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Adjupanrix, a pandemic influenza vaccine (split virion, inactivated, adjuvanted) manufactured by GSK, has been reserved for future manufacturing and supply under a framework agreement with the European Commission's (EC) Health Emergency Preparedness and Response Authority (HERA). Influenza pandemics, which are caused...

A third workplan with measures due by 2025 has been released by the joint Big Data Steering Group of the European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA). The new strategy, according to EMA, will...

Indian pharmaceutical exports increased by 8% in the first quarter of the current fiscal year to $6.26 billion, with officials anticipating a 10% increase by year's end. Pharma exports to the European Union and other CIS countries, which were affected...

Adenine base editors were successfully created by GenKOre, a biotech startup in South Korea, using its unique hypercompact gene-editing method. The hypercompact ABEs created by GenKOre are distinguished by their small size, ability to be delivered via an adeno-associated virus...

Real-world evidence (RWE) should be included in regulatory decision-making, according to a declaration backed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The International Coalition of Medicines Regulatory Authorities (ICMRA) released a...

According to a paper examining the present environment for antimicrobial development in Brazil, India, and South Africa, lowering regulatory barriers to hasten the clearance of novel antibiotics will aid in the development and accessibility of those drugs. Given that antibiotics...

The FDA has given the go-ahead to the Serum Institute of India (SII) to eventually supply a COVID-19 vaccine to the U.S. with Novavax's Nuvaxovid. The emergency use authorization granted to Novavax's recombinant protein-based vaccination on July 13th means SII...