AstraZeneca’s Ultomiris wins FDA approval for rare autoimmune disease
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
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AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
The early-stage study showed that Viking Therapeutics’ oral obesity candidate VK2735, a dual agonist of the GLP-1 and GIP receptors, elicited a 3.3% reduction in mean body weight. The company plans to start a Phase II trial.
A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.
The company said it has identified “material weakness in its internal control over financial reporting”, which resulted in ineffective disclosure of controls and procedures.
The U.S. Supreme Court on Tuesday is poised to consider whether to restrict access to the abortion pill as President Joe Biden’s administration fights to maintain broad access to the medication in a major case that thrusts reproductive rights back on the agenda of the justices in a presidential election year.
The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
A consistent theme from SXSW is the downturn of brand advertising. Consumers don’t want to feel marketed to but are open to content that is entertaining or provides some value exchange. Value is not a new concept, as content marketing has been a consistent tactic for a long time. But more often we see consumers’ ability to block or tune out brand content. Couple this with the fact that content looks much different than it did even a few years ago, and it’s clear that this is an area where pharma needs to innovate.
AbbVie Inc. and Landos Biopharma, Inc. today announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family) with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates epithelial repair.
Regeneron Pharmaceuticals said the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma, raising concerns over the progress of ongoing confirmatory trials.
The combo pill is indicated for chronic use in pulmonary arterial hypertension (PAH) patients falling under the World Health Organization’s functional classes II to III. These classes include patients who may have no symptoms at rest but experience shortness of breath or discomfort during normal activities such as climbing stairs or running errands.