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.
ReutersThe 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.
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.
ReutersRegeneron 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.
Axsome Therapeutics said on Monday its experimental therapy cut the frequency of disruptive episodes of muscle weakness tied to a sleep disorder called narcolepsy in a late-stage trial.
The full approval makes Elahere the “first and only antibody-drug conjugate (ADC) approved in the U.S. for” ovarian cancer, a “difficult-to-treat malignancy,” AbbVie CMO of global therapeutics Roopal Thakkar, said in a statement.
The U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine.
