Novo asks FDA to restrict Victoza compounding amid GLP-1 outsourcing row

 As concerns around knockoffs of newer GLP-1 drugs like Ozempic and Wegovy take center stage, Novo Nordisk’s efforts to ward off competition against its aging diabetes blockbuster Victoza have been quietly simmering in the background.

In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster.

Apart from Victoza, which was approved for Type 2 diabetes in 2010, liraglutide also underpins Novo’s older weight loss drug Saxenda and its insulin-degludec-based diabetes combination therapy Xultophy.

While a newer class of GLP-1s based on Novo’s semaglutide has redefined the Danish drugmaker’s business in recent years, Victoza remained one of the company’s top earning drugs in 2023, when it brought home (PDF) sales of nearly 8.67 billion Danish kroner (around $1.2 billion).

Meanwhile, generic drug makers have already sought out to capitalize on liraglutide’s success. Teva launched an authorized generic for Victoza in the U.S. in June, while Hikma has already rolled out its own copycat following an FDA approval that came through shortly after Christmas.

Complicating the issue for Novo, generic drug makers and compounders, however, is the fact that certain doses of Victoza and Saxenda are currently listed on the FDA’s online drug shortage database, presenting a potential opportunity for outsourcers to make their own versions of the drug.

To hear Novo tell it, the outsourcing group OFA shouldn’t be allowed to place liraglutide on its compounding list given that FDA-approved generics to Victoza are available. Further, the OFA has failed to “establish a clinical need” to compound drugs using liraglutide, Novo’s lawyers argued in the petition.

Novo additionally argued that producing liraglutide is tricky and that “even small changes in the manufacturing process … can substantially affect its chemical and physical stability, as well as its impurity profile.”

Novo has made similar claims about the challenges of Victoza manufacturing in the past.

Back in 2017, the drugmaker filed a separate citizen petition arguing that the production process for the GLP-1 was so complex that any generic hopefuls should need to prove their equivalence via clinical trials.

More recently, Novo has largely shifted its attention toward knockoff versions of its newer GLP-1 meds, Ozempic for Type 2 diabetes and Wegovy for obesity, both of which are girded by the molecule semaglutide.

In October, Novo asked the FDA to prevent compounders from producing copycats of Ozempic and Wegovy, again making the argument that the treatments are too complex to replicate safely.

Novo specifically requested semaglutide be added to the FDA’s Demonstrable Difficulties for Compounding lists, citing complexities around formulations, delivery mechanisms, dosage forms, bioavailability and more.

Meanwhile, Novo’s chief rival in the metabolic medicine space, Eli Lilly, adopted a similar tack this week when it filed a motion to intervene in a lawsuit brought by the OFA—the same compounding organization at the center of Novo’s petition—attempting to sway the FDA to reverse its decision to declare the shortage of Lilly’s dual GIP/GLP-1 agonist tirzepatide resolved.

Lilly posed similar arguments to Novo’s, contending in a legal filing this week that compounded versions of tirzepatide—which is marketed under the brand names Mounjaro and Zepbound—aren’t beholden to the same safety and quality standards as the Lilly products they reference.

Beyond this week’s legal filings, both Novo and Lilly have been waging a broader legal campaign against health spas, clinics and pharmacies in a bid to corral imitations of their highly-profitable incretin drugs. 

https://www.fiercepharma.com/pharma/novo-asks-fda-put-kibosh-victoza-compounding-amid-glp-1-outsourcing-row

Former German FinMin Says Corruption In Ukraine "Rampant", Most Ukrainians Agree

 Via Remix News,

“Ukraine is now ruled by an oligarch who increasingly relies on foreign aid. A state where corruption is rampant and there are no real democratic structures,” former German Finance Minister Oskar Lafontaine told the Frankfurter Allgemeine Zeitung, cited by news agency V4NA.

The former minister emphasized that independent parties and mass media are banned in Ukraine and establishing democracy and independence would take a long time.

Reports of corruption are common in Ukraine, especially in the military, according to Magyar Nemzet. A recent anti-corruption investigation identified 30 Ukrainian officials suspected of embezzling funds, including employees of housing and maintenance departments, as well as representatives of commercial structures across Ukraine. Prosecutors say 15 of them were members of organized crime groups.

And as Zelensky goes begging for more money from President Joe Biden for the war, Ukraine’s Prosecutor General’s Office announced last week that it has uncovered a large-scale scheme to embezzle more than $3.7 million from the state budget — funds that had been meant for the Ukrainian Armed Forces to finance everything from heating and electricity to military infrastructure construction work. 

Prosecutors say some of these goods were purchased at significantly higher prices than market prices. Some of the suspects are also accused of abuse of power and negligence in military service. One of the defendants, the head of a regional housing and maintenance department, is suspected of illegally purchasing $285,000 worth of commercial equipment, land and other valuables that were registered in the name of an intermediary. 

Magyar Nemzet lists several scandals, including in January 2023 when Deputy Defense Minister Vitaly Polovenko announced that the Ukrainian Defense Ministry had terminated contracts with companies owned by Lviv businessman Ihor Hrynkevich, who was involved in the scandalous procurement of clothing for the armed forces. That same month, the Security Service of Ukraine announced that it had detained a colonel of the Ukrainian Armed Forces and the CEO of a defense supply company on suspicion of corruption.

In Ukraine, high-level corruption ranks second among the main concerns of Ukrainians after the Russian-Ukrainian war, a survey conducted by the National Agency for the Prevention of Corruption revealed. The results of the research previously presented by the Transcarpathian news portal Kárpáti Igaz Szó show that 71.6 percent of the population consider this to be the country’s second-biggest problem, and 73 percent of entrepreneurs think the same.

According to 87.9 percent of the population and 81.3 percent of businesses, the level of embezzlement in the country has increased compared to 2022. Many hold Zelensky responsible, with 47.5 percent of citizens and 48.3 percent of company representatives stating that combating corruption is the responsibility of the president and his office.

In contrast, 36.9 percent of respondents and 32.4 percent of business people say that the anti-corruption agency, or the Supreme Council, is the one that should take action to curb corruption. The responses also included claims that the Council of Ministers and ministries can be held accountable for the spread of corruption.

Corruption in Ukraine has been getting much coverage lately. One widely followed account on X called out the additional billions U.S. President Biden is sending to Ukraine, to which one commenter stated: “Zelensky has genuinely pulled off one of the greatest money heists of all time,” with X owner Elon Musk pitching in, calling Zelensky “All-time champ.”

https://www.zerohedge.com/geopolitical/former-german-finmin-admits-corruption-ukraine-rampant-and-large-majority-ukrainians

US national security adviser Sullivan to discuss Chinese dams in India visit

 U.S. national security adviser Jake Sullivan's visit to New Delhi from Jan. 5-6 is expected to include discussions with Indian counterparts about the impact of Chinese dams, a senior U.S. official said late on Friday.

Washington and its Western allies have long viewed India as a counter to China's rising influence in Asia and beyond.

"We've certainly seen in many places in the Indo-Pacific that upstream dams that the Chinese have created, including in the Mekong region, can have really potentially damaging environmental but also climate impacts on downstream countries," a senior U.S. official said ahead of Sullivan's visit.

The official added that Washington will discuss New Delhi's concerns in the visit.

The Indian government says it has conveyed its concerns to Beijing about China's plan to build a hydropower dam in Tibet on the Yarlung Zangbo River which flows into India. Chinese officials say that hydropower projects in Tibet will not have a major impact on the environment or on downstream water supplies.

The construction of that dam, which will be the largest of its kind in the world with an estimated capacity of 300 billion kilowatt-hours of electricity annually, was approved last month.

Washington also expects that topics such as civilian nuclear cooperation, artificial intelligence, space, military licensing and Chinese economic overcapacity will be brought up in the visit, the U.S. official said.

American officials will not be meeting the Dalai Lama during the visit, another U.S. official said.

Washington and New Delhi have built close ties in recent years with occasional differences over issues like minority abuse in India, New Delhi's ties with Russia amid Moscow's invasion of Ukraine and alleged assassination plots against Sikh separatists on U.S. and Canadian soil.

https://www.yahoo.com/news/chinese-dams-discussed-during-india-221715125.html

Central American troops arrive in Haiti to fight gangs

A contingent of security forces from Guatemala and El Salvador arrived in Haiti's capital on Friday to reinforce a long-delayed United Nations-backed mission tasked with restoring security amid a bloody conflict with armed gangs.

The new arrivals were made up of 75 Guatemalans and eight Salvadorans, a communications officer for the mission said.

The president of Haiti's transitional presidential council, Leslie Voltaire, alongside Prime Minister Alix Didier Fils-Aime and U.S. Ambassador Dennis Hankins, welcomed the troops at Port-au-Prince's airport, Haiti's interim government said in a post on social media.

"They have come to reinforce the Multinational Force in the fight against gangsters and guns in the country," the government said.

Guatemalan President Bernardo Arevalo had in September pledged to send 150 military police, three months after initially pledging in a letter to the U.N. an unnumbered contingent alongside personal equipment.

El Salvador had in August promised 78 soldiers for medical evacuation operations as well as three helicopters - much needed by Haitian security forces contending with mountainous terrain and highways scattered with gang-controlled checkpoints.

Salvadoran President Nayib Bukele, who has garnered broad popularity over a harsh crackdown on organized crime in his home country including the use of mass trials and construction of a "mega-jail", has stated that he would be able to "fix" Haiti and that its gangs must be "obliterated."

The mission is being led by Kenya, which deployed nearly 400 police in the middle of last year, far short of the 1,000 it had promised. The police were later joined by 24 Jamaican personnel and two senior officers from Belize.

However, the mission has failed to prevent gangs from taking new territories and committing several massacres as violence dramatically escalated in the last months of 2024, causing thousands more people to flee their homes.

Haiti's national police have meanwhile shed thousands of officers in recent years.

Some 10 countries have together pledged over 3,100 troops for Haiti, but few have so far deployed.

https://www.yahoo.com/news/central-american-troops-arrive-haiti-205953984.html

Microsoft plans to invest $80 billion on AI-enabled data centers in fiscal 2025

 Microsoft (MSFT) is planning to spend tens of billions of dollars to build on its artificial intelligence ambitions this year.

The tech giant is on track to invest $80 billion in AI-enabled data centers in fiscal year 2025, which ends on June 30, Microsoft President Brad Smith said in a blog post on Friday. The data centers will be used for training and deploying AI models and cloud-based applications. More than half of the investment will be focused in the U.S., Smith added.

“As we look into the future, it’s clear that artificial intelligence is poised to become a world-changing GPT [General-Purpose Technology],” Smith said. “AI promises to drive innovation and boost productivity in every sector of the economy. The United States is poised to stand at the forefront of this new technology wave, especially if it doubles down on its strengths and effectively partners internationally.”

The U.S. is the leader in “the global AI race” due to private capital investments and innovation by U.S.-based companies, Smith said, noting Microsoft’s partnerships with ChatGPT maker OpenAI and the startup’s rivals, Anthropic and xAI.

Under the incoming Trump administration, Smith said the U.S. can “build on the foundational ideas set for AI policy” under the president-elect’s first term, including the 2019 executive order on maintaining the U.S.’s AI leadership. He added that “America’s technology success” requires a partnership between the government, the private sector, and educational and non-profit institutions.

In October, Microsoft chief executive Satya Nadella said on the company’s post-earnings call that the tech giant had run into external constraints due to high demand for AI training and inferencing. Data center constraints left investors unimpressed by Microsoft’s first fiscal quarter results, sending its shares down by over 5%.

“[Data centers] don’t get built overnight,” Nadella said. “Even in Q2 for example, some of the demand issues we have, or rather our ability to fulfill demand is because of, in fact, external third-party stuff that we leased moving up. That’s the constraints we have.”

However, Nadella said he felt “pretty good” going into the second half of the fiscal year that some supply would catch up with demand.

https://finance.yahoo.com/news/microsoft-plans-spend-80-billion-204000107.html

Wells Fargo says 'dominant pick' Citi's stock could double in three years

 Citigroup's stock could double in value over the next three years as profits surge, expenses moderate, and the "most significant" reorganization in five decades improves management accountability, Wells Fargo analysts wrote in a note on Friday.

The third-largest U.S. lender is the brokerage's "dominant pick" among large-cap banks under almost any scenario, barring a recession. The analysts raised their price target to $110 from $95, while maintaining an "overweight" rating.

Citi's shares rose as much as 1.6% to $71.09.

The vote of confidence marks a notable win for Citi CEO Jane Fraser, who has been looking to improve the bank's profitability since taking the helm in 2021.

Wells Fargo's Mike Mayo, known for his blunt critique of the banking industry's missteps, praised Fraser's sweeping overhaul in 2024 to cut costs and simplify the bank's sprawling businesses.

"Investors seem to underappreciate... the improved management accountability after transition from 50 years of a global matrix structure to 5 lines of business," the Citi bull said.

Analysts had described 2024 as a transitional year for the bank and said the reshuffle represents an inflection point that will increase efficiency.

Separately, KBW analysts led by David Konrad also raised their price target on Citi to $85 from $82, calling it one of their "top ideas" for 2025.

Increased capital markets activity and Citi's discounted valuation compared to peers could present a compelling opportunity, it said.

Citi trades at a price-to-book ratio, a common benchmark for valuing stocks, of 0.69, according to data from LSEG. This compares with JPMorgan Chase's 2.08 and Bank of America's 1.25.

A ratio below one typically indicates an undervalued stock.

The bank is expected to report results in mid-January, with all eyes on executive commentary on growing key businesses in 2025.

"The significance of Citi inflecting from multi-year value destruction to value creation is in our view one of the greatest drivers for sustainable stock price outperformance," said Mayo.

https://finance.yahoo.com/news/wells-fargo-names-citi-dominant-155141058.html