FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fire Ahead of the FDA’s June target action date for Sarepta’s Duchenne muscular dystrophy gene therapy, ICER Chief Medical Officer David Rind blasted the regulator’s accelerated pathway in a JAMA viewpoint ... 05/3/2024 - 2:21 am | View Link
To save lives, the FDA must change how it evaluates rare disease treatments To get a green light from the FDA using the traditional approval process, new drugs must undergo two randomized, placebo-controlled clinical trials that confirm safety and clinical benefit — usually ... 04/30/2024 - 10:31 pm | View Link
US Supreme Court rejects Vanda Pharmaceuticals case over sleep-drug patents a circadian-rhythm drug used to treat rare sleep disorders. In the case, the Supreme Court declined a chance to consider for the first time since 2007 when a patent can be invalidated as "obvious ... 04/22/2024 - 4:52 am | View Link
UPDATE 1-U.S. Supreme Court rejects Vanda Pharmaceuticals case over sleep-drug patents a circadian-rhythm drug used to treat rare sleep disorders. In the case, the Supreme Court declined a chance to consider for the first time since 2007 when a patent can be invalidated as "obvious ... 04/21/2024 - 9:37 pm | View Link
US FDA approves Vanda's drug for treatment of bipolar disorder London: The U.S. FDA approved Vanda Pharmaceuticals' drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for ... 04/3/2024 - 1:30 am | View Link
Matt and Karen Smith visiting Glacier National Park. Courtesy of Matt and Karen Smith. A Gen X couple who has been to all 63 national parks says some are better than others in the summer. Matt and Karen Smith would avoid parks like Death Valley because of killer summer temperatures.
Downtown Los Angeles. ANDREY DENISYUK/Getty ImagesLos Angeles' downtown has become a hot spot for residential growth in the city. The neighborhood's office market, however, continues to languish. Downtown LA is expected to be a major draw for residential living over the next few decades. For generations, downtown Los Angeles was the region's nexus of commerce, as vast office spaces and old-line department stores made the neighborhood a business powerhouse.
ElevenLabs cofounders Mati Staniszewski (left) and Piotr Dabkowski (right) built a unicorn just a year after launching in beta. ElevenLabsAI voice tech company ElevenLabs is grappling with deepfakes. The technology, while innovative, has the potential for misuse, leading to concerns from lawmakers. ElevenLabs CEO said digitally watermarking synthetic voices is a solution.
Hard Rock Stadium in Miami, Florida. Clive Rose - Formula 1/Getty ImagesThe third-annual Miami Grand Prix is taking place this weekend. The Hard Rock Beach Club featured high-priced items, like a $280 Maine lobster roll, for the event. Formula 1 has a reputation for luxury and spectacle. Luxury was on full display during the Miami Grand Prix, especially at the Hard Rock Beach Club, where an order of wings cost nearly $200.
Former Colorado Rep. Ken Buck. Anna Moneymaker/Getty ImagesOnetime Rep. Ken Buck didn't have a very good impression of Capitol Hill upon his arrival in 2015. Buck told The New York Times that he wanted out of Congress "about three weeks" into the role. But the ex-congressman remarked that it took him a while to map out a plan to leave the House.
A crypto trader lost nearly $70 million in an "address poisoning" scam. Business InsiderA cryptocurrency trader lost nearly $70 million in an 'address poisoning' scam. Scammers made spoof accounts to trick the victim into sending funds to the fake address. Crypto-related scams are on the rise, costing investors almost $4 billion last year, the FBI says.