Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
It’s a time of economic crisis and political upheaval in the U.K. But, according to the country’s pharma trade body, there’s another looming problem of access to clinical trials in the country, which is becoming less and less attractive as a place to conduct life sciences research.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data.
GSK plc, formerly Glaxosmithkline plc, has begun a significant new chapter in its history with the spin-off this week of its consumer business known as Haleon plc. While the high-profile new listing of Weybridge, Surrey-based Haleon (LON:HLN), the largest in Europe in a decade, grabbed the headlines, investors are keeping a sharp eye on GSK now that it is free to focus on developing and marketing novel drugs.
Oxford Science Enterprises, an independent investor specializing in building companies through its relationship with the U.K.’s University of Oxford, has raised a further £250 million (US$300 million) to translate academic research into commercial products and businesses.
Oxford Science Enterprises, an independent investor specializing in building companies through its relationship with the U.K.’s University of Oxford, has raised a further £250 million (US$300 million) to translate academic research into commercial products and businesses.
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
