FDA Rejects MDMA-Assisted Therapy For PTSD

The FDA has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA as a treatment for post-traumatic stress disorder (PTSD), according to drugmaker Lykos Therapeutics. NBC News reports: There had been intense political pressure on the FDA to approve the drug. Friday’s decision was the first time the agency had considered a Schedule 1 psychedelic for medical use. If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. The agency’s decision came after an independent advisory committee in June declined to recommend approval of the drug, saying there was not enough evidence that the therapy was safe and effective.

The committee cited a myriad of concerns, including poorly designed studies, allegations of sexual misconduct during a midstage clinical trial and the potential for serious health risks after taking the drug, including heart problems and abuse. A review by FDA scientists, published ahead of the June meeting, also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo. Despite the rejection, experts say they expect that psychedelic therapies are still on their way to FDA approval. There are around four dozen MDMA trials in various stages of clinical development, according to ClinicalTrials.gov. “I think it will be a temporary setback,” said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. “The advisory committee and FDA gave very clear indications of what they’re looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved.”

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Japan Issues First Ever ‘Megaquake’ Warning

After a 7.1 tremor struck southwestern Japan on Thursday, the country’s meteorological agency issued its first-ever alert for a possible “megaquake.” It marks the first time the warning has been issued under new rules drawn up after a 2011 earthquake, tsunami and nuclear disaster killed almost 20,000 people. Phys.org reports: The JMA’s “megaquake advisory” warns that “if a major earthquake were to occur in the future, strong shaking and large tsunamis would be generated.” “The likelihood of a new major earthquake is higher than normal, but this is not an indication that a major earthquake will definitely occur during a specific period of time,” it added. The advisory concerns the Nankai Trough “subduction zone” between two tectonic plates in the Pacific Ocean, where massive earthquakes have hit in the past. […]

Japan’s government has previously said the next magnitude 8-9 megaquake along the Nankai Trough has a roughly 70 percent probability of striking within the next 30 years. In the worst-case scenario 300,000 lives could be lost, experts estimate, with some engineers saying the damage could reach $13 trillion with infrastructure wiped out. “The history of great earthquakes at Nankai is convincingly scary,” geologists Kyle Bradley and Judith A Hubbard wrote in their Earthquake Insights newsletter. And “while earthquake prediction is impossible, the occurrence of one earthquake usually does raise the likelihood of another”, they explained. “A future great Nankai earthquake is surely the most long-anticipated earthquake in history — it is the original definition of the ‘Big One’.”

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Cloud Growth Puts Hyperscalers On Track To 60% of Data Capacity By 2029

Dan Robinson writes via The Register: Hyperscalers are forecast to account for more than 60 percent of datacenter space by 2029, a stark reversal on just seven years ago when the majority of capacity was made up of on-premises facilities. This trend is the result of demand for cloud services and consumer-oriented digital services such as social networking, e-commerce and online gaming pushing growth in hyperscale bit barns, those operated by megacorps including Amazon, Microsoft and Meta. The figures were published by Synergy Research Group, which says they are drawn from several detailed quarterly tracking research services to build an analysis of datacenter volume and trends.

As of last year’s data, those hyperscale companies accounted for 41 percent of the entire global data dormitory capacity, but their share is growing fast. Just over half of the hyperscaler capacity is comprised of own-build facilities, with the rest made up of leased server farms, operated by providers such as Digital Realty or Equinix. On-premises datacenters run by enterprises themselves now account for 37 percent of the total, a drop from when they made up 60 percent a few years ago. The remainder (22 percent) is accounted for by non-hyperscale colocation datacenters.

What the figures appear to show is that hyperscale volume is growing faster than colocation or on-prem capacity — by an average of 22 percent each year. Hence Synergy believes that while colocation’s share of the total will slowly decrease over time, actual colo capacity will continue to rise steadily. Likewise, the proportion of overall bit barn space represented by on-premise facilities is forecast by Synergy to decline by almost three percentage points each year, although the analyst thinks the actual total capacity represented by on-premises datacenters is set to remain relatively stable. It’s a case of on-prem essentially standing still in an expanding market.

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FTX Ordered To Pay $12.7 Billion To Customers, US CFTC Says

FTX has been ordered to pay $12.7 billion in relief to its customers, according to the Commodity Futures Trading Commission (CFTC). In a statement, CFTC Chairman Rostin Behnam said the crypto exchange drew customers in with “an illusion that it was a safe and secure place to access crypto markets,” then misappropriated their customer deposits to make its own risky investments. Reuters reports: The repayment order implements a settlement between the CFTC and the bankrupt crypto exchange, which has committed to a bankruptcy liquidation that will repay customers whose deposits were locked during its late 2022 collapse. FTX has said that its customers will receive 100% recovery on their claims against the company, based on the value of their accounts at the time it filed for bankruptcy. The CFTC agreement resolves a potential roadblock to that repayment, ensuring that the government’s lawsuit against FTX will not reduce the funds available to its customers. The CFTC agreed not to collect any payment from FTX until all its customers are repaid, with interest.

The CFTC settlement requires FTX to pay $8.7 billion in restitution and $4 billion in disgorgement, which will be used to further compensate victims for losses suffered during the exchange’s collapse. […] FTX is currently soliciting votes on its bankruptcy proposal but faces opposition from some customers who feel short-changed by the decision to repay them based on much-lower cryptocurrency prices from November 2022. Votes are due on Aug. 16, and FTX intends to seek final approval of its wind-down plan on Oct. 7.

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