Visiting Vietnam, Putin seeks new 'security architecture' for Asia

 Russian President Vladimir Putin said he wanted to build a "reliable security architecture" in the Asia-Pacific region during a state visit to Vietnam on Thursday, part of a trip to Asia seen as show of defiance to the West.

A day after signing a mutual defence agreement with North Korea, Putin received a 21-gun salute at a military ceremony in Vietnam, was embraced by two of its Communist leaders and lavishly praised by one of them.

Putin had contributed to "peace, stability and development" in the world, Vietnam's president said.

Putin's visit has drawn criticism from the United States and its allies, who treat the Russian leader as a pariah and have protested that he should not be given a stage on which to defend Russia's war in Ukraine.

Russia and Vietnam signed agreements on issues including energy, underlining Moscow's pivot to Asia after the West imposed sanctions on Moscow over the conflict in Ukraine.

"We are firmly committed to deepening the comprehensive strategic partnership with Vietnam, which remains among the priorities of Russia's foreign policy," Putin was quoted as saying by Russian media.

He was quoted by Russia's TASS news agency as saying the two countries shared an interest in "developing a reliable security architecture" in the region based on not using force and peacefully settling disputes with no room for "closed military-political blocs".

The 11 pacts signed in Hanoi were not on the same level as the landmark mutual defence agreement in North Korea.

But Putin's warm welcome was a public relations achievement for the Russian leader, who has an outstanding International Criminal Court arrest warrant against him over alleged war crimes in Ukraine, charges he denies.

Neither Russia nor Vietnam is a member of the ICC.

"Putin's triumphal reception in Hanoi will mark a counter-point to Russia's recent setbacks," said Carlyle Thayer, emeritus professor at the Australian Defence Force Academy, listing the recent Ukraine conference in Switzerland and new European Union sanctions on Russia.

They were the latest Western sanctions imposed on Russia since its full-scale invasion of Ukraine in February 2022, which Moscow calls a "special military operation".

Putin's public relations blitz has been helped by the fact that Vietnam, unlike North Korea, has friendly relations with the United States and its allies, said Zachary Abuza, a professor at the U.S. National War College.

"Although, there was a lot less of the fanfare and performative aspects then in North Korea, this visit was still important for Putin because Vietnam is actually an important actor in the global economy, not some comically evil pariah state," Abuza said.

SHARED HISTORY

The military ceremony put on to greet Putin, who was embraced by both Vietnamese President To Lam and Prime Minister Pham Minh Chinh, was the kind reserved for the highest heads of state and rolled out when U.S. President Joe Biden and Chinese President Xi Jinping visited Vietnam last year.

The two presidents witnessed the exchange of 11 agreements and memorandums of understanding, including deals on oil and gas, nuclear science and education.

At another event, Lam said Putin continued to lead Russia "overcoming all difficulties and challenges, at the same time contributing to the peace, stability and development in the region and the world."

Abuza underlined Vietnam and Russia's shared Communist history, with tens of thousands of Vietnamese cadres - including current members of the Politburo - having trained in the former Soviet Union.

"The Vietnamese will never forget the assistance that the Soviet Union provided during their war against the United States," Abuza said, nor that Moscow was one of Hanoi's few friends after Communist forces defeated the U.S.-backed South Vietnam in 1975.

U.S., EU CRITICISMVietnam's hosting of Putin was criticised by the United States, now an important partner which upgraded diplomatic relations with Hanoi last year and is Vietnam's top export market, and by the EU.

A U.S. embassy statement this week said no country should be giving Putin a platform to promote Russia's war in Ukraine.

An EU delegation spokesperson in Vietnam said Hanoi had the right to develop its own foreign policy, but said Russia's war in Ukraine proved Moscow did not respect international law.

Despite concern over the visit in the U.S. and its allies, Hanoi may have correctly calculated it will not suffer material consequences, said Murray Hiebert, a senior associate of the Southeast Asia Program at Washington’s the Center for Strategic and International Studies.

One reason, he said, is that Washington heavily relies on its good relations with Vietnam to counter its rivalry with China in the region.

"I don't think it'll have a long-term impact... the U.S. often gives them a bit of a pass," Hiebert said.

https://www.yahoo.com/news/russian-president-putin-arrives-vietnam-194145880.html

US Supreme Court rules against convicted border drug 'mule' in expert testimony dispute

 The U.S. Supreme Court on Thursday ruled against a California woman convicted of smuggling drugs across the U.S.-Mexican border who challenged prosecution expert testimony that cast doubt on her claim that she acted unwittingly as a "blind" drug mule.

The justices, in a 6-3 ruling, upheld a lower court's decision to allow testimony by an expert witness who called into question Delilah Guadalupe Diaz's contention that she did not know that methamphetamine valued at $368,550 was hidden in the door panels of the car she was driving.

The case tested how far law enforcement agents appearing in trials as expert witnesses can go in telling a jury that defendants in certain drug trafficking cases generally have a "guilty mind." A judge in this case allowed an expert witness to testify in the trial that drivers usually know they are being hired to traffic drugs.

A jury in federal court in San Diego found Diaz guilty in 2021 of illegally importing the methamphetamine, a crime that required proving that she knew the drugs were in the car. Diaz was sentenced to seven years in prison.

Diaz's lawyers argued that the testimony violated a provision of the longstanding Federal Rules of Evidence governing the types of evidence allowable in legal cases. The rule bars expert witnesses from opining on the "mental state" of defendants related to an alleged offense and whether they knew they were committing a crime.

U.S. District Judge Anthony Battaglia during the trial let the prosecution's expert witness, a Homeland Security special agent, testify that "in most circumstances, the driver knows they are hired." The expert also told the jury that drug-trafficking organizations generally do not entrust large quantities of drugs to unknowing couriers.

People who smuggle drugs across borders, sometimes called "mules," may do so for profit but also sometimes do it unwittingly, transporting illegal substances that were planted on them. These individuals are often called "blind" mules.

In 2020, border inspectors ordered Diaz, a resident of Moreno Valley, California, to roll down a window of the Ford Focus vehicle she was driving and heard a "crunch-like" sound, later finding 56 packages containing more than 24 kilograms of pure methamphetamine. Diaz denied knowledge of the drugs.

She carried two cellphones - one locked that she could not open - and claimed that the car belonged to a boyfriend she had visited in Mexico whose phone number and residence she could not identify. The car also had a hidden GPS device.

The Supreme Court heard arguments in the case in March.

https://www.yahoo.com/news/us-supreme-court-rules-against-142255415.html

Nestle, Coke take cautious approach to catering to Ozempic users

 Nestle's new food brand for people taking weight-loss drugs like Wegovy will note that the meals are high in protein, fiber and nutrients, but will not name the blockbuster medications, a company executive told Reuters.

The world's largest food maker is keeping the names of the drugs off the packaging due to regulatory concerns, Tom Moe, Nestle USA's president of meals, said in a recent interview. Nestle will instead market its Vital Pursuit line of $5-and-under frozen meals on social media, he said.

"We won’t directly make the connection (to the drugs) on the food package," Moe said.

Nestle's hesitancy to name drugs like Novo Nordisk's Wegovy and Ozempic on its packaging shows the uncertainty facing global food companies as they place big bets on selling products specifically geared toward millions of people taking the appetite-suppressing medicines.

The medications, from a class of drugs known as GLP-1 agonists, threaten to dent profits of snack-makers and fast food chains as people taking them cut way back on the amount of food they consume.

When its fajita melts and pizzas hit store freezers this autumn, Nestle will face a sea of competitors making specific claims about their products targeting people on the medications.

The maker of Biocare, a drink that sells for $4.50 per serving, touts on the packaging that it can "alleviate side effects" such as nausea, for people taking semaglutides, a reference to the active ingredient in Wegovy and Ozempic.

The medications can cause gastrointestinal side effects, but doctors recommend people using them keep eating, especially protein-rich foods, to maintain energy and avoid losing muscle.

Herbalife pitches shakes sold in a bundle for $185.10 that it claims can help people achieve their nutritional needs while on "the shot," as the injectable drugs are sometimes colloquially called.

Retailers like supplement-seller GNC are also looking to capitalize on the trend by introducing a section in stores dedicated to GLP-1 users, selling protein powder and fiber.

Referencing the weight-loss drugs on packaging for Vital Pursuit products could expose Nestle to regulatory scrutiny.

"We're not a medication, we're a food product," Moe said.

Referring to the medications could suggest that the food somehow treats or prevents disease, claims only products approved by the U.S. Food and Drug Administration can make, said Lauren Handel, an attorney specializing in food.

"It's a tricky area where you'd want to be careful about what you say," Handel said. "The safest course of action is not to mention any drugs."

The same rules apply to advertising, she said. Labeling items as "suitable for people on a diet" or as "companions" to the medications may comply with FDA regulations. "Some companies will take more risk," she said.

Nestle declined to say whether it will refer to the drugs in advertisements.

'ABSOLUTE GAME CHANGER'

Herbalife is taking a more direct approach, saying on Facebook: "Using a GLP-1 weight-loss drug? Support your nutritional needs by using Herbalife's GLP-1 Companion Pack."

Herbalife Chief Commercial Officer Frank Lamberti said the company chose GLP-1 instead of recognizable brand names like Ozempic to avoid alienating people taking rival drugs, such as Eli Lilly's Mounjaro and Zepbound, or who have quit taking the medications but still watch their weight.

Robard Corp, which makes Biocare, said it is marketing the drink through a "strong influencer community who are all taking GLP-1s."

Biocare influencer Ashley Dunham of Jacksonville, Florida, said in a TikTok video the product has been an "absolute game changer" when it comes to maintaining her weight after losing 100 pounds (45.4 kilograms).

Coca-Cola and yogurt-maker Danone say many of their products are perfect for people taking the medications because they are either low in sugar or high in protein.

Coke's Fairlife shakes, with up to 42 grams of protein, are frequently touted on social media by people using the medications.

Fairlife does not have any paid partners or influencers who link the shakes with GLP-1s or weight loss, and does not target them with free products or other incentives, a spokesperson said, adding that the company has heard from consumers using the medications that they like the shakes.

Healthy Choice meal maker Conagra Brands also will keep drug names off packaging for food marketed to people using the medications, executives told Reuters this month.

Using the names could turn off those who aren't taking the drugs but would still consider buying the food, said Megan Bullock, a director of strategic insights at Conagra.

Conagra will focus on attributes of its existing products such as protein or fiber content to help consumers using GLP-1s make the connection that the food is suitable for them, said Bob Nolan, the company's vice president of demand science.

Conagra is not currently developing new brands for people using the medications but executives have said it sees opportunity to sell more frozen meals to them.

Kelli Frias, a marketing professor at American University, said consumers do not yet have clear ideas of what to eat while on the medications.

Food companies are “trying to create new associations,” she said. "We don't have those associations in our mind until we're taught them."

https://www.yahoo.com/news/food-companies-ozempic-friendly-snacks-100203428.html

PTC Reports Positive Phase II Huntington’s Data, FDA Lifts Partial Clinical Hold

 PTC Therapeutics announced Thursday that its Huntington’s disease candidate PTC518 is no longer subject to an FDA partial clinical hold after it showed positive interim results from a Phase II study.

Interim results from the PIVOT-HD trial of PTC518 in Huntington’s disease (HD) patients demonstrated the oral small molecule lowered mutant huntingtin (mHTT) protein levels in the blood and cerebrospinal fluid (CSF). PTC also touted “favorable trends” shown on several HD clinical assessments, including Total Motor Score and Composite Unified Huntington's Disease Rating Scale. The candidate was also found to be safe and well-tolerated after 12 months of treatment.

PTC518 lowered mHTT levels in the blood by 22% and 43% at the 5mg and 10mg doses, respectively. For the CSF metric, dose-dependent mHTT was reduced by 21% at the 5mg dose and 43% at the 10mg dosage. In slowing the progression of motor symptoms, a worsening by 2.0 points at the 5mg dosage amount was recorded, while a 1.3 point worsening was found at the 10mg level. By comparison, patients taking the placebo had a worsening of 4.9 points.

“The evidence of both CNS biomarker and early clinical effects at month 12 along with the continued favorable tolerability profile supports the promise of PTC518 to address the need for an effective and safe disease-modifying therapy for patients living with Huntington’s disease,” PTC CEO Matthew Klein said in a statement.

PTC reported that the FDA lifted its partial clinical hold on the candidate based on a data review. In October 2022, the FDA put the program on pause after the agency requested more data to support PTC518’s dosing and duration proposed in the 12-month study, the company told BioSpace at the time. However, PTC continued to enroll patients in other locations worldwide.

Thursday’s positive results for PTC come as other players in the Huntington’s space continue to struggle. Earlier this month, Sage Therapeutics announced that its oral NMDA receptor dalzanemdor had a slight numerical improvement in a Phase II Huntington’s trial. However, no data were provided and in a note to investors William Blair analysts said that the results were “underwhelming” and they remain cautious about Sage’s candidate as the small changes are not seen as “definitive.”

https://www.biospace.com/article/ptc-reports-positive-phase-ii-huntington-s-data-fda-lifts-partial-clinical-hold/

Lilly Takes More Legal Actions Over Compounded Tirzepatide, Warns About Counterfeits

 Eli Lilly on Thursday announced it has filed additional lawsuits against medical spas, wellness centers and other similar entities, which allegedly have been selling unapproved compounded versions of the pharma’s best-selling GLP-1 receptor agonist tirzepatide.

According to Lilly, the defendants in the lawsuits have misrepresented their products as either Mounjaro or Zepbound—the only two FDA-approved brands for tirzepatide—indicated for type 2 diabetes and chronic weight management, respectively. The defendants also refer to these FDA approvals to mislead customers to believe that these compounded products have cleared regulatory scrutiny, Lilly contends.

In addition, the defendants use Lilly’s study data in their advertising which is “deceiving consumers to believe the defendants’ compounded drugs were part of Lilly’s clinical trials,” the pharma alleges.

Lilly also published a lengthy open letter on Thursday, warning patients of the harms of compounded and counterfeit pharmaceutical products—as well as blasting “certain practices” of other clinics and spas regarding Mounjaro and Zepbound.

In the open letter, Lilly emphasized that its GLP-1 products “are indicated for the treatment of serious diseases” and are “not approved for—and should not be used for—cosmetic weight loss.” The pharma also said that it does not endorse the use of Mounjaro and Zepbound outside of its approved indications, and that patients should only use these medications following the prescription of a licensed healthcare professional.

Lilly also took aim at the increasingly common sales of Mounjaro and Zepbound online, particularly on social media which the pharma says involves counterfeit, fake or compounded versions of these treatments. “Social media is not a replacement for a healthcare professional,” Lilly warned, noting that purchasing these products through unregulated channels could put patients at risk.

In September and October 2023, Lilly sued several medical spas and wellness clinics for compounded versions of Mounjaro and Zepbound. The lawsuits alleged that these defendants infringed on Lilly’s trademark and violated federal and state consumer protection laws.

However, in April 2024, a Florida judge dismissed Lilly’s case against one compounding pharmacy, ruling the pharma was arguing to use state law to implement federal regulations—the Federal Food, Drug, and Cosmetic Act. In doing so, Lilly was trying to pre-empt federal law, U.S. District Judge Roy Altman ruled.

Novo Nordisk, Lilly’s main competitor in the lucrative obesity market, is also clamping down on compounded and counterfeit version of its own GLP-1 analog semaglutide, which are sold under the brand names Ozempic and Wegovy. The Danish drugmaker began its legal campaign in June and July 2023, claiming early victory in February 2024 with a Florida court issuing a permanent injunction against one of the defendants.

https://www.biospace.com/article/lilly-takes-further-legal-actions-over-compounded-tirzepatide-warns-about-counterfeits/

What's Going On With Tempest Therapeutics

 Shares of Tempest Therapeutics Inc TPST are trading lower on Thursday, with a session volume of 21 million as per data from Benzinga Pro.

The company announced new data from the ongoing Phase 1b/2 clinical study on amezalpat2 (TPST-1120).

The drug candidate delivered a six-month improvement in median overall survival advantage when combined with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm show:

• 21-month median OS for the amezalpat arm versus 15 months for the control arm, a six-month survival advantage.
• 20/40 patients remain in survival follow-up in the amezalpat arm, compared to 9/30 patients in the control arm.
• 0.65 hazard ratio for OS, revealing a stable HR since the top-line analysis 10 months earlier when the HR was 0.59.
• A manageable safety profile is consistent with Phase 1 data.

The earlier top-line data analysis, dated April 20, 2023, had a median follow-up of 9.2 and 9.9 months for the amezalpat and control arms, respectively and showed:

• A confirmed objective response rate of 30% for the amezalpat arm versus 13.3% for the control arm.
  • Biomarker subpopulation findings were consistent with the mechanism of action of amezalpat. Patients with b-catenin activating mutations (21% in this study (n=7)) showed a cORR of 43% and a disease control rate (DCR) of 100% in the amezalpat arm.
  • The amezalpat arm was consistently active across both PD-L1 positive and PD-L1 negative tumors, with a cORR of 27% in the amezalpat arm compared to 7% for the control arm in PD-L1 negative tumors.

Amezalpat remains well tolerated, with safety data comparable between the two arms.

HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030. Every year, more than 900,000 people worldwide are diagnosed with HCC.

https://www.benzinga.com/general/biotech/24/06/39412888/whats-going-on-with-cancer-focused-tempest-therapeutics-stock-on-thursday

Nurix 'Clear Win' In Leukemia Treatment

 Nurix Therapeutics (NRIX) posted a "clear win" in leukemia treatment on Monday, but the biotech stock gave up some of its gains, giving up a potential breakout.

The company tested its treatment, dubbed NX-5948, in patients with relapsed or refractory forms of chronic lymphocytic leukemia, or CLL. Refractory means the cancer didn't respond to prior treatment, and Nurix noted the patients were "heavily pretreated," having received two to 14 previous drugs.

Overall, 69.2% of patients responded to the oral treatment. Some showed responses as early as eight weeks into treatment. Those responses deepened over time, Nurix said in its news release.

Needham analyst Gil Blum said the results are a "clear win" for the biotech stock and the drug class. Nurix's approach degrades a protein called BTK. Doing so blocks defective B cells, which can drive cancers like CLL and B-cell lymphomas.

"These results are striking given the heavily pretreated nature of patients," Blum said in a report. "We are highly encouraged by the robustness of these results and consider them potentially best in class."

https://www.investors.com/news/technology/biotech-stock-nurix-therapeutics-positive-trial-leukemia-treatment/