The U.S. Supreme Court on Monday declined to hear Novartis Pharmaceuticals Corp's bid to revive a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China's HEC Pharm Co Ltd.
The justices turned away an appeal by Novartis of a lower court's decision to cancel the patent, a ruling that paved the way for some generic versions of Gilenya.
https://finance.yahoo.com/news/us-supreme-court-rebuffs-novartis-133048462.html
A panel of U.S. Food and Drug Administration advisers on Monday unanimously voted in favor of Innoviva Inc's experimental antibiotic in the treatment of serious bacterial infections, typically associated with hospitalizations, the company said.
Innoviva is seeking the U.S. health regulator's nod for the drug, sulbactam-durlobactam, as a treatment for hospital‐acquired and ventilator‐associated bacterial pneumonia caused by susceptible strains of the bacteria called acinetobacter baumannii-calcoaceticus complex.
The FDA panel voted 12-0 in favor of the drug as a potential treatment for serious infections caused by the bacteria, including multidrug-resistant strains.
Entasis Therapeutics, which was acquired by Innoviva last year, is developing the drug, its lead asset, in partnership with Zai Lab Ltd.
The health regulator, which usually follows the recommendations of its expert panel but is not obligated to do so, is expected to make its final decision by May 29 on the use of the drug.
If approved, the company will "look to explore commercial availability sometime later in the year", David Altarac, chief medical officer of Entasis Therapeutics, told Reuters ahead of the panel meeting.
Sulbactam-durlobactam is an intravenous investigational drug, which showed a favorable safety profile and statistically significant reduction in nephrotoxicity, or damage caused to kidneys, in a late-stage trial when compared to a key last-line antibiotic therapy, colistin, in patients with infections caused by the bacteria.
https://www.yahoo.com/news/us-fda-panel-backs-innovivas-215036013.html
Violet Zhu, a Shanghai-based electronic components exporter, has been attending jewellery auctions and chatting on social media forums on the subject this year, looking to invest in rubies and diamonds.
"I don't have the brain for stock investments, and I am waiting to redeem mutual fund products once they break even. But in the meantime, I have been continuously buying gems," says Zhu.
Zhu says she is searching for oddly-shaped rubies of higher grades, hoping the value of those little gems will surge with time. She is not alone.
Jewellery and precious metals consumption in China soared 37.4% in March from a year earlier underpinning a 13.6% jump for the quarter and topping the list of items that stoked a surge in first-quarter retail sales, official data showed on Tuesday.
China's economy grew at a faster-than-expected pace in the first quarter, with retail sales rising 10.6%, beating forecasts for a 7.4% increase by a large margin.
The interest in precious metals is a worrying indicator that China's efforts to revive its economy via domestic spending, after years of strict COVID curbs, may not be working.
"High-end consumption gives us a bit of a surprise but overall the weak recovery story remains intact," said Marco Sun, chief financial analyst at MUFG Bank (China).
The appeal of jewellery and gold has risen after the biggest global banking crisis in more than a decade, as the failure of Silicon Valley Bank and the forced sale of lender Credit Suisse rocked investor confidence.
"Consumer interest in precious metals (comes) as a potential safe haven and inflation hedge, as many consumers do not expect low inflation in China to continue," said Ben Cavender, managing director at China Market Research Group.
https://finance.yahoo.com/news/chinese-households-turn-jewellery-gold-071956982.html
The U.S. Internal Revenue Service declared on Tuesday that it is completing its first "normal" tax filing season since the COVID-19 pandemic struck in 2020, with a backlog of millions of unprocessed returns from previous years fully cleared.
New IRS Commissioner Danny Werfel told reporters that the initial spending of $80 billion in new IRS funding helped purchase new scanning technology that has allowed paper returns to be digitized and quickly processed.
The COVID pandemic led to a three-month filing delay in 2020 followed by a one-month delay in 2021. The delays collided with staffing shortages to pile up a massive backlog of some 23.5 million individual and business tax returns by February 2022 that needed some form of manual processing, according to the National Taxpayer Advocate's office.
Ahead of the 2023 tax season, which has a midnight Tuesday filing deadline, the IRS hired 5,000 new taxpayer service agents to cut down call waiting times, and with the new scanning technology, it was able to clear the backlog of all error-free returns, Werfel said, leaving only those with questions, audits or other issues to be resolved.
A U.S. Treasury spokesperson said the IRS ended 2022 with a backlog of 1.4 million unprocessed individual and business returns and those were cleared by mid-March.
Including the new 5,000 taxpayer services personnel, the IRS plans to hire some nearly 20,000 new staff over two years as it deploys new funding from the climate-focused Inflation Reduction Act.
Republicans in the U.S. House of Representatives have targeted the $80 billion in new IRS funding as part of their spending cut demands in exchange for raising the $31.4 trillion U.S. debt ceiling.
The funding, aimed at beefing up enforcement and audits for wealthy taxpayers and business partnerships, modernizing computer systems and improving taxpayer services, comes on top of the agency's annual operating budget.
Werfel said the funding was making an "immediate, meaningful difference to deliver the service American taxpayers deserve on the phone, in person and online" with more improvements in coming years.
https://finance.yahoo.com/news/u-irs-clears-massive-backlog-090239991.html
The artificial intelligence behind ChatGPT, the homework-drafting chatbot that some schools have banned, is coming to more students via the company Chegg Inc.
The U.S. educational software maker has combined its corpus of quiz answers with the chatbot’s AI model known as GPT-4 to create CheggMate, a study aide tailored to students, CEO Dan Rosensweig told Reuters last week.
"It's a tutor in your pocket," he said ahead of its announcement of CheggMate on Monday.
The software will adapt to students by processing data on what classes they are taking and exam questions they have missed, personalizing practice tests and guiding study in a way generalist programs like ChatGPT cannot, Rosensweig said. It will be available next month for free initially, Chegg said.
The release is poised to widen what pupils do with AI just as educators are grappling with its consequences. Last year’s launch of ChatGPT led students to turn in assignments written coherently by the chatbot, letting some sidestep coursework and forcing faculty to vet their integrity.
The Los Angeles Unified School District has blocked access to ChatGPT on its devices and networks pending more analysis, it told Reuters, while institutions such as France’s Sciences Po banned it out of concern it plagiarized sources. Still other teachers have encouraged ChatGPT’s usage if disclosed, for purposes such as critique.
Rosensweig said Chegg focuses on math and the sciences, not the essay drafting that has challenged schools. It also lets teachers restrict review of answers to questions on current exams.
Accuracy remains a problem for AI models, which predict what to say next without a grasp of facts. Rosensweig said Chegg has structured and checked its answers to ensure accuracy.
Asked if AI will prompt Chegg to shrink its pool of 150,000 experts contributing to its content, he said the company already balances humans with technology. CheggMate likely will decrease its cost of content and boost profitability over time, he said.
by Steve Watson via Summit News,
Now it is firmly ensconced among the climate change cult that eating meat is killing the planet and you must ‘eat ze bugs’, the same people have a new target, rice.
“Rice cannot be ignored.”
The Food and Agriculture Organization notes that “Rice is one of the most important staple foods in the world. Over 50 percent of the world population depends on rice for about 80 percent of its food requirements. About 95 percent of the global output of rice is produced and consumed in developing countries.”
What is this really about?
GSK plans to buy Canada-based drug developer Bellus Health Inc in an all-cash deal for $2 billion as the British drugmaker expands its bet on respiratory therapies.
The move to replenish its pipeline comes as GSK investors fret about whether there is enough in the medicine cabinet to keep the momentum going into the next decade with expected loss of patent protection of one of its key compounds.
At the heart of the deal - announced by both companies on Tuesday - is the experimental drug, camlipixant, which is in late-stage development as a treatment for refractory chronic cough (RCC).
The condition can cause patients to cough more than 900 times a day for more than a year. Some 10 million patients globally suffer from it and so far, there are no approved therapies.
GSK's offer of $14.75 per share is more than double Bellus' closing price of $7.26 on the Nasdaq on Monday.
The Bellus deal expands GSK's existing respiratory portfolio, including Nucala and Trelegy, which generated more than a combined 3 billion pounds ($3.73 billion) last year.
Camlipixant is up against Merck's rival drug, gefapixant, for RCC patients.
Early in 2022, gefapixant was denied approval by the U.S. regulator, which sought more information on its effectiveness - but the U.S. drugmaker is expected to resubmit an application for another review later this year.
Still, some analysts say camlipixant - should both drugs be eventually approved - could emerge as preferred option with a superior safety profile.
Jefferies analysts estimated camlipixant could generate peak U.S. sales of $1.2 billion, in a note earlier this month.
DEAL FLURRY
Investors are particularly interested in GSK's future plans, given the pending loss of patent protection in 2027 for dolutegravir, the compound that forms part of four GSK's HIV treatments, which puts more than 5 billion pounds of sales at risk.
The company is leaning in part on the prospects of its own vaccine targeted at the respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths a year, to at least partially offset that loss.
