Category: 3. Business

  • Leukemia treatment based on U-M research gets FDA approval – The University Record

    1. Leukemia treatment based on U-M research gets FDA approval  The University Record
    2. Karmanos Physician-Scientist Led Clinical Trial Studies, Preceding FDA-Approval of New Targeted Inhibitor for AML Patients  McLaren Health
    3. Kyowa Kirin (TSE:4151): Assessing Valuation After FDA Green Light for KOMZIFTI in AML Treatment  simplywall.st
    4. Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Komzifti™ (ziftomenib)  GlobeNewswire
    5. Wilson Sonsini Advises Kura Oncology on Patent and Trademark Matters Related to KOMZIFTI’s FDA Approval  Wilson Sonsini

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  • Bank of Japan rate hike case backed by strong exports and elevated inflation | snaps

    Bank of Japan rate hike case backed by strong exports and elevated inflation | snaps

    Both headline and core inflation Japanese rose to 3.0% year-on-year in October (vs 2.9% in September, 3.0% market consensus). Food prices rose the most, 6.4%, while entertainment and transportation/communication also rose solidly by 2.6% and 3.6%, respectively. Utilities continued to rise as the government subsidy program ended.

    On a monthly basis, inflation rose by 0.4% month-on-month, seasonally adjusted, driven by goods and services rising 0.3% and 0.4% each. Typically, companies adjust final prices in October, and they are clearly passing increased input costs on to consumers. This development is likely welcomed by the BoJ, which seeks a virtuous cycle between solid wage growth and sustained inflation.

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  • Navigating Regulatory Waters with Medical Devices

    Navigating Regulatory Waters with Medical Devices

    Brigid DeCoursey Bondoc – FDA + Healthcare Regulatory and Compliance Partner, Morrison Foerster

    Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues. As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.

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  • US FDA investigates Takeda's blood disorder drug after pediatric death – Reuters

    1. US FDA investigates Takeda’s blood disorder drug after pediatric death  Reuters
    2. US FDA investigates death tied to Takeda’s blood disorder drug  AOL.com
    3. FDA launches investigation into Takeda’s Adzynma following reported pediatric death  Fierce Pharma
    4. Takeda Pharmaceuticals’ Genetic Disease Therapy Under FDA Probe After Pediatric Patient Dies  Stocktwits
    5. US FDA investigates Takeda’s blood disorder drug after pediatric death  The Mighty 790 KFGO

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  • Novo Nordisk Patients in Denmark Receive Compensation for Vision Loss Linked to Wegovy and Ozempic

    Novo Nordisk Patients in Denmark Receive Compensation for Vision Loss Linked to Wegovy and Ozempic

    This article first appeared on GuruFocus.

    Novo Nordisk (NVO, Financials) saw renewed attention after Denmark’s patient compensation authority approved payouts to four individuals who experienced vision loss while taking semaglutide-based drugs Wegovy and Ozempic. The patients were awarded a total of 800,000 Danish crowns following a specialist review. One additional claim was rejected.

    The authority said the cases were complex because semaglutide has been linked in very rare situations to non-arteritic anterior ischemic optic neuropathy, a condition that can cause permanent vision loss. European regulators added NAION to product labels in June, noting it may occur in up to 1 in 10,000 patients.

    Denmark’s compensation authority, which operates independently and is funded by the state, has received 43 claims related to alleged semaglutide-associated vision issues. The rulings do not assign legal liability to Novo Nordisk.

    Semaglutide remains central to Novo Nordisk’s diabetes and weight-management portfolio, and demand for both medications remains elevated.

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  • G20 draft declaration defies US with ‘climate change’ references, source says

    G20 draft declaration defies US with ‘climate change’ references, source says

    JOHANNESBURG, Nov 21 (Reuters) – A G20 draft leaders’ declaration includes references to “climate change” in defiance of U.S. objections, a source familiar with the matter said on Friday.

    The draft declaration was agreed ahead of this weekend’s summit in Johannesburg without U.S. input.

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    U.S. President Donald Trump recently called climate change a “con job”, and has not sent a delegation to the COP30 climate summit in Brazil.

    Reporting by Julia Payne; Editing by Aidan Lewis

    Our Standards: The Thomson Reuters Trust Principles., opens new tab

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  • Brazil’s agricultural research agency gets cannabis research greenlight

    Brazil’s agricultural research agency gets cannabis research greenlight

    SAO PAULO, Nov 21 (Reuters) – Brazilian agricultural research agency Embrapa has received the greenlight from health agency Anvisa to research the cannabis plant, a landmark move that puts farming powerhouse Brazil a step closer towards authorizing its cultivation.

    In an interview on Friday, Embrapa researcher Daniela Bittencourt welcomed Anvisa’s decision this week, which gives the agency unprecedented permission to build its first-ever cannabis seed bank and develop projects to genetically improve the plant for various applications.

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    Embrapa will also research hemp used to produce fibers, Bittencourt said.

    “This is only the beginning,” Bittencourt said by telephone from Brasilia. “Our plan is to carry out research for 12 years but it may possibly go on forever, like what happens with soy and corn.”

    Similar research efforts from Embrapa since the 1970s opened up vast regions of Brazil for large-scale soybean farming, kicking off a significant increase in the country’s output of the oilseed to make it the world’s largest producer and exporter.

    Embrapa scientists, who breed genetic varieties of grains, cotton and vegetables best suited for Brazil’s tropical climate, applied in September of 2024 for authorization from health agency Anvisa to carry out cannabis research.
    Embrapa’s work may also grab international attention from cannabis companies, which have shown interest in Brazil’s potential for the development and domestic sale of medicinal and industrial cannabis products for a long time.

    An initial 13 million reais ($2.41 million) in public funding will imminently be released to fund Embrapa’s cannabis research, Bittencourt said, adding the agency is open to studying the plant in partnership with the private sector.

    Despite recent delays, Bittencourt also said she is confident that by March 2026, Anvisa will issue pending regulation for cannabis cultivation in Brazil after a court ruling obliged it to do so in November 2024.
    In 2019, Anvisa had approved regulations for the rollout of medicinal cannabis products but in a separate vote blocked a proposal to allow domestic medical marijuana plantations.

    In the decision authorizing Embrapa’s cannabis research, Anvisa said it is developing rules for growing cannabis “for medicinal and scientific purposes.”

    Planting and selling recreational marijuana remains prohibited in Brazil, though purchasing and possessing up to 40 grams of marijuana for personal use is no longer a crime.

    ($1 = 5.3926 reais)

    (This story has been corrected to say that Embrapa applied for authorization to conduct cannabis research in September 2024, not February 2024, in paragraph 6)

    Reporting by Ana Mano; Editing by Richard Chang

    Our Standards: The Thomson Reuters Trust Principles., opens new tab

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  • US data agency cancels October inflation report as Fed considers whether to cut rates | Inflation

    US data agency cancels October inflation report as Fed considers whether to cut rates | Inflation

    The US federal government will not publish official data on inflation for October, depriving policymakers at the Federal Reserve of key information as they consider whether to cut interest rates.

    The Bureau of Labor Statistics canceled the release of the closely watched consumer price index (CPI) for October, citing the government shutdown – the longest in history, before it ended earlier this month – and stating it could not “retroactively collect” the data required for the report.

    The decision, announced on Friday, heightens uncertainty around the strength of the US economy. Jerome Powell, the Fed chair, had already likened the central bank’s task of guiding the economy, without standard data on its performance, to “driving in the fog”.

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    Price growth remains above typical levels, according to recent CPI releases. Donald Trump, who for months denied inflation was still high, has in recent weeks taken several steps to tackle concerns around affordability.

    Fed officials, under pressure from persistent demands from Trump, are meanwhile weighing whether to cut interest rates. The central bank raised rates aggressively in 2022 and 2023 to combat inflation, and started cautiously cutting them late last year.

    Powell has made clear he planned to trade carefully in the absence of important information on the economy’s strength, and direction. “We’re going to collect every scrap of data we can find, evaluate itand think carefully about it,” he said last month. “What do you do if you’re driving in the fog? You slow down.”

    That said, a speech by one Fed policymaker lifted expectations of another rate cut in December. John Williams, the president of the Federal Reserve Bank of New York, said on Friday that he still saw “room for a further adjustment in the near term” to rates.

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    The latest jobs report, for September, was a mixed bag, with 119,000 jobs added, but the unemployment rate ticked up to its highest level since 2021, and growth estimates for the preceding months were revised lower.

    The September jobs report was also disrupted by the shutdown, and released more than a month later. The complete October report will not be released at all, although data on the number of jobs created or lost in that month will be published alongside the full report for November – a week after the next Fed meeting.

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  • China's largest US soybean buy in 2 years buoys prices, triggers sales by struggling farmers – Reuters

    1. China’s largest US soybean buy in 2 years buoys prices, triggers sales by struggling farmers  Reuters
    2. Chicago soybeans slip  Business Recorder
    3. US soybean shipments to China sit idle despite Beijing’s pledge to buy big  Nikkei Asia
    4. USDA confirms more soybean exports to China and first wheat sale  UkrAgroConsult
    5. GLOBALink | China “very important to us”: CEO of U.S. Soybean Export Council_InKunming  昆明信息港

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  • BBC board member quits after being ‘cut out’ of talks over liberal bias claims | BBC

    BBC board member quits after being ‘cut out’ of talks over liberal bias claims | BBC

    A member of the BBC’s board has resigned after stating he was cut out of the discussions that led up to the shock resignation of its director general, Tim Davie.

    Shumeet Banerji, a tech industry executive, was away in the crucial days before the departure of Davie and the head of BBC News, Deborah Turness.

    The pair quit after tense board discussions over how to respond to allegations of liberal bias made by Michael Prescott, a former independent external adviser to the BBC’s editorial guidelines and standards committee. Prescott left that role in the summer.

    More details soon …

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