FDA Approves Most Expensive Drug Ever, a $3.5 Million-per-Dose Gene Therapy For Hemophilia B

U.S. health regulators this week approved the first gene therapy for hemophilia, a $3.5 million one-time treatment for the blood-clotting disorder. From a report: The Food and Drug Administration cleared Hemgenix, an IV treatment for adults with hemophilia B, the less common form of the genetic disorder which primarily affects men. Currently, patients receive frequent, expensive IVs of a protein that helps blood clot and prevent bleeding. Drugmaker CSL Behring, based in Pennsylvania, announced the $3.5 million price tag shortly after the FDA approval, saying its drug would ultimately reduce health care costs because patients would have fewer bleeding incidents and need fewer clotting treatments.

According to a study cited by the National Library of Medicine, the price makes Hemgenix the most expensive medicine in the world, easily topping Novartis’ Zolgensma gene therapy for spinal muscular atrophy (SMA), which costs right around $2 million per dose and is also a single-dose medicine. Like most medicines in the U.S., most of the cost of the new treatment will be paid by insurers, not patients, including private plans and government programs. After decades of research, gene therapies have begun reshaping the treatment of cancers and rare inheritable diseases with medicines that can modify or correct mutations embedded in people’s genetic code. Hemgenix is the first such treatment for hemophilia and several other drugmakers are working on gene therapies for the more common form of the disorder, hemophilia A.

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Intel Officially Introduces Pay-As-You-Go Chip Licensing

Intel has officially revealed its Intel On Demand program that will activate select accelerators and features of the company’s upcoming Xeon Scalable Sapphire Rapids processor. The new pay-as-you-go program will allow Intel to reduce the number of SKUs it ships while still capitalizing on the technologies it has to offer. From a report: Furthermore, its clients will be able to upgrade their machines without replacing actual hardware or offering additional services to their clients. Intel’s upcoming Intel’s 4th Generation Xeon Scalable Sapphire Rapids processors are equipped with various special-purpose accelerators and security technologies that all customers do not need at all times. To offer such end-users additional flexibility regarding investments, Intel will deliver them to buy its CPUs with those capabilities disabled but turn them on if they are needed at some point. The Software Defined Silicon (SDSi) technology will also allow Intel to sell fewer CPU models and then enable its clients or partners to activate certain features if needed (to use them on-prem or offer them as a service). The list of technologies that Intel wants to make available on demand includes Software Guard Extensions, Dynamic Load Balancer (DLB), Intel Data Streaming Accelerator (DSA), Intel In-Memory Analytics Accelerator (IAA), Intel In-Memory Analytics Accelerator, and Intel QuickAssist Technology (QAT) to accelerate specific workloads.

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Google’s Secret New Project Teaches AI To Write and Fix Code

Google is working on a secretive project that uses machine learning to train code to write, fix, and update itself. From a report: This project is part of a broader push by Google into so-called generative artificial intelligence, which uses algorithms to create images, videos, code, and more. It could have profound implications for the company’s future and developers who write code. The project, which began life inside Alphabet’s X research unit and was codenamed Pitchfork, moved into Google’s Labs group this summer, according to people familiar with the matter. By moving into Google, it signaled its increased importance to leaders. Google Labs pursues long-term bets, including projects in virtual and augmented reality.

Pitchfork is now part of a new group at Labs named the AI Developer Assistance team run by Olivia Hatalsky, a long-term X employee who worked on Google Glass and several other moonshot projects. Hatalsky, who ran Pitchfork at X, moved to Labs when it migrated this past summer. Pitchfork was built for “teaching code to write and rewrite itself,” according to internal materials seen by Insider. The tool is designed to learn programming styles and write new code based on those learnings, according to people familiar with it and patents reviewed by Insider. “The team is working closely with the Research team,” a Google representative said. “They’re working together to explore different use cases to help developers.”

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US Navy Forced To Pay Software Company For Piracy

The U.S. Navy was found guilty of piracy and is ordered to pay a software company $154,400 for a lawsuit filed back in 2016. Gizmodo reports: The company, Bitmanagement Software GmbH, filed a complaint against the Navy, accusing the military branch of copyright infringement. GmbH claimed they had issued 38 copies of their 3D virtual reality software, BS Contact Geo, but while they were still in negotiations for additional licenses, the Navy installed the software onto at least 558,466 machines between 2013 and 2015. In the court filing (PDF), GmbH claimed, “Without Bitmanagement’s advance knowledge or consent, the Navy installed BS Contact Go onto hundreds of thousands of computers. Bitmanagement did not license or otherwise authorize these uses of its software, and the Navy has never compensated Bitmanagement for these uses of Bitmanagement’s software.”

The company sued the Navy for nearly $600 million for “willful copyright infringement” of the software which, according to the vendor’s website, is a 3D viewer that “enables you to visualize and interact with state of the art 2D/3D content,” and is based on digital data captured from “various sources (land surveys, CAD, satellite imagery, airborne laser scanning, etc).” The court filings stated that after GmbH filed the lawsuit in July 2016, the Navy uninstalled the BS Contact Geo software from all of its computers and “subsequently reinstalled the software on 34 seats, for inventory purposes.” GmbH wrote in the court filing, “The government knew or should have known that it was required to obtain a license for copying Bitmanagement software onto each of the devices that had Bitmanagement software installed. The government nonetheless failed to obtain such licenses.”

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Frederick P. Brooks Jr., Computer Design Innovator, Dies at 91

Frederick P. Brooks Jr., whose innovative work in computer design and software engineering helped shape the field of computer science, died on Thursday at his home in Chapel Hill, N.C. He was 91. His death was confirmed by his son, Roger, who said Dr. Brooks had been in declining health since having a stroke two years ago. The New York Times reports: Dr. Brooks had a wide-ranging career that included creating the computer science department at the University of North Carolina and leading influential research in computer graphics and virtual reality. But he is best known for being one of the technical leaders of IBM’s 360 computer project in the 1960s. At a time when smaller rivals like Burroughs, Univac and NCR were making inroads, it was a hugely ambitious undertaking. Fortune magazine, in an article with the headline “IBM’s $5,000,000,000 Gamble,” described it as a “bet the company” venture.

Until the 360, each model of computer had its own bespoke hardware design. That required engineers to overhaul their software programs to run on every new machine that was introduced. But IBM promised to eliminate that costly, repetitive labor with an approach championed by Dr. Brooks, a young engineering star at the company, and a few colleagues. In April 1964, IBM announced the 360 as a family of six compatible computers. Programs written for one 360 model could run on the others, without the need to rewrite software, as customers moved from smaller to larger computers. The shared design across several machines was described in a paper, written by Dr. Brooks and his colleagues Gene Amdahl and Gerrit Blaauw, titled “Architecture of the IBM System/360.”
“That was a breakthrough in computer architecture that Fred Brooks led,” Richard Sites, a computer designer who studied under Dr. Brooks, said in an interview.

But there was a problem. The software needed to deliver on the IBM promise of compatibility across machines and the capability to run multiple programs at once was not ready, as it proved to be a far more daunting challenge than anticipated. Operating system software is often described as the command and control system of a computer. The OS/360 was a forerunner of Microsoft’s Windows, Apple’s iOS and Google’s Android. At the time IBM made the 360 announcement, Dr. Brooks was just 33 and headed for academia. He had agreed to return to North Carolina, where he grew up, and start a computer science department at Chapel Hill. But Thomas Watson Jr., the president of IBM, asked him to stay on for another year to tackle the company’s software troubles. Dr. Brooks agreed, and eventually the OS/360 problems were sorted out. The 360 project turned out to be an enormous success, cementing the company’s dominance of the computer market into the 1980s. “Fred Brooks was a brilliant scientist who changed computing,” Arvind Krishna, IBM’s chief executive and himself a computer scientist, said in a statement. “We are indebted to him for his pioneering contributions to the industry.”

Dr. Brooks published a book in 1975 titled, “The Mythical Man-Month: Essays on Software Engineering.” It was “a quirky classic, selling briskly year after year and routinely cited as gospel by computer scientists,” reports the Times.

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Amazon To Spend $1 Billion a Year On Theatrical Film Releases

Zoom Shares Plunge 90% From Peak As Pandemic Boom Fades

Shares of Zoom have tumbled about 90% from their pandemic peak in October 2020 as the former investor darling struggles to adjust to a post-COVID world. Reuters reports: The stock was down nearly 10% on Tuesday after the company cut its annual sales forecast and posted its slowest quarterly growth, prompting at least six brokerages to cut their price targets. The company, which became a household name during lockdowns due to the popularity of its video-conferencing tools, is trying to reinvent itself by focusing on businesses, with products such as cloud-calling service Zoom Phone and conference-hosting offering Zoom Rooms. Analysts, however, say any turnaround in the business is still a few quarters away as growth in its mainstay online unit slows and competition from Microsoft’s Teams and Cisco’s Webex and Salesforce’s Slack gets intense.

“Zoom has a fundamental flaw — it has needed to spend heavily to keep hold of market share. Spending to cling onto, rather than grow, market share is never a good place to be and was a sign of trouble ahead,” Hargreaves Lansdown equity analyst Sophie Lund-Yates said. The company’s operating expenses surged 56% in the third quarter as it spent more on product development and marketing. Its adjusted operating margin shrank to 34.6% from 39.1% a year earlier.

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Amazon Launches Second Cloud Region In India, Pledges $4.4 Billion Investment

Amazon has set up its second AWS region in India and says the cloud unit will invest more than $4.4 billion in the South Asian market by 2030, part of the company’s attempts to widen its growing cloud tentacles across the globe. TechCrunch reports: The retailer said Tuesday that it has launched an AWS infrastructure region in the city of Hyderabad, its second cloud region in the country. An additional AWS datacenter cluster will allow the firm to offer “greater choice” in the country and support over 48,000 full-time jobs annually, Amazon said. AWS, which leads the cloud market in India, has amassed a number of major clients in the country including Axis Bank, HDFC Bank, Niti Aayog, PhysicsWallah and Acko. “As a part of Prime Minister Narendra Modi’s $1 Trillion Digital Economy vision, the ‘India cloud’ is set for big expansion and innovation. Data centers are an important element of the digital ecosystem. The investments by AWS in expanding their data centers in India is a welcome development and would certainly help catalyze India’s digital economy,” said Rajeev Chandrashekhar, Union Minister of State for Electronics and Information Technology and for Skill Development and Entrepreneurship, in a statement.

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iFixit Put Up a Right To Repair Billboard Along New York Governor’s Drive To Work

Right to Repair website iFixit put up a billboard in Albany, New York, calling for Gov. Kathy Hochul to sign the landmark Right to Repair law, which was passed overwhelmingly nearly six months ago by the state legislature. PIRG reports: Supported by Repair.org, U.S. PIRG and NYPIRG, Consumer Reports, Environment New York, the Story of Stuff Project, Sierra Club Atlantic Chapter, NRDC, Environmental Action and EFF, calls for the governor to sign the bill have increased The legislation must advance to the governor by the end of December and be signed by January 10, 2023.

The Albany Times Union editorialized twice for the governor to sign the bill, recently noting that the bill has come under intense opposition from manufacturers: “Meanwhile, lobbyists, big corporations and a few trade organizations are pressing for a veto … Ms. Hochul must sign the bill, and then lawmakers should get to work passing an expanded version that includes all the products that were needlessly stripped from the original. Big corporations and the lobbyists they hire won’t be happy, but that shouldn’t matter a bit.”

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Did Sam Bankman-Fried’s Millions Buy the Media’s Loyalty?

As the FTX fallout continues to unfold, Reason reports:

The mainstream coverage of SBF and FTX is more than a little blase… SBF was heavily involved in Democratic Party politics: In the 2022 election cycle, he was the second most prolific funder of Democratic candidates. But he wasn’t just a funder of electoral efforts. He funded both progressive and mainstream media organizations…
But SBF’s own attitude toward his funding of these causes seems to be that it’s all for show. When asked if ethics is “mostly a front”, SBF replied “yeah, that’s not all of it but it’s a lot.”
If SBF considered his generous donations to be a “front” for something else, one wonders what about the else. Is it perhaps the case that SBF thought he was actually buying goodwill and favorable coverage? He was, as it happens, the beneficiary of countless gushing magazine profiles and was frequently hailed as the “white knight” of crypto.
Indeed, SBF is still benefitting from some kinder-than-expected coverage from the mainstream media, even in the wake of the revelations about his fraudulent activities” and even from outlets that did not receive his largesse.
Read Reason’s full article here.

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