccines to the World Health Organization's COVAX initiative for distribution in less developed countries, officials urged this week, noting many poor countries had yet to receive a single dose of the vaccines. Europe this week surpassed one million coronavirus-related deaths, and WHO Director-General Dr. Tedros Adhanom Ghebreyesus warns new cases are nearing the highest level seen since the pandemic began.
What life sciences developments will be talked about this year? Who will you meet? There's no telling -- well, maybe there is -- with the official release of the DIA 2021 Global Annual Meeting Program!
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Further your career and advance your current skillset with DIA virtual events this year. DIA events help professionals to stay on top of policy changes, best practices, and updated guidances through interactive workshops, engaging sessions, and networking event -- now held on your device anywhere in the world. Check out our upcoming, can't-miss conferences and trainings for healthcare and life sciences professionals to take yourself to the next level:
