Ironwood's Constipation Drug Shows Efficacy In Pediatric Patients

 

• Ironwood Pharmaceuticals Inc (NASDAQ: IRWD) announced topline data from a Phase 3 trial evaluating Linzess (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation.

• The trial met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved the frequency of spontaneous bowel movements (SBM) and stool consistency.

• Linaclotide was generally well-tolerated, and the safety profile is consistent with previous studies.

• In this study, 330 patients were randomized in a 1:1 ratio between linaclotide or placebo.

• There are currently no FDA-approved pediatric therapies for Functional Constipation, affecting an estimated 4 to 6 million children ages 6 to 17 in the U.S.

• The most frequently reported treatment-emergent adverse event was diarrhea, which occurred in 4.3% of linaclotide-treated participants versus 1.8% in the placebo group.

• Linzess is developed and marketed by Ironwood and AbbVie Inc (NYSE: ABBV) in the U.S. and is indicated for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. It is not approved for use in patients less than 18 years of age.

https://finance.yahoo.com/news/ironwoods-constipation-drug-shows-efficacy-132638880.html

Bausch + Lomb, Novaliq Eye-Drop Treatment's New Drug Application Accepted by FDA

 Bausch + Lomb Corp. said Tuesday that the U.S. Food and Drug Administration has accepted its new drug application for an eye drop to treat the symptoms of dry eye disease.

The eye-health company said the filing for investigational treatment NOV03 is in conjunction with biopharmaceutical company Novaliq GmbH.

The clinical development program for NOV03 have shown statistically significant improvement in two Phase 3 studies, the company said.

"The approval would also mark a significant milestone for Bausch + Lomb, as the company's first FDA approval for a prescription medicine since becoming a publicly traded company earlier this year," Chief Executive Joseph C. Papa said.

https://www.marketscreener.com/quote/stock/BAUSCH-LOMB-CORPORATION-137315071/news/Bausch-Lomb-Novaliq-Eye-Drop-Treatment-s-New-Drug-Application-Accepted-by-FDA-41703983/

Spero Up on FDA's Feedback of Tebipenem HBr Program

 Shares of Spero Therapeutics Inc. climbed 38% to $1.01 Tuesday following feedback from the Food and Drug Administration on its tebipenem HBr program.

The FDA indicated that positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection, with supportive evidence of efficacy, could support approval of tebipenem HBr, the company said.

Spero and the FDA also have agreed on the regulatory path forward for the therapy, the company said. The groups are aligned on key components of the proposed Phase 3 trial design, which may be the subject of a special protocol assessment request, Spero said.

"With this clarity, we are better positioned to advance the program as we work to establish and nurture external partnerships for further development," Chief Executive Ankit Mahadevia said.

https://www.marketscreener.com/quote/stock/SPERO-THERAPEUTICS-INC-38533873/news/Spero-Therapeutics-Shares-Up-38-On-FDA-s-Feedback-of-Tebipenem-HBr-Program-41706072/

French court to rule on plan to block porn sites over access for minors

 

A Paris court is set to rule next month on whether a French regulator has the right to block access to international porn sites in France unless those sites can guarantee they can prevent minors under 18 from accessing them.

Following a complaint by children's rights associations, French audiovisual and digital regulator Arcom in December 2021 gave notice to five porn sites including Pornhub, requiring them to prove they were blocking access to minors in line with July 2020 French legislation.

An Arcom official said that since then the regulator had seen no indication the sites were putting in place systems that could really block access for minors, it decided to take legal action.

The four other sites being challenged by the regulator are Tukif, Xhamster, Xnxx and Xvideos.

The regulator said it wanted the court to order French internet service providers such as Orange, Free and SFR to block access to these porn sites on French territory until they have a solid system for blocking access to minors.

At a hearing on Tuesday, lawyers for the porn sites argued the court was not authorised to rule on the case as the law was not in line with the constitution. The court will now rule on Oct. 4 whether it can decide on the issue or whether the case needs to go to the appeals court, an Arcom official said.

Currently, porn sites in France only have to display a disclaimer button on which users can click to say that they are over 18, but there is no verification of their actual age.

An Arcom official said the sites - which are all free - would have to propose a free and reliable blocking system.

A lawyer for PornHub publisher MG Freesites did not immediately return calls for comment. She was quoted on French radio franceinfo as saying that verifying an internet user's age is technically and legally impossible.

In recent months, Arcom has also served notice to several other porn sites, including YouPorn, one of the world's top porn sites, the Arcom official said.

French children's rights associations have started several legal cases to block access to online pornography for minors, arguing that current age verification standards make it too easy for children to access the websites.

https://www.marketscreener.com/news/latest/French-court-to-rule-on-plan-to-block-porn-sites-over-access-for-minors--41706557/

HSBC not liable for al-Qaeda suicide attack at CIA base -US appeals court

 

A divided U.S. appeals court on Tuesday said HSBC Holdings Plc was not liable to the families of two American contractors killed in an al-Qaeda suicide bombing of a CIA base in Afghanistan, after the bank allegedly evaded U.S. sanctions targeting sponsors of terrorism.

Dane Paresi and Jeremy Wise were among nine killed when Humam Khalil al-Balawi, a doctor, blew himself up by detonating hidden explosives at Camp Chapman on Dec. 30, 2009.

Their families accused HSBC of violating federal anti-terrorism laws through its dealings with Iran's state-controlled Bank Melli and Bank Saderat and Saudi Arabia's Al Rajhi Bank, each with alleged financial ties to al-Qaeda or other U.S.-designated terrorist groups.

But in a 2-1 decision, the D.C. Circuit Court of Appeals said the families did not plausibly allege that HSBC aided and abetted al-Qaeda terrorism, or was "generally aware" it played a role, through its years of dealings with intermediary banks.

"A lengthy financial relationship does not terrorism assistance make," Circuit Judge Neomi Rao wrote for the majority.

Rao also upheld the dismissal of claims against foreign-based HSBC entities, including the parent, saying the court lacked jurisdiction.

The decision followed last month's U.S. Federal Reserve termination of a decade-old HSBC enforcement order.

That order was imposed when the bank paid a $1.92 billion fine to resolve a related U.S. Department of Justice criminal probe into alleged violations of sanctions and anti-money laundering rules.

Circuit Judge Robert Wilkins dissented from Tuesday's decision, saying he would have allowed the aiding-and-abetting claim and found jurisdiction over the foreign defendants.

Randy Singer, a lawyer for the plaintiffs, said they plan to ask the full D.C. Circuit to reconsider the decision.

"As [Judge Wilkins] noted, dismissing this case frustrates the intent of Congress in passing the Anti-Terrorism Act and deprives these plaintiffs of their rightful opportunity to prove their well-pleaded allegations in court," he said.

HSBC and its lawyers did not immediately respond to requests for comment.

The case is Bernhardt et al v Islamic Republic of Iran et al, D.C. Circuit Court of Appeals, No. 21-7018.

https://www.marketscreener.com/news/latest/HSBC-not-liable-for-al-Qaeda-suicide-attack-at-CIA-base-US-appeals-court--41706645/

Juul Labs reaches $438.5 million settlement over marketing and sales practices

 

Juul Labs has reached a $438.5 million settlement to resolve a two-year probe by 34 U.S. states and territories concerning the e-cigarette maker's marketing and sales practices.

Connecticut Attorney General William Tong, whose state led the probe, said the accord also requires Juul to make several changes to its practices, including refraining from youth marketing, using cartoons and providing free samples.

https://www.marketscreener.com/news/latest/Juul-Labs-reaches-438-5-million-settlement-over-marketing-and-sales-practices--41706671/

Banned U.S. AI chips in high demand at Chinese state institutes

 

High-profile universities and state-run research institutes in China have been relying on a U.S. computing chip to power their artificial intelligence (AI) technology but whose export to the country Washington has now restricted, a Reuters review showed.

U.S. chip designer Nvidia Corp last week said U.S. government officials have ordered it to stop exporting its A100 and H100 chips to China. Local peer Advanced Micro Devices Inc (AMD) also said new licence requirements now prevent export to China of its advanced AI chip MI250.

The development signalled a major escalation of a U.S. campaign to stymie China's technological capability as tension bubbles over the fate of Taiwan, where chips for Nvidia and almost every other major chip firm are manufactured.

China views Taiwan as a rogue province and has not ruled out force to bring the democratically governed island under its control. Responding to the restrictions, China branded them a futile attempt to impose a technology blockade on a rival.

A Reuters review of more than a dozen publicly available government tenders over the past two years indicated that among some of China's most strategically important research institutes, there is high demand - and need - for Nvidia's signature A100 chips.

Tsinghua University, China's highest-ranked higher education institution globally, spent over $400,000 last October on two Nvidia AI supercomputers, each powered by four A100 chips, one of the tenders showed.

In the same month, the Institute of Computing Technology, part of top research group, the Chinese Academy of Sciences (CAS), spent around $250,000 on A100 chips.

The school of artificial intelligence at a CAS university in July this year also spent about $200,000 on high-tech equipment including a server partly powered by A100 chips.

In November, the cybersecurity college of Guangdong-based Jinan University spent over $93,000 on an Nvidia AI supercomputer, while its school of intelligent systems science and engineering spent almost $100,000 on eight A100 chips just last month.

Less well-known institutes and universities supported by municipal and provincial governments, such as in Shandong, Henan and Chongqing, also bought A100 chips, the tenders showed.

None of the research departments responded to requests for comment on the effect on their projects of the A100 export curb.

Nvidia did not respond to a request for comment. Last Wednesday, it said it had booked $400 million in Chinese sales of the affected chips this quarter which could be lost if its customers decide not to buy alternative Nvidia products. It also said it planned to apply for exemptions to the new rules.

REPLACEMENTS

The lack of chips from the likes of Nvidia and AMD is likely to hamper efforts at Chinese organisations to cost-effectively carry out the kind of advanced computing used for tasks such as image and speech recognition.

Image recognition and natural language processing are common in consumer applications such as smartphones that can answer queries and tag photos. They also have military uses such as scouring satellite imagery for weapons or bases and filtering digital communications for intelligence-gathering purposes.

Experts said there are few Chinese chipmakers that could readily replace such advanced Nvidia and AMD chips, and buyers could instead use multiple lower-end chips to replicate the processing power.

Reuters could not locate any Chinese government tenders mentioning the other two restricted chips - Nvidia's H100 and AMD's MI250.

But some of the tenders showed, for instance, chip purchases from U.S. technology firm Intel Corp and proposals for purchasing less-sophisticated Nvidia products, underscoring China's reliance on an array of U.S. chip technology.

One tender in May showed the Chinese Academy of Surveying and Mapping, a research institute of the Ministry of Natural Resources, considering an Nvidia AI supercomputer to improve its ability to create three-dimensional images from geographic data.

"The proposed NVIDIA DGX A100 server will be equipped with 8 A100 chips with 40GB memory, which will greatly improve the data-carrying capacity and computing speed, shorten the scientific research process, and get scientific research results faster and better," the tender read.

The National University of Defense and Technology (NUDT), which describes itself as a "military university" and "under the direct leadership of the Central Military Commission", China's top military body, is also among the buyers of A100 chips.

The NUDT, home of Tianhe-2, one of the world's most powerful supercomputers, has been on a U.S. blacklist since 2015 due to national security concerns, eliminating the university's access to the Intel processors it uses in its supercomputers.

One May tender showed the institute planned to buy 24 Nvidia graphics processing units with AI applications. The tender was published again last month, indicating NUDT had not yet found the right deal or supplier.

https://www.marketscreener.com/quote/stock/ADVANCED-MICRO-DEVICES-I-19475876/news/Analysis-Banned-U-S-AI-chips-in-high-demand-at-Chinese-state-institutes-41700688/