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Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
Investing $700mn to establish a new site, Eli Lilly plans to fuel the development of genetic medicines through the company’s new Institute for Genetic Medicine.
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
A new framework for how the pharmaceutical industry will use health data for research and development of cutting-edge new medicines has opened for consultation.
The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
A new collaborative initiative involving 15 large pharma companies will support diversity in executive roles and cross-company leadership skills development.
A White Paper launched by a coalition of partners spanning pharmaceuticals, MedTech and diagnostics, calls for a transformational change in the way infection is detected, monitored, prevented and managed across all facets of the NHS, healthcare systems and broader society.
The U.S. Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility.
New draft guidance means thousands of obese Brits could benefit from Novo Nordisk’s Wegovy™ (semaglutide), a drug shown to improve weight loss.
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
