Neuralink ‘Blindsight’ Brain Implant Gets FDA ‘Breakthrough Device’ Nod
The device is a variant of Neuralink's brain implant technology, in this case designed to "enable even those who have lost both eyes" to see, according to owner Elon Musk. Separately, progress is reported in a gene therapy program to beat macular degeneration.
Reuters:
Musk's Neuralink Gets FDA's Breakthrough Device Tag For 'Blindsight' Implant
Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration's "breakthrough device" designation. The experimental device, known as Blindsight, "will enable even those who have lost both eyes and their optic nerve to see," Musk said in a post on X. (9/18)
Stat:
4D Molecular: Positive Data For Macular Degeneration Gene Therapy
A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up. On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. (Mast, 9/18)
USA Today:
What Is Myopia? Experts Now Calling Nearsightedness A Disease
More than 40% of Americans are estimated to have myopia, also known as nearsightedness. While many may consider it a minor inconvenience easily remedied with glasses, authors of a report published Tuesday are calling on health agencies to classify it as a disease. Committee members at the National Academies of Science, Engineering and Medicine say nearsightedness has become an “evolving epidemic” that requires more research, standardization of care and early prevention, recommending at least one hour of outdoor time daily for kids. (Rodriguez, 9/19)
On weight loss drugs —
Reuters:
Hims & Hers Offers Compounded Wegovy For $99 A Month To Select Professions
U.S. telehealth company Hims & Hers Health on Wednesday said it will sell compounded versions of Novo Nordisk's popular weight-loss drug Wegovy to patients in certain professions for $99 a month. The company said the pricing would be available to eligible U.S. military members, teachers, nurses and first responders, including police and firefighters, as well as veterans. ... Novo and rival Eli Lilly, which makes the weight-loss drug Zepbound, have filed a flurry of lawsuits against medical spas, wellness clinics and compounding pharmacies for allegedly selling products claiming to contain the active ingredients in their drugs. Compounded GLP-1 injections are fulfilled and shipped from Hims & Hers' affiliated pharmacies and are FDA-regulated, the company said. (Niasse, 9/18)
CNN:
GLP-1 Drugs Could Help Prevent 34,000 Heart Attacks And Strokes In The US Each Year, Research Suggests
Certain blockbuster weight-loss drugs have been found to protect the heart in significant ways, and new research suggests that the cardiovascular benefits could extend to an even broader set of patients than clinical trial data has shown – helping prevent tens of thousands of heart attacks and strokes each year in the United States. (McPhillips, 9/18)
Stat:
Corbus Sees Novo’s Controversial Obesity Approach As A Ticket To A Blockbuster
Nearly two decades ago, European regulators pulled an obesity drug called rimonabant off the market due to concerns it was tied to suicidal ideation. Now, a small handful of companies are developing drugs that use a similar approach to the discarded treatment, which involves inhibiting type 1 cannabinoid receptors, or CB1 receptors. (Chen, 9/19)
More pharmaceutical updates —
Reuters:
A Second Zantac Cancer Trial Ends With Hung Jury
The latest trial over claims that the discontinued heartburn drug Zantac causes cancer ended with a hung jury on Wednesday, as jurors in Chicago were unable to agree on whether Boehringer Ingelheim must pay damages to an Illinois man who said he developed prostate cancer as a result of taking the drug, according to the man's lawyer. It was the second time a jury failed to reach a verdict at trial during the ongoing wave of litigation over the now-discontinued drug. (Pierson, 9/18)
Stat:
Colon Cancer Blood Test Competition Spills Over To Social Media
Biotech companies routinely compete to develop and commercialize products. But these rivalries are seldom as publicly heated as what has played out on social media this week between two firms racing to develop new ways to screen for colon cancer. (Wosen, 9/18)
Reuters:
ICU Medical Recalls Tubes Used In Tracheostomy Due To Manufacturing Defect
The U.S. Food and Drug Administration, on Wednesday, classified the recall of certain tubes made by a unit of ICU Medical as the most serious type, which could cause severe injury or death. Specific lots of the tubes sold under the Bivona brand by ICU's unit Smiths Medical for neonatal or pediatric and adult patients are being recalled due to a manufacturing defect, opens new tab that may cause the device's securement flange to tear. (9/18)
