CAPE TOWN, South Africa (AP) — Clinical advocacy teams hold welcomed Johnson & Johnson’s resolution no longer to put in force its patent on a excessive tuberculosis treatment, allowing its production at mighty decrease costs, after South African authorities opened an investigation into the conglomerate.
The South African Competition Charge in a press free up on July 5 said it made up our minds no longer to prosecute a complaint against J&J concerning “allegations of abuse of dominance,” which was prompted after J&J and its subsidiary filed a secondary patent for bedaquiline final one year, faded to deal with drug-resistant TB.
Experts argued that the patent averted generic producers from making more affordable medicines, threatening the medication of tens of hundreds of folks in South Africa. TB killed bigger than 50,000 folks there in 2021, making it the nation’s leading location off of loss of life.
Authorities said J&J has agreed no longer to put in force its patent and to fall the trace charged to South Africa by about 40%.
“We hope this sends a substantial message to pharma that they can’t continue their anti-competitiveness monopoly and prioritize income over folks’s lives,” said Candice Sehoma, an advocacy adviser at Doctors Without Borders in South Africa.
Sehoma told The Connected Press on Tuesday that she hoped generic producers in South Africa might presumably presumably be ready to commence producing bedaquiline within the impending years, including that Indian factories already accomplish the drug.
Closing one year, activists in countries including India, Belarus and Ukraine protested against efforts by J&J to shield its patent on bedaquiline, however had little response. J&J utilized to hold its South Africa patent extended until 2027, enraging activists who accused it of profiteering.
In an habitual wander no longer easy the influence of astronomical prescribed medications, the South African authorities then began investigating the corporate’s pricing insurance policies. The nation had been paying about 5,400 rand ($282) per medication route, a ways bigger than uncomfortable countries that got the drug by a world effort known as the Close TB Partnership.
Fatima Hassan, the founder of the activist community Health Justice Initiative in South Africa, pointed out that patenting options for other key medicines for ailments including HIV, cancer and cystic fibrosis could additionally be investigated by regulatory companies for his or her pricing insurance policies.
“Going forward, pharmaceutical companies ought to be held in test and to yarn,” Hassan said in a press free up.
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US health regulators on Friday denied an utility for treating put up-demanding stress disorder (PTSD) with the drug MDMA, recurrently identified as ecstasy, pronouncing extra investigation wished to be carried out.
The firm that submitted the utility, Lykos Therapeutics, talked about in a statement that the Meals and Drug Administration (FDA) had requested an additional Section 3 clinical trial to stare MDMA’s “security and efficacy.”
A panel of consultants convened by the FDA to grab into narrative clinical recordsdata on MDMA had overwhelmingly voted in early June to boom there became insufficient proof to utter it became efficient.
Whereas unsurprising, the decision announced Friday represents a blow to advocates of the radical treatment.
“The FDA question of for some other stare is deeply disappointing, now not correct for all those who dedicated their lives to this pioneering effort, but mostly for the thousands and thousands of American citizens with PTSD… who be pleased now not viewed any contemporary treatment choices in over two an extended time, talked about Lykos CEO Amy Emerson.
PTSD is a debilitating mental health condition that develops after a person experiences or is threatened by demanding events akin to loss of life, fight or sexual assault.
It affects an estimated 5 percent of American citizens in any given 365 days.
Pharmaceutical treatment choices for PTSD are to this point little to 2 antidepressants that require three months of dosing to grab close, and response rates to the medicines had been found to be uneven.
MDMA—methylenedioxymethamphetamine—is a Time table 1 drug under the Managed Substances Act, and approving it for medical use would be pleased represented a prime shift.
California-based mostly mostly Lykos based mostly mostly its question of for regulatory approval on two clinical analysis, every of which enrolled around 100 of us, to grab into narrative MDMA old in conjunction with assorted psychological interventions akin to discuss therapy, towards a placebo with discuss therapy.
These two analysis, published within the accepted journal Nature Medication, indicated MDMA became indeed both safe and highly efficient at treating PTSD.
But nine out of 11 consultants on the FDA panel talked about on hand recordsdata became now not sufficient to utter the treatment became efficient, and 10 out of 11 talked about the advantages did now not outweigh the hazards.
In a briefing doc attach together earlier than the meeting, FDA team raised issues about Lykos’s clinical trial methodology and criticized the firm for now not gathering sufficient side close recordsdata.
The firm talked about this is in a position to presumably well “work diligently within the coming months to take care of FDA’s issues and to grab serve of company processes to resolve scientific disagreements.”
“We intend to work tirelessly and use all on hand regulatory pathways to search out an inexpensive and expeditious direction forward,” Emerson added.
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US health regulator rejects MDMA treatment for PTSD, for now (2024, August 10)
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SpaceX has done its investigation into what precipitated an engine failure all over a Falcon 9 begin on July 11th. The corporate has submitted a “mishap file” to the Federal Aviation Administration (FAA) and is intelligent to come the Falcon 9 rocket to flight as quickly as tomorrow to come.
The corporate’s investigation crew, working with the FAA, used to be in a collection up to discover the July 11th failure used to be precipitated by a liquid oxygen leak that developed all around the preliminary burn of the Falcon 9’s 2d stage engine. It says the leak originated from a crack in a pressure sensor sense line that’s portion of the rocket’s oxygen plot. A clamp that in general constrains the sense line had come loose, subjecting it to excessive engine vibrations that lastly precipitated it to fatigue and crack.
The leaking liquid oxygen on the Falcon 9 rocket’s upper stage precipitated “excessive cooling of engine parts, most importantly these linked to offer of ignition fluid to the engine,” in step with a assertion on SpaceX’s web situation. In converse of a 2d managed burn, the engine experienced what SpaceX describes as a “exhausting initiating,” unfavorable it and inflicting the upper stage to lose altitude defend a watch on.
The principle stage of the Falcon 9 performed as expected all around the July 11th begin and landed safely for reuse, however the 2d stage incident resulted in the Starlink satellites carried by the Falcon 9 being deployed at a lower orbit the set up “an significantly high-creep environment” precipitated all 20 of them to re-enter the Earth’s ambiance and confidently burn up.
To allow the Falcon 9 to come to flight as quickly as that you just might perhaps likely well have confidence, SpaceX engineers will simply rob away the sense line and sensor that failed on the 2d stage’s engine. “The sensor is no longer historical by the flight security plot and might perhaps likely well likely also be covered by alternate sensors already present on the engine.” The corporate has also inspected, cleaned, and modified just among the sense traces and clamps on its “energetic booster mercurial.” The modifications non-public already been tested by SpaceX at its facility in McGregor, Texas, beneath FAA oversight.
Now that the investigation is total, the Falcon 9 rocket is never any longer grounded and might perhaps likely well likely return to service. The company’s web situation says that SpaceX is focusing on July 27th at 12:21AM ET for the next Falcon 9 begin carrying 23 Starlink satellites from NASA’s Kennedy Self-discipline Heart, with extra begin window alternatives readily accessible later in the day, and on July 28th.
TOPEKA, Kan. (AP) — Kansas could soon offer up to $5 million in grants for schools to outfit surveillance cameras with artificial intelligence systems that can spot people carrying guns. But the governor needs to approve the expenditures and the schools must meet some very specific criteria.
The AI software must be patented, “designated as qualified anti-terrorism technology,” in compliance with certain security industry standards, already in use in at least 30 states and capable of detecting “three broad firearm classifications with a minimum of 300 subclassifications” and “at least 2,000 permutations,” among other things.
Only one company currently meets all those criteria: the same organization that touted them to Kansas lawmakers crafting the state budget. That company, ZeroEyes, is a rapidly growing firm founded by military veterans after the fatal shooting at Marjory Stoneman Douglas High School in Florida.
The legislation pending before Kansas Gov. Laura Kelly highlights two things. After numerous high-profile shootings, school security has become a multibillion-dollar industry. And in state capitols, some companies are successfully persuading policymakers to write their particular corporate solutions into state law.
ZeroEyes also appears to be the only firm qualified for state firearms detection programs under laws enacted last year in Michigan and Utah, bills passed earlier this year in Florida and Iowa and legislation proposed in Colorado, Louisiana and Wisconsin.
On Friday, Missouri became the latest state to pass legislation geared toward ZeroEyes, offering $2.5 million in matching grants for schools to buy firearms detection software designated as “qualified anti-terrorism technology.”
“We’re not paying legislators to write us into their bills,” ZeroEyes co-founder and Chief Revenue Officer Sam Alaimo said. But “if they’re doing that, it means I think they’re doing their homework, and they’re making sure they’re getting a vetted technology.”
Rob Huberty, Chief Operating Officer and Co-Founder of ZeroEyes, talks about the use of artificial intelligence with surveillance cameras to identify visible guns at the company’s greenscreen lab, Friday, May 10, 2024, in Conshohocken, Pa. (AP Photo/Matt Slocum)
ZeroEyes uses artificial intelligence with surveillance cameras to identify visible guns, then flashes an alert to an operations center staffed around the clock by former law enforcement officers and military veterans. If verified as a legitimate threat by ZeroEyes personnel, an alert is sent to school officials and local authorities.
The goal is to “get that gun before that trigger’s squeezed, or before that gun gets to the door,” Alaimo said.
Few question the technology. But some do question the legislative tactics.
The super-specific Kansas bill — particularly the requirement that a company have its product in at least 30 states — is “probably the most egregious thing that I have ever read” in legislation, said Jason Stoddard, director of school safety and security for Charles County Public Schools in Maryland.
ZeroEyes analysts monitor alerts at the company’s operations center, Friday, May 10, 2024, in Conshohocken, Pa. (AP Photo/Matt Slocum)
Stoddard is chairperson of the newly launched National Council of School Safety Directors, which formed to set standards for school safety officials and push back against vendors who are increasingly pitching particular products to lawmakers.
When states allot millions of dollars for certain products, it often leaves less money for other important school safety efforts, such as electronic door locks, shatter-resistant windows, communication systems and security staff, he said.
“The artificial-intelligence-driven weapons detection is absolutely wonderful,” Stoddard said. “But it’s probably not the priority that 95% of the schools in the United States need right now.”
The technology also can be costly, which is why some states are establishing grant programs. In Florida, legislation to implement ZeroEyes technology in schools in just two counties cost a total of about $929,000.
ZeroEyes is not the only company using surveillance systems with artificial intelligence to spot guns. One competitor, Omnilert, pivoted from emergency alert systems to firearms detection several years ago and also offers around-the-clock monitoring centers to quickly review AI-detected guns and pass alerts onto local officials.
ZeroEyes analyst Mario Hernandez demonstrates the use of artificial intelligence with surveillance cameras to identify visible guns at the company’s operations center, Friday, May 10, 2024, in Conshohocken, Pa. (AP Photo/Matt Slocum)
But Omnilert does not yet have a patent for its technology. And it has not yet been designated by the U.S. Department of Homeland Security as an anti-terrorism technology under a 2002 federal law providing liability protections for companies. It has applied for both.
Though Omnilert is in hundreds of schools, its products aren’t in 30 states, said Mark Franken, Omnilert’s vice president of marketing. But he said that shouldn’t disqualify his company from state grants.
Franken has contacted the Kansas governor’s office in hopes she will line-item veto the specific criteria, which he said “create a kind of anti-competitive environment.”
In Iowa, legislation requiring schools to install firearms detection software was amended to give companies providing the technology until July 1, 2025, to receive federal designation as an anti-terrorism technology. But Democratic state Rep. Ross Wilburn said that designation was originally intended as an incentive for companies to develop technology.
“It was not put in place to provide, promote any type of advantage to one particular company or another,” Wilburn said during House debate.
Kansas House K-12 Education Budget Committee Chair Kristey Williams, right, R-Augusta, confers with House Majority Leader Chris Croft, left, R-Overland Park, during a break in a daylong session at the Statehouse in Topeka, Kan., Thursday, April 4, 2024 (AP Photo/John Hanna)
In Kansas, ZeroEyes’ chief strategy officer presented an overview of its technology in February to the House K-12 Education Budget Committee. It included a live demonstration of its AI gun detection and numerous actual surveillance photos spotting guns at schools, parking lots and transit stations. The presentation also noted authorities arrested about a dozen people last year directly as a result of ZeroEyes alerts.
Kansas state Rep. Adam Thomas, a Republican, initially proposed to specifically name ZeroEyes in the funding legislation. The final version removed the company’s name but kept the criteria that essentially limits it to ZeroEyes.
House K-12 Budget Committee Chair Kristey Williams, a Republican, vigorously defended that provision. She argued during a negotiating meeting with senators that because of student safety, the state couldn’t afford the delays of a standard bidding process. She also touted the company’s technology as unique.
”We do not feel that there was another alternative,” Williams said last month.
The $5 million appropriation won’t cover every school, but Thomas said the amount could later increase once people see how well ZeroEyes technology works.
“I’m hopeful that it does exactly what we saw it do and prevents gun violence in the schools,” Thomas told The Associated Press, “and we can eventually get it in every school.”
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Lieb reported from Jefferson City, Missouri. Associated Press writer Hannah Fingerhut contributed from Des Moines, Iowa.
