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Microglia and myelin

Open label: Extension of PDUFA less troubling as TG’s ublituximab makes headway in regulatory talks

Nov. 11, 2022
By Randy Osborne
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
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NeuroRestore Vsx wireless implantable pulse generator operating in closed loop

Researchers identify neurons that enable paralyzed patients to walk again

Nov. 10, 2022
By Annette Boyle
Researchers at the Neurorestore research center created a device that allows paralyzed patients with no sensation in their legs to walk again, providing hope for others with complete spinal injury. More remarkably, the team discovered the specific neurons that take over the signaling function between the brain and muscles to permit movement in response to the device’s electrical stimulation, offering a path forward for researchers, clinicians and patients affected by a wide range of neurological disorders.
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Cardiovascular illustration

PADding the results at VIVA22

Nov. 8, 2022
By Annette Boyle
The 2022 Vascular Interventional Advances (VIVA) medical meeting, which concluded on Nov. 3 in Las Vegas, focused on advances in interventional cardiology and devices to improve vascular health with the expected studies comparing drug-eluting balloons, new stents and less invasive procedures. One Boston Scientific Corp. presentation put the rest into context, however, with one of the most critical advances in cardiology, enrollment in the Drug-Eluting Registry: Real World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE) registry.
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AHA Scientific Sessions 2022

PROGRESSIVE-AF adds to the argument for ablation-first strategy for atrial fibrillation

Nov. 8, 2022
By Mark McCarty
Few disease states in the world of cardiology have been studied as persistently as atrial fibrillation (AF), but new study data presented in Chicago at the 2022 scientific sessions of the American Heart Association seem to advance the cause of an ablation-first strategy for some patients experiencing paroxysmal AF. The PROGRESSIVE-AF study demonstrated that patients who are ablated early in the disease cycle are less likely than those placed on drug management to experience recurrence and to be readmitted, just two of several findings that are driving cardiologists toward device therapy and away from drug therapy for their patients with AF.
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