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Thursday, September 14, 2023

India's Nipah virus trackers gather samples from bats, fruit

 Researchers have fanned out in India's southern state of Kerala to collect samples of fluid from bats and fruit trees in a region where the deadly Nipah virus has killed two people and three more have tested positive.

The state is battling its fourth outbreak since 2018 of a virus for which there is no vaccine, and which spreads through contact with the body fluids of infected bats, pigs or people, killing up to 75% of those infected.

"We are testing human beings ... and at the same time experts are collecting fluid samples from forested areas that could be the hotspot for the spread," Veena George, the state's health minister, told Reuters.

Samples of bat urine, animal droppings and half-eaten fruit were collected from Maruthonkara, the village where the first victim lived, set beside a 300-acre (121-hectare) forest home to several bat species.

Fruit bats from the area had tested positive for the Nipah virus during an outbreak in 2018, the state's first.

"We are in a stage of hypervigilance and detection," George said, adding that 77 people had been identified as being at high risk of infection.

Nearly 800 people have been tested over the last 48 hours in the state's district of Kozhikode, with two adults and a child put in hospital for observation after proving positive.

Public offices, government buildings, educational centres and religious institutions were shut in nine villages of the district, while public transport was suspended in the area at risk.

The neighbouring states of Karnataka and Tamil Nadu have ordered tests for visitors from Kerala, with plans to isolate any who show symptoms of influenza.

The virus can infect a range of animals, fuelling the chances of spread. It can be caught either through direct contact or by consumption of contaminated food.

It was first identified in 1999 during an outbreak of illness among pig farmers and others in close contact with the animals in Malaysia and Singapore.

Outbreaks are sporadic and previous infections in South Asia were traced to consumption of items contaminated with bat excreta.

Kerala's first Nipah outbreak killed 21 of the 23 infected, while subsequent outbreaks in 2019 and 2021 killed two people.

In May, a Reuters investigation showed parts of Kerala among the places most at risk globally for outbreaks of bat viruses, as the clearing of forests for development throws people and wildlife into closer contact.

https://news.yahoo.com/indias-nipah-virus-trackers-gather-090515857.html

FDA to seek public opinion before banning popular cough syrup ingredient

The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency's list of ingredients for over-the-counter (OTC) use.

The FDA's clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.

If the FDA concurs with the panel's view, it will first issue a proposed order removing phenylephrine from the list of ingredients that are allowed in OTC drugs, and seek public comment on it.

After considering the comments, if the FDA continues to conclude phenylephrine is not effective, the agency would issue a final order on it and work with manufacturers to reformulate products to effectively treat symptoms of cold or allergies.

Meanwhile, a lawsuit was filed against Johnson & Johnson and Procter & Gamble, which makes Vicks NyQuil, accusing the companies of deceiving consumers about decongestant cold medicines.

Kenvue's Tylenol and GSK's Advil are among the prominent cough and cold syrups containing phenylephrine that are sold in the United States. Johnson & Johnson spun off its consumer healthcare unit as Kenvue this year.

Besides cough syrup, phenylephrine is also an ingredient used in nasal sprays, but the agency said that its order would only be related to the oral drugs and not the spray form.

https://www.yahoo.com/news/us-fda-seek-public-opinion-160926270.html

China boosts liquidity with medium-term policy tool

 China's central bank rolled over maturing medium-term policy loans while keeping the interest rate on them unchanged on Friday, boosting liquidity after a similar move the previous day.

Market participants believe that a weakening Chinese yuan has constrained the central bank's efforts to aggressively lower interest rates after two reductions to the medium-term policy rate since June. Authorities may instead ramp up liquidity to support the economic recovery.

The People's Bank of China (PBOC) said it was keeping the rate on 591 billion yuan ($81.2 billion) worth of one-year medium-term lending facility (MLF) loans to some financial institutions unchanged at 2.50% from the previous operation.

Friday's decision was intended to keep "banking system liquidity reasonably ample" and quarter-end cash conditions stable, the PBOC said in an online statement.

All 33 market watchers polled by Reuters this week predicted no change to the MLF rate.

On Thursday, the PBOC took a similar step to boost liquidity in the financial system, announcing that it would cut the amount of cash that banks must hold as reserves, after lowering key policy rates last month to aid the economic recovery.

With 400 billion yuan worth of MLF loans set to expire this month, the operation resulted in a net 191 billion yuan of fresh fund injections into the banking system.

"The PBOC's decision on Thursday to cut reserve requirement ratio (RRR) has effectively ruled out an interest rate reduction to the MLF rate," said Ken Cheung, chief Asian FX strategist at Mizuho Bank.

"But the higher MLF injection suggested that the easy monetary policy stance is in line with the RRR cut."

Cheung added that using liquidity instruments could ease strong interest rate cut expectations in the short term to reduce the impact on the yuan.

"The purpose of the PBOC's move was to replenish market liquidity," said Marco Sun, chief financial market analyst at MUFG Bank (China).

BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons.

Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease.

In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than a placebo in inhibiting liver scarring, according to the federal clinical trials database.

BMS’ decision to nix the siRNA comes on the heels of Madrigal Pharmaceuticals’ announcement on Wednesday that its NASH treatment, resmetirom, was approved for priority review by the FDA with a decision expected by March 14, 2024. Company shares jumped over 200% in December after the candidate hit both primary endpoints and a secondary endpoint in a Phase III trial. Madrigal also announced that the FDA is not planning to hold an advisory committee meeting to discuss the application.

Thursday’s announced BMS pipeline cuts also included an anti-TIGIT solid tumor program studying the efficacy of the antibody in non-small cell lung cancer (NSCLC), which is usually less responsive to chemotherapy and radiation therapy than small cell lung cancer, according to the National Cancer Institute. However, the clinical trial had only enrolled one patient before being terminated, with BMS citing “safety reasons, adverse change in the risk/benefit,” according to the federal clinical trials database.

Nonetheless, BMS is still pressing forward with an early stage, bispecific anti-TIGIT it licensed from Agenus in 2021 for $200 million upfront, with another $1.36 billion up for grabs in milestone payments.

However, the technology suffered a significant setback in May 2022 after Roche’s Genentech posted disappointing Phase III results casting doubt over other companies developing their own anti-TIGIT drugs. Then, last month, Genentech provided a short update for its Phase III SKYSCRAPER-01 study, releasing immature but nevertheless promising overall survival data for its anti-TIGIT immunotherapy tiragolumab in patients with locally advanced or metastatic non-small cell lung cancer.

But it’s not all good recent news for the sector. In July 2023, Novartis ended its agreement with BeiGene for option rights to ociperlimab, an anti-TIGIT checkpoint inhibitor, less than two years after the collaboration began. The Swiss pharma decided not to proceed with a Phase III study of ociperlimab in NSCLC or a Phase II study of the drug in triple negative breast cancer.

Four early-stage BMS clinical programs also got the axe, according to the company’s Thursday announcement. They included a CD47xCD20 bispecific program, a molecular glue for acute myeloid leukemia, as well as a receptor-protein kinase 1 (RIPK1) inhibitor being investigated as an autoimmune disease treatment.

At the same time, BMS is looking to expand its registrational assets over the next 18 months from six to 12. That includes: a CD19-directed NEX T cell therapy for immunologic diseases, a cell therapy targeting GPRC5G, a potential therapeutic target in multiple myeloma, a BCMA x CD3 T-cell engager going into Phase III trials, a potential first-in-class protein degrader going into a Phase III first-line large B-cell lymphoma, an androgen receptor degrader going into metastatic castration-resistant prostate cancer trials, as well as a potential best-in-class BET inhibitor for myelofibrosis.

The company also cited 25 indication expansion opportunities as well as nine “high-potential early assets expected to advance in the pipeline.” CMO Samit Hirawat said in a statement that BMS’ “integrated approach to R&D will allow us to maximize innovation and get more medicines to more patients faster.”

https://www.biospace.com/article/bms-culls-two-mid-stage-four-early-stage-clinical-programs/

As Historic Auto Union Strike Starts, White House Prepares Emergency Aid

 Update (2320ET): For the first time in history that the 146,000-member union has simultaneously gone on strike against Ford, General Motors(GM) and Stellantis, according to Reuters.

"Tonight, for the first time in our history, we will strike all three of the Big Three at once," UAW President Shawn Fain says.

Judge temporarily halts NY fraud trial against Trump, pending appeal

 A New York state appeals court judge on Thursday temporarily halted the scheduled Oct. 2 trial in New York Attorney General Letitia James' fraud lawsuit against Donald Trump and his family business, a spokesman for the court said.

The order came after the former U.S. president sued Justice Arthur Engoron, the trial judge overseeing the case, accusing him and James of defying a court order that could narrow the lawsuit, according to a report in the Daily Beast.

According to the court spokesman, appeals court Justice David Friedman granted an interim stay of the trial, and referred the matter to a five-judge panel, which expects to rule in the last week of September.

The trial could still begin on Oct. 2 depending on how the appeals court, known as the First Department, rules.

Friedman's stay does not apply to a scheduled Sept. 22 hearing before Engoron on both sides' motions for summary judgment, which can proceed as planned, the court spokesman said.

James wants a ruling that Trump's financial statements were fraudulent, while the defendants want most or all of the attorney general's claims dismissed. Engoron has said the trial could last until near Christmas.

Lawyers for Trump did not immediately respond to requests for comment. James' office did not immediately respond to similar requests.

James has said a "mountain of evidence" shows how Trump and his associates lied over a decade about his assets and net worth, which she says may have been inflated by as much as $3.6 billion, to obtain better terms on loans and insurance.

She is seeking a $250 million fine, and to bar Trump and his sons Donald Trump Jr and Eric Trump from leading the family business, the Trump Organization. Her lawsuit in September 2022, after a three-year probe.

In July, the appeals court said statutes of limitations may preclude James from suing over claims that arose before July 13, 2014, or Feb. 6, 2016, and said Engoron should decide which could proceed.

Bridgewater Widens Lead in China Race as Returns Outclass Rivals

 

  • Firm’s onshore China assets surpassed $4.1 billion last month
  • Bridgewater All Weather Plus No. 2 fund up 11% through August

Bridgewater Associates LP’s flagship China fund is trouncing the performance of its peers, helping to expand the hedge fund’s leadership in the race among global firms looking to woo the nation’s wealthy investors.

Onshore China assets under management at the Westport, Connecticut-based investment company climbed to more than 30 billion yuan ($4.1 billion) as of August, after doubling last year to more than 20 billion yuan, according to people familiar with the matter, asking not to be identified discussing confidential information.

https://www.bloomberg.com/news/articles/2023-09-15/bridgewater-widens-lead-in-china-race-as-returns-beat-rivals