Clene (NASDAQ:CLNN) rises 5.2% after the company's disclosure on Sept. 8 that former director Chidozie Ugwumba now owns ~19.9%
https://seekingalpha.com/news/4010625-clene-rises-52-after-former-director-ugwumba-owns-199
Data released on Monday by AstraZeneca from a late-stage trial combining its blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer raises the bar for Johnson & Johnson's rival treatment, analysts said.
A brief summary from the Phase 3 trial, called FLAURA2, was released in May, and the detailed data was presented on Monday in Singapore at the World Conference on Lung Cancer.
The FLAURA2 trial showed that when adding chemotherapy to Tagrisso, the risk of disease progression or death is reduced by 38% when compared to Tagrisso alone.
The median progression-free survival (PFS) was 29.4 months, a 9.5 month improvement over patients given only Tagrisso. The term PFS refers to how long a patient lives without the disease getting worse after treatment.
Barclays and UBS said in separate notes that the strong results were a boost for the British drugmaker ahead of Johnson & Johnson's results due later this year of a head-to-head trial comparing Tagrisso alone with its own drug, Rybrevant, in combination with another medicine. That trial is called MARIPOSA.
"With the strong FLAURA-2 data in hand and likely included in treatment guidelines soon, the hurdle is now pretty high in our view for MARIPOSA," the UBS note read.
It called the data "a bit of a clearing event" that reduces risk for AstraZeneca given that analysts see Tagrisso as an important near- and medium-term driver of growth. The drug generated $5.4 billion in sales last year.
However, AstraZeneca shares were down 3.3% at 1128 GMT, with two analysts citing to Reuters a report in the Mail on Sunday newspaper saying the drugmaker's Chief Executive Pascal Soriot had said privately to friends and advisers that he may leave the company as soon as next year.
Reuters could not independently verify the information.
AstraZeneca declined to comment on the report.
In April, shortly before the company's new chairman Michel Demare took up that role, Soriot said he looked forward to working with him "in the years to come".
The family of a man who died by suicide is seeking a warning label on the ‘miracle’ weight loss drug Ozempic, claiming it contributed to his death, NBC News reported.
The family believes the man’s mood changes were linked to his use of Type 2 diabetes medicine.
The man, identified only as Anthony for privacy reasons, started taking Ozempic in February. By May, his family noticed a change in his usually outgoing personality, claiming he appeared fatigued and sullen. Anthony died by suicide in his Indiana home on May 14.
While Anthony had a history of depression, his family was shocked by his death and attributed it to his use of Ozempic.
“I think the Ozempic was putting these suicidal thoughts in his mind,” said Anthony’s sister.
While Ozempic and Wegovy have seen a surge in popularity, with a few patients reporting suicidal thoughts, believed to be a side effect. The European Medicines Agency and the U.K.’s Medicines and Healthcare Products Regulatory Agency are reviewing similar cases.
As of June 30, the U.S. Food and Drug Administration’s adverse event reporting system had received 59 reports of suicidal ideation, six reports of suicide attempts, and four reports of suicide-related to Ozempic. However, these numbers are self-reported and have not been verified.
Despite the family’s claims and the ongoing reviews, clinical trials did not find an association between Ozempic and suicidal thoughts. The FDA and the drug’s manufacturer, Novo Nordisk
said they are monitoring the safety of the drug and will take appropriate actions if a new safety signal for suicidal ideation/behavior is identified.
Novartis is discontinuing the development of GT005, a mid-stage investigational gene therapy being developed for geographic atrophy secondary to dry age-related macular degeneration.
The announcement was made Monday by Syncona Investment Management Limited, founder and former majority investor in Gyroscope Therapeutics, which originally developed GT005. Novartis acquired Gyroscope in December 2021 for $800 million upfront with the potential of up to $700 million in milestone payments.
“We are naturally disappointed for patients following the decision to discontinue GT005, but we respect Novartis’ decision,” Syncona CEO Chris Hollowood said in a statement, adding that the firm will continue to build and maintain its portfolio of companies to drive strong value for its shareholders and “make a difference to the lives of patients with devastating diseases.”
According to Syncona’s announcement, Novartis made the cut after an Independent Data Monitoring Committee reviewed available data from the lead Phase II HORIZON study and deemed that GT005’s performance “did not support continuation of the development program.”
As a result of GT005’s discontinuation, Syncona will write off approximately $62 million in milestone payments from Gyroscope that it would have received as part of the 2021 acquisition agreement.
Novartis’ decision to discontinue the development of GT005 in geographic atrophy (GA), an advanced form of age-related macular degeneration, comes two weeks after it similarly dropped the Xoma-partnered anti-TGFβ antibody NIS793. The candidate was being assessed as a potential first-line therapy for pancreatic ductal carcinoma, for which Novartis was running a Phase III trial that combined NIS793 with gemcitabine and nab-paclitaxel.
Though enrollment into all active clinical trials of NIS793 have stopped, Novartis will still collect data from these studies once they have concluded. Xoma will regain rights to NIS793, which will remain an investigational compound.
A month earlier, in July 2023, disappointing clinical data also caused Novartis to divest two other assets. The first was an anti-TIGIT checkpoint inhibitor being developed with BeiGene for non-small cell lung cancer. A week later, Novartis also abandoned the investigational obesity drug MBL949 after “lack of efficacy” in a Phase II trial.
MBL949 works via the GFD-15 pathway, which Novartis CEO Vas Narasimhan had previously touted as a “unique mechanism of action.”
In June 2023, Novartis also sold its dry eye disease drug Xiidra (lifitegrast ophthalmic solution) to Bauch + Lomb for $1.75 billion upfront, along with up to $750 million in potential milestones. Xiidra is the first FDA-approved prescription drug for dry eye disease and made $487 million in earnings in 2022.
by Savannah Fortis via CoinTelegraph.com,
Meta is reportedly in the process of building a new, more powerful and open-source AI model to challenge the most powerful systems of its rival OpenAI...
Meta, the parent company of social media platforms Facebook and Instagram, says it’s developing a new artificial intelligence (AI) model that will rival the most advanced model from OpenAI, according to a Wall Street Journal exclusive.
The Wall Street Journal reported that individuals familiar with the matter said Meta aims for the new AI model to be “several times” more powerful than its Llama 2 model, which it released earlier this year.
For the moment, The Wall Street Journal’s sources said that Meta’s plans for the new system are for it to be open-source and, therefore, allow other companies to build AI tools to produce high-level text, analysis and other types of output.
The company has also been building the data centers necessary to create such a high-level system while acquiring more of Nvidia’s H100 semiconductor chips, the most powerful and coveted chips currently available on the market.
Llama was trained on 70 billion parameters, and while OpenAI hasn’t released its parameters for GPT-4, they’re estimated to be around 1.5 trillion.
The sources said Meta anticipates training for the large language model (LLM) to begin in early 2024 and to be ready for release sometime next year. It is likely to be released after Google’s forthcoming LLM Gemini.
Microsoft is a primary backer of OpenAI and has also collaborated with Meta to help make Llama 2 available on Azure, its cloud computing platform. However, the sources said Meta plans to train its upcoming model on its own infrastructure.
This development comes as major tech companies and governments are racing to create, deploy and control high-level AI systems.
Recently, the United Kingdom government announced that it planned to spend $130 million on high-powered chips to create AI systems.
Across the globe, in China, the country’s new legislation on AI recently went into effect. Since then, the CEO of Baidu, a major China-based tech company, has said that over 70 AI models have been released in the country.
https://www.zerohedge.com/technology/meta-building-ai-model-rival-openais-most-powerful-system
by Mimi Nguyen Ly via The Epoch Times,
The U.S. government has confirmed that it seized nearly a million barrels of crude oil from Iran that was allegedly bound for China.
The Justice Department (DOJ) confirmed on Sept. 8 that in April, the United States seized a shipment of crude oil from the Islamic Revolutionary Guard Corps (IRGC), a designated foreign terrorist organization.
In confirming the confiscation, the department also announced its first criminal resolution involving the illicit sale and transport of Iranian oil, which is a violation of U.S. sanctions.
"This is the first-ever criminal resolution involving a company that violated sanctions by facilitating the illicit sale and transport of Iranian oil and comes in concert with a successful seizure of over 980,000 barrels of contraband crude oil," the announcement reads.
Unsealed court documents show that in April, the United States seized from the tanker Suez Rajan contraband cargo that was allegedly being sold by the IRGC to China.
On April 19, the vessel's owner, Suez Rajan Ltd., pleaded guilty to conspiring to violate the International Emergency Economic Powers Act (IEEPA) in smuggling the sanctioned Iranian crude oil. Under a plea agreement, the company agreed to pay a $2.4 million fine and face three years of corporate probation.
Greek shipper Empire Navigation, the operating company of the Suez Rajan, agreed to cooperate and transport the Iranian oil to the United States at its own expense, a task that has since been completed.
"The contraband cargo is now the subject of a civil forfeiture action in the U.S. District Court for the District of Columbia," the DOJ stated. "The United States’ forfeiture complaint alleges that the oil aboard the vessel is subject to forfeiture based on U.S. terrorism and money laundering statutes."
The U.S. Treasury has stated that Iran’s oil smuggling revenue supports the Quds Force, an elite unit within the IRGC that operates across the Middle East.
The complaint accuses several groups linked to Iran’s IRGC and the Quds Force of secretly selling and shipping Iranian oil to China.
The prosecution relied on satellite images, as well as documents, to allege that the Suez Rajan attempted to disguise its acquisition of Iranian crude oil from one tanker by falsely claiming that it received the oil from a different tanker.
They allegedly hid the oil's origin through methods including ship-to-ship transfers, as well as masking the locations and identities of the vessels involved via false reporting and false documents.
The complaint also alleged that the vessel's charterer used the U.S. financial system to facilitate the transportation of the oil.
The court documents allege that "profits from oil sales support the IRGC’s full range of malign activities, including the proliferation of weapons of mass destruction and their means of delivery, support for terrorism and both domestic and international human rights abuses," according to the DOJ.
For months, the tanker sat in the South China Sea near Singapore's northeast coast, before sailing for the Texas coast. The vessel transferred its cargo to another tanker, which released its oil in Houston in recent days.
At the time, U.S. authorities wouldn't confirm that they were seizing the cargo or that the vessel was en route to the United States. But the DOJ on Sept. 8 confirmed that the U.S. government had seized the oil.
Shortly after the Suez Rajan headed to the United States, Iran seized two tankers in late April—the Advantage Sweet, flying the Marshall Islands flag and heading toward the United States in the Gulf of Oman, and the Niovi, owned by Greece traveling to the United Arab Emirates's Fujairah from Dubai. In response, the U.S. Navy condemned Iran for its "continued harassment of vessels and interference with navigational rights in regional waters."
The U.S. military in early July stated that it stopped two more Iranian attempts to seize commercial tankers in the Gulf of Oman.
That same month, the top commander of the IRGC's naval arm threatened further action against anyone offloading the Suez Rajan with Iranian state media linking the recent seizures to the cargo’s fate.
Late on Sept. 6, the United States updated its warning to shippers traveling through the Middle East.
“Commercial vessels transiting through the Persian Gulf, Strait of Hormuz, and Gulf of Oman continue to be illegally boarded and detained or seized by Iranian forces,” the warning reads.
With the world's fourth-largest reserves of oil, Iran is highly dependent on oil revenue. But sanctions have restricted its ability to pump at anywhere near capacity since 2018.
This year, Iranian oil exports have mostly been above 1 million barrels per day despite U.S. sanctions, according to the commodity data firm Kpler. In May and June, it went above 1.5 million barrels per day, with figures in August sitting at 1.4 million barrels daily, Kpler's data show. China is believed to be a major buyer of Iranian oil, likely at a significant discount.
