FDA approves 2nd Alzheimer’s drug that modestly slows disease

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WASHINGTON — U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. 

The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai. 

The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. 

Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments. 

“I’m thrilled to have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.” 

Both Kisunla and the Japanese drug, Leqembi, are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s: sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit. 

The new drug’s approval was expected after an outside panel of FDA advisers unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels. 

Costs will vary by patient, based on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 — more than the $26,500 price of a year’s worth of Leqembi. 

The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming via brain scans that patients have minimal plaque. 

More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multistep process needed to get a prescription. 

The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion. 

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study, including 20% of patients with microbleeds, were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety. 

Kisunla is infused once a month compared to Leqembi’s twice-a-month regimen, which could make things easier for caregivers who bring their loved ones to a hospital or clinic for treatment.
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«Укрзалізниця» підготувала нові правила перевезення тварин і закликає до їхнього обговорення

SocNet Новини, Політика, Суспільство 0 Comment

Перед затвердженням Державною регуляторною службою України проєкт наказу з усіма змінами буде винесено на суспільне обговорення
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Exiled Hong Kong activists feel strain after bounty imposed on them

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BOSTON, MASSACHUSETTS — Two exiled Hong Kong activists say bounties imposed on them last year are causing fear and anxiety as they conduct their advocacy work from U.S. soil amid concerns for their safety.

Anna Kwok expected to face retaliation from the Hong Kong government when she became the executive director of the Washington-based advocacy organization Hong Kong Democracy Council in November 2022. Hong Kong authorities imposed a bounty on her and seven others on July 3, 2023.

Frances Hui, who is the policy and advocacy coordinator for the U.S.-based Committee for Freedom in Hong Kong Foundation, was one of an additional five who had bounties imposed on them in December.

The 13 are accused of violating a controversial national security law that went into effect in the former British colony in July 2020.

Despite being mentally prepared, Hui and Kwok said they felt shocked when the Hong Kong government issued arrest warrants and bounties worth $127,635 for them and the other overseas Hong Kong activists last year. Hui said the bounty felt like “a death certificate” as it confirmed she would not be able to set foot in Hong Kong again.

“After learning about the bounty imposed against me, I suddenly felt like everything was out of my control because I could no longer get in touch with my family and close people in Hong Kong,” she said, adding that the event pushed her life onto a completely different path.

“I’m officially a wanted fugitive, and whoever in Hong Kong is associated with me will get into trouble,” Hui told VOA by phone.

While Hui described the experience as “jarring and shocking,” Kwok said she didn’t realize how the bounties could affect her until her bank account in Hong Kong was frozen.

“At first, I was surprised for only 10 seconds and immediately went into work mode, thinking about how to use this incident to advance our advocacy agenda in media interviews,” said Kwok.

“When I checked my Hong Kong bank account at 11 p.m. on July 3, 2023, I noticed my asserts were frozen and I suddenly realized the real-life implications of the bounty on my head,” Kwok told VOA by phone.

These activists “betrayed their country, betrayed Hong Kong, disregarded the interests of Hong Kong people, and continue to endanger national security even when abroad,” the chief superintendent of Hong Kong’s National Security Department, Li Kwai-wah, said at a December 14 press conference.

Eric Lai, a research fellow at Georgetown University’s Center for Asian Law in the United States, said the Hong Kong government hopes to create a chilling effect that will further disconnect people in Hong Kong from overseas activists by issuing arrest warrants and bounties.

“It’s a silencing tactic to both people around the bounty holders and the bounty holders themselves,” he told VOA by phone, adding that it is part of the Hong Kong government’s efforts to surveil, harass and intimidate political dissidents in exile.

In addition to imposing bounties on more than a dozen activists, Hong Kong authorities canceled the passports of overseas activists last month. In the U.K., three men were charged in May with spying on members of the Hong Kong diaspora community on behalf of the territory’s intelligence service.

Threat to mental health, personal safety

Apart from targeting overseas activists, Hong Kong authorities have interrogated family members of the activists, including Hui’s mother and Kwok’s brothers and parents.

Hui said the interrogations of her family members made her realize that her activism abroad could affect those who are still in Hong Kong. She said that is one way that Hong Kong authorities have limited her freedom.

“It’s a very lonely experience to know that whatever I do could be connected to people who are associated with me; but I also know that if I stop my activism now, that’s exactly what the Chinese Communist Party would want, to intimidate and silence me,” she said.

In addition to the sense of loneliness, Hui said the bounty has increased her fear of threats to her safety.

“I have become extra cautious about talking to people, even those in the Hong Kong diaspora community, and my heightened sensitivity toward security issues has also contributed to my increased level of anxiety,” she said, adding that she is trying hard not to let fear dictate her advocacy work.

As for Kwok, the fear for her safety became real when she began to receive death threats shortly before leaders convened for an Asia-Pacific Economic Cooperation summit, held in November in San Francisco. At the time, she was planning to attend protest rallies against Chinese President Xi Jinping.

“I started receiving death threats and threats of raping me in my inbox, and those accounts are not afraid of using brutal language or insinuating physical harm against me,” she told VOA. She said the messages would appear in her inbox in a coordinated fashion.

While she was shocked about the explicitness of those threats, she tried to take steps to rein in her fear, including maintaining regular contact with close friends, playing with her cats or diving into the world of fiction.

These steps “help to assure me that things are okay and I’m doing something impactful, which is an important realization to me,” Kwok said.

Despite their efforts to overcome the fear created by the bounties, Hui and Kwok say the Hong Kong government’s efforts to launch transnational repression are a threat to the entire diaspora community.

“I think my personal experience shows that there are still many gaps in implementing protection mechanisms against transnational repression in many countries,” Kwok said, adding that the moves initiated by Hong Kong authorities are damaging trust within the diaspora community.

While Hong Kong authorities try to isolate some overseas activists, Hui said she will continue to concentrate her advocacy efforts on speaking up for activists who have been imprisoned in Hong Kong.

“There is a sense of mission for me, and I hope I can continue to advocate for those who can’t,” she said.

In response to criticisms made by the activists, the Hong Kong government said the extraterritorial effect of the national security law is fully in line with the principles of international law and common practices adopted by several countries.

“Absconders should not think they can evade criminal liability by absconding from Hong Kong, [because] ultimately, they will be held accountable for their acts constituting serious offences endangering national security and be sanctioned by law,” a Hong Kong government spokesperson told VOA in a written response.
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Sri Lanka to save $5bn from bilateral debt deal  

CensorBiz Бізнес, Новини, Статті, Суспільство 0 Comment

Colombo, Sri Lanka — Sri Lanka will save $5 billion following the restructure of its bilateral debt, much of which is owed to China, through slashed interest rates and longer repayment schedules, the president said Tuesday.

The island nation defaulted on its foreign borrowings in 2022 during an unprecedented economic crisis that precipitated months of food, fuel and medicine shortages.

President Ranil Wickremesinghe said a deal struck last week had secured a moratorium on debt payments until 2028, extending the tenure of loans by eight years and cutting interest rates to an average of 2.1%.

Wickremesinghe said bilateral lenders led by China, the government’s largest single creditor, did not agree to take a haircut on their loans, but the terms agreed would nonetheless help Sri Lanka.

“With the restructure measures we have agreed, we will make a saving of $5.0 billion,” Wickremesinghe told parliament in his first address to the legislature since the debt deal.

Some of Sri Lanka’s loans from China are at high interest rates, going up to nearly 8.0% compared to borrowings from Japan, the second largest lender, at less than 1.0%.

Sri Lanka struck separate deals with China and the rest of the bilateral creditors, including Japan, France and India.

Bilateral creditors account for 28.5% of Sri Lanka’s outstanding foreign debt of $37 billion, according to treasury data from March. This excludes government-guaranteed external loans.

China accounts for $4.66 billion of the $10.58 billion that Sri Lanka has borrowed from other countries.

Wickremesinghe said he expected to complete shortly the restructure of a further $14.7 billion in external commercial loans, including $2.18 billion from the China Development Bank.

Sri Lanka’s 2022 crisis sparked months of public protests that eventually forced the resignation of then-president Gotabaya Rajapaksa after an angry mob stormed his compound.

Wickremesinghe said the nation was bankrupt when he took over and he hoped the $2.9 billion International Monetary Fund bailout he secured last year would be the island’s last.

Colombo had gone to the IMF, the international lender of last resort, on 16 previous occasions and the debt restructuring is a condition of the IMF bailout.
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Trump seeks to set aside New York verdict hours after Supreme Court ruling

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New York — Donald Trump’s lawyers on Monday asked the New York judge who presided over his hush money trial to set aside his conviction and delay his sentencing scheduled for later this month.

The letter to Judge Juan M. Merchan cited the U.S. Supreme Court’s ruling earlier Monday and asked the judge to delay Trump’s sentencing while he weighs the high court’s decision and how it could influence the New York case, the people said.

The people could not discuss details of the letter before it was made public and spoke to The Associated Press on condition of anonymity.

The Supreme Court on Monday ruled for the first time that former presidents have broad immunity from prosecution.

Trump was convicted on 34 counts of falsifying business records, arising from what prosecutors said was an attempt to cover up a hush money payment just before the 2016 presidential election.

Merchan instituted a policy in the run-up to the trial requiring both sides to send him a one-page letter summarizing their arguments before making longer court filings. He said he did that to better manage the docket, so he was not inundated with voluminous paperwork.
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