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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