β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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EU adopts electronic product information standard for medicines
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
Recommendations published on medicine procurement across the EU
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.
Pharmaceutical industry seeks to build public trust with new data principles
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.
COPAXONE® label updated to help breastfeeding mothers with relapsing MS
The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
Pistoia Alliance launches Women in STEM leadership pilot
A new collaborative initiative involving 15 large pharma companies will support diversity in executive roles and cross-company leadership skills development.
Coalition formed to tackle ‘hidden pandemic’ of antibiotic resistant infections
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.
FDA aims to advance non-addictive opioid alternatives for acute pain management
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.
Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility.
NICE approves Wegovy™ (semaglutide) for obesity
New draft guidance means thousands of obese Brits could benefit from Novo Nordisk’s Wegovy™ (semaglutide), a drug shown to improve weight loss.
DARWIN EU® Coordination Centre to integrate real-world evidence into medicines regulation
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
NICE recommends first treatment for children with metachromatic leukodystrophy
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
New regulation strengthens role of EMA in EU crisis response
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.
Lab automation systems market to value $6.4bn
Laboratory automation systems are gaining popularity as they expedite and streamline processes, improving product quality while reducing human error.
Cabenuva HIV treatment approved for eight week dosing
US FDA approves Cabenuva (cabotegravir, rilpivirine) based on results from the ATLAS-2M Phase IIIb trial which showed every-two-month dosing was non-inferior to once-monthly dosing.
