The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
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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New draft guidance means thousands of obese Brits could benefit from Novo Nordisk’s Wegovy™ (semaglutide), a drug shown to improve weight loss.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.
Laboratory automation systems are gaining popularity as they expedite and streamline processes, improving product quality while reducing human error.
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.
According to Takeda, its new strategic leadership changes will ensure the continued growth and competitiveness of the company.
Transiently infecting tobacco plants, researchers were able to produce recombinant proteins that could be developed into COVID-19 vaccines.
Dr William Pao will assume his role as Executive Vice President and Chief Development Officer at Pfizer in March 2022, replaced at Roche by Dr Hans Clevers.
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.