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FDA approves first gene therapy for inherited deafness, shown to restore hearing for children with rare condition

Kraig Pakulski 0 11 Article rating: No rating

By Meg Tirrell, CNN

(CNN) — The US Food and Drug Administration on Thursday approved the first gene therapy for inherited hearing loss, a one-time treatment that proved to be life-changing for a small number of children in a clinical trial who were born without hearing.

The condition it treats is rare, affecting up to about 50 babies born each year in the US with mutations in a gene known as OTOF. But the therapy’s effect can be profound: in a clinical trial of 20 children, 16 had improvements in hearing about five months after treatment. Five of 12 followed for at least 11 months had their hearing essentially restored to normal.

“It’s miraculous,” Kerri, the mother of a clinical trial participant who requested her last name be withheld, told CNN. Her two-year-old son, Miles, had the gene therapy delivered to both ears last May. “You go from being told your child’s profoundly deaf and may only ever hear with technology to your child’s hearing right alongside his friends… this is just amazing.”

The gene therapy is made by biotechnology company Regeneron, which also made news with its planned price for the medicine. Often one-time gene therapies for rare conditions are priced by manufacturers at millions of dollars per patient in order to recoup their investment; Regeneron said Thursday that it will be free for patients in the US.

“We want to make an example of how science, and in this case biotech, can really deliver a gift to people—in this case, the gift of hearing,” Dr. George Yancopoulos, the co-founder and president of Regeneron, told CNN in an interview.

The medicine had been touted by FDA Commissioner Dr. Marty Makary as one the agency aimed to speed to market with a swift review under a new National Priority Voucher program. Regeneron also said it will attend an announcement at the White House Thursday focused on a Most Favored Nation drug pricing agreement; the deals aim to bring US drug prices more in line with the lower prices paid in peer nations in Europe and Asia.

The company said it plans to file for regulatory approval in countries other than the US, but didn’t say whether the therapy would also be made free to patients there.

The treatment, called Otarmeni, is administered using a surgical procedure similar to cochlear implantation, Regeneron said. It was shown to be safe in its clinical trial, with side effects related to those experienced from surgery. Regeneron noted costs of receiving the therapy may include out-of-pocket costs related to the surgical procedure, which isn’t performed by Regeneron.

This story is breaking and may be updated.

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Justice Department watchdog to investigate handling of Epstein files

Kraig Pakulski 0 10 Article rating: No rating

By Holmes Lybrand, CNN

(CNN) — The Justice Department’s internal watchdog is launching an investigation into the DOJ’s production of files and documents related to Jeffrey Epstein as controversy continues over the handling of the case of the convicted sex offender.

The Inspector General will focus on “the DOJ’s identification, collection, and production of responsive material,” it said in a statement Thursday, as well as “processes for redacting and withholding material” and how the Justice Department addressed issues following the release of Epstein documents.

The vast files collected throughout investigations related to Epstein were ordered to be released by Congress in a law that passed late last year. Some members of Congress have ridiculed the Justice Department for over-redactions and tracking their searches as they went through unredacted versions of the material.

Congress passed the Epstein Files Transparency Act in November after repeated failures from the Justice Department to deliver on past promises that they would be releasing information on Epstein – even material it did not have, like the long-fabled list of contacts and co-conspirators that now-former Attorney General Pam Bondi claimed was on her desk ready to be released early last year. No such list has been produced and the Justice Department has not charged anyone beyond Epstein and his co-conspirator Ghislaine Maxwell.

Bondi was fired by President Donald Trump early this year in part because of her continued bungling of the Epstein investigation.

The DOJ’s Inspector General previously found that, after an investigation, Epstein killed himself in a jail cell in 2019. Maxwell, his longtime business partner, is serving a 20-year sentence for her role in conspiring with Epstein to procure minors for him to sexually abuse.

This story is breaking and will be updated.

The-CNN-Wire
™ & © 2026 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.

The post Justice Department watchdog to investigate handling of Epstein files appeared first on News Channel 3-12.

¿Quién es Eva De Dominici, la actriz argentina que podría participar en la secuela de “Superman”?

Kraig Pakulski 0 12 Article rating: No rating

Por Gonzalo Jiménez, CNN en Español

Pese a que trabaja en Hollywood desde 2020, cuando participó en un episodio de la serie “Hawaii Five-0”, la carrera de la actriz argentina Eva De Dominici dio un salto al ser mencionada en The Hollywood Reporter el pasado 8 de abril como una de las cuatro actrices finalistas que audicionaron para un papel importante en “Man of Tomorrow”, la esperada secuela de “Superman”.

Según el reporte, las cuatro actrices que viajaron a Atlanta, Georgia, para hacer la prueba ante James Gunn, director de la cinta, fueron: Adria Arjona (“Andor”), Sydney Chandler (“Alien: Earth”), Grace Van Patten (“Tell Me Lies”) y De Dominici, de 31 años. DC y Gunn han negado que las audiciones fueran para el papel de Máxima, un personaje de las historietas de DC asociado con Superman.

Pocos días después, el sitio web The Wrap publicó que Arjona fue quien obtuvo el papel aunque no confirmó el personaje que interpretará en “Man of Tomorrow”.

Sin confirmaciones por parte de James Gunn, coCEO con Peter Safran de DC Studios, el fandom de los cómics se ha desatado en las redes sociales, con especulaciones sobre si De Dominici podría ser escogida como la nueva Mujer Maravilla en sustitución de Gal Gadot. Algunas cuentas en X recrearon la imagen de la actriz argentina con el traje de Wonder Woman.

El hermetismo de Gunn y las declaraciones de De Dominici el 18 de abril en el podcast “Agárrate, Carolina”, en la emisora La Once Diez, ha mantenido en ascuas al fandom. La actriz dijo: “No puedo hablar sobre DC, pero pronto van a empezar a anunciar a los actores que participarán”.

Así, de Dominici eligió una declaración ambigua en la que no reveló ni negó que pudiera ser escogida para un papel.

El periodista Jeff Sneider, que cubre de manera independiente la industria de cine en Hollywood, dijo en el podcast “The Hot Mic” del crítico John Rocha que, debido a que “Man of Tomorrow” inicia su rodaje este mes, una audición pocos días antes de la filmación sugiere que las cuatro actrices audicionaron para un papel que aparecerá por poco tiempo en la película, casi como un cameo, al estilo de la breve figuración de Supergirl (Milly Alcock) en “Superman” (2025). Sneider opinó que Arjona era la actriz de más peso en ese casting y que él era de la opinión de que ella había sido escogida para interpretar a la nueva Mujer Maravilla.

Esta teoría tiene sentido: Máxima no es un personaje tan conocido como el de la Mujer Maravilla. Creada por el guionista Roger Stern y el dibujante George Pérez en el ejemplar número 645 la historieta “Action Comics” en 1989, Máxima es una reina guerrera del planeta Almerac que desarrolla una obsesión por Superman, a quien considera el único hombre digno de ser su consorte. Sus inicios

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