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.”
By January 2022, 12 billion COVID-19 vaccine doses had been manufactured and, to date, roughly 20 vaccines have received either full approval or emergency use authorization in countries around the world. In places such as Europe and the U.S., most of the people who want vaccinations have gotten their jabs. And the vaccines continue to show efficacy, with the latest CDC data showing consistently less risk for testing positive for COVID-19 or dying from the infection for those who are vaccinated and boostered. Yet the development of new COVID-19 vaccines remains surprisingly robust, with BioWorld tracking 258, the majority of which are in preclinical development.
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
As it settles a patent dispute with Japan’s Chugai Pharmaceutical Co. for $775 million, the U.K.’s Astrazeneca plc is looking to bring intellectual property in-house by snapping up a new generation of talented scientists.
