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Thursday, December 5, 2024

Novo Nordisk to cut US list prices of two insulin products by more than 70%

 Novo Nordisk today announced plans to reduce the US list prices of two insulin products by more than 70% to better meet the needs of people living with diabetes.

The list prices of vials and pre-filled pens of insulin aspart (rapid-acting) and basal insulin (long-acting), specifically Tresiba® and Fiasp®, will be reduced in the US starting January 1, 2026. Those new list prices, also referred to as wholesale acquisition costs (WAC), will be:

Tresiba®U-100 VialU-100 DeviceU-200 Device
Current WAC/pkg$338.95$508.43$610.11
New WAC/pkg$94.29$141.43$169.71
 
Fiasp®VialFlexTouch®PenFill®PumpCart®
Current WAC/pkg$289.36$558.83$537.47$286.65
New WAC/pkg$72.34$139.71$134.37$71.66
 

The list prices of Fiasp® will be reduced by 75%, matching the price of NovoLog®. Additionally, the list prices of Tresiba® will be reduced by 72.2%, making it 20% lower than its unbranded biologic equivalent, insulin degludec, thereby rendering the latter redundant. As such, Novo Nordisk Pharma, Inc. will discontinue the unbranded biologic versions below by December 31, 2025.

  • Insulin Aspart 10 mL vial
  • Insulin Aspart 3 mL PenFill® cartridge
  • Insulin Aspart 3 mL FlexPen®
  • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 10 mL vial
  • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 3 mL FlexPen®
  • Insulin Degludec 100 units/mL (U-100) 10 mL vial
  • Insulin Degludec 100 units/mL (U-100) 3 mL FlexTouch®
  • Insulin Degludec 200 units/mL (U-200) 3 mL FlexTouch®

Novo Nordisk is making healthcare professionals, wholesalers and payers aware of the discontinuations more than 12 months in advance, so they can enable smooth transitions to other options. Patients should speak with their healthcare professional about their treatment options to determine the best course of action.

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915073

Lilly invests $3 billion to expand Wisconsin plant as obesity drug demand soars

 Eli Lilly LLY.N said on Thursday it will invest $3 billion to expand the manufacturing plant it bought in Pleasant Prairie, Wisconsin earlier this year, as it scrambles to meet soaring demand for its weight-loss and diabetes drugs.

The new investment in the factory, which it acquired from Nexus Pharmaceuticals, will help boost production of Lilly's powerful weight-loss drug Zepbound as well as its diabetes treatments and other medicines, the company said.

“Today's announcement represents our single largest U.S. manufacturing investment outside our home state of Indiana and will add to our ability to expand capacity to make both our existing and future pipeline of medicines,” said Edgardo Hernandez, Lilly's president of global manufacturing.

Zepbound and Lilly's diabetes drug Mounjaro, both known chemically as tirzepatide, were in shortage in the U.S. for much of this year. The U.S. Food and Drug Administration removed tirzepatide from its shortage list earlier this year but is reconsidering that decision following a lawsuit from an industry group representing compounding pharmacies that make and sell versions of the drug not approved by the FDA.

Zepbound was introduced in the U.S. in late 2023. More than 5.2 million prescriptions have since been written for the drug, according to data from IQVIA IQV.N shared by an analyst.

Lilly said it has committed a total of more than $23 billion to building, expanding and buying manufacturing sites since 2020. The acquisition, expansion, and additional purchases of land and the adjacent warehouse in Wisconsin bring Lilly’s total planned investment in the site to $4 billion, it said.

Lilly, which has become the world's most valuable healthcare company worth over $790 billion, said it plans to start construction on the expansion next year, and previously said it expects production at the facility to begin at the end of 2025.

The company said it expects to add 750 jobs to the Wisconsin plant, which already has more than 100, including operators, technicians, engineers and scientists.

Danish rival Novo Nordisk NOVOb.CO has also invested billions in manufacturing to ramp up supply of its popular weight-loss drug Wegovy, announcing it would take over three sites from contract manufacturer Catalent CTLT.N for $11 billion earlier this year.

https://www.xm.com/au/research/markets/allNews/reuters/lilly-invests-3-billion-to-expand-wisconsin-plant-as-obesity-drug-demand-soars-53982613

Healthcare industry rethinks risk after murder of UnitedHealth exec

 -Health insurance companies are reassessing the risks for their top executives after the murder of UnitedHealthcare CEO Brian Thompson on Wednesday in Manhattan, with both UnitedHealth and rival CVS Health CVS.N removing photos of their leadership teams from their websites after the shooting.

UnitedHealthcare, part of UnitedHealth Group UNH.N, is the biggest U.S. insurer. CVS operates Aetna, another top insurer.

Thompson was killed in an attack police called targeted as he was about to enter the Hilton hotel for the company's annual investor conference. The gunman, whose crime was recorded on video, is at large and the New York City Police Department said there was no known motive for the murder.

Robert D’Amico, founder of Sierra One Consulting, who previously worked with the FBI, said the removal of photos showed, "These companies are hearing what experts like me have been saying about how easy it is to identify and then find their executives."

UnitedHealth took down Thompson's and other executives' photos from its website on Wednesday. A spokesperson did not respond to a query asking what the motivation was. CVS removed pictures of all its top executives on Thursday. The company declined to comment.

D'Amico and a second security expert, who said they are constantly assessing risk for top executives based on news events or the business their companies conduct, expect companies to ramp up physical security for executives.

The healthcare sector in the last 18 months has explored new security measures as they encountered increasing conflict and the potential for violent crime, said Glen Kucera, president of Enhanced Protection Services at security firm Allied Universal.

Before the shooting, most risk assessment efforts were conducted for medical practices and other healthcare providers, which have faced increasing hostility from the public since the COVID-19 pandemic.

Rising demand for protection in hospitals and healthcare facilities is in line with most customer-facing industries, said Garett Seivold, chief content and communications officer at the International Security Ligue.

Assessing risk involves searching social media and trying to determine whether threats have been made, circumstances which have not been made public regarding Thompson, Kucera said.

Thompson's wife, Paulette, told NBC News on Wednesday that he had been receiving some threats related to his job and "coverage" but said she did not know the details. A spokesperson for UnitedHealthcare did not have an immediate comment on possible threats against Thompson.

"I think there's going to be a lot of executives that are going to say, 'Hey, you know, this could happen to me and we should really consider our security protocol going forward,'" Kucera said.

D’Amico said he expects corporate boards of directors to reassess their security plans for executives.

That would include asking for assessments on how big a security detail to deploy while weighing the cost. Someone like billionaire Elon Musk has 20 people around them every day, he said.

He pointed to angry social media posts which appeared to show people verbally attacking health insurance companies and employees in the immediate aftermath of Thompson's murder.

"I think the healthcare companies are going to see that and realize that there's more hate out there for them and their executives," D'Amico said.

Consumer frustration with health insurance in the U.S. has been high for years and led to the 2010 Affordable Care Act, popularly known as Obamacare. This year, insurance companies have struggled to hold down costs and have talked about their increased use of medical management, which includes making it more difficult to quickly receive coverage for services like surgery or medicines.

It is not known whether Thompson's job played any role in his death, but the shooting has brought attention to increasing tension with the healthcare industry.

Cigna CI.N, Elevance ELV.N, Centene CNC.N and Molina MOH.N did not respond to requests for comment about whether they were making any security changes now or had done so.

Health insurers do not provide details on their spending on security for executives in financial regulatory filings.

https://www.xm.com/au/research/markets/allNews/reuters/healthcare-industry-rethinks-risk-after-murder-of-unitedhealth-exec-53982611

Ukraine Firmly Rejects US Calls to Lower Conscription Age To 18

 Ukraine has firmly rejected calls from Washington and NATO leadership to lower its age of conscription from 25 to 18, amid widespread acknowledgement that it doesn't have enough able-bodied fighting men to defend the front lines or slow the Russian military advance.

President Zelensky's office responded to White House urgings to get "younger people" into the fight by saying there are not enough weapons to begin with, so forcing more young men into the military will make little difference.

Volunteers: Maksym Lutsyk,19 (left) and Dmytro Kisilenko, 18. Via BBC

Zelensky’s communications adviser, Dmytro Lytvyn, issued a statement Wednesday night, directly addressing the controversy which is currently in international headlines, also after NATO Secretary-General Mark Rutte piled on the pressure from Brussels. 

He started by explaining that the real problem Ukraine's military faces is delayed weapons transfers from Western partners. He asserted that Kyiv "lacks weapons to equip already mobilized soldiers."

"It doesn’t make sense to see calls for Ukraine to lower the mobilization age, presumably in order to draft more people, when we can see that previously announced equipment is not arriving on time. Because of these delays, Ukraine lacks weapons to equip already mobilized soldiers," Lytvyn said on X.

He claimed further that the Western allies "have complete access to the data and can compare promises to actual deliveries" - again putting the blame on Ukraine's foreign supporters.

"Ukraine cannot be expected to compensate for delays in logistics or hesitation in support with the youth of our men on the frontline," he added.

Earlier, US Secretary of State Antony Blinken urged the Zelensky government to make "hard decisions" about expanding mobilization efforts to fight the Russians. 

"Getting younger people into the fight, we think, many of us think, is necessary" Blinken stated in a NATO press conference on Wednesday. "Right now, 18- to 25-year-olds are not in the fight," he explained.

He emphasized that that manpower is critical "because even with the money, even with the munitions, there have to be people on the front lines." The Biden White House has been rushing as much arms to Ukraine forces as it can with little time left in the Democratic administration. Blinken also stressed that NATO is seeking to ensure every soldier Ukraine mobilizes has "the training and the equipment they need to effectively defend the country."

Zelensky's rejection of lowering conscription age is probably a strong indicator that negotiations are just around the corner. Also, if he moved to suddenly change the current policy, he could face rebellion among Ukrainians who don't want to prolong the war, and who worry about their family members dying in the Donbas.

https://www.zerohedge.com/markets/ukraine-firmly-rejects-us-calls-lower-conscription-age-18

FDA chief defends work on obesity, food to US Senate as agency awaits fierce critic RFK Jr

U.S. Food and Drug Administration Commissioner Robert Califf defended the agency's role in addressing the country's obesity epidemic as he was grilled by senators over FDA regulation of the food and beverage industry on Thursday.

The hearing of the Senate Committee on Health, Education, Labor and Pensions follows President-elect Donald Trump's selection of Robert F. Kennedy Jr, to lead the Department of Health and Human Services, the country's top health agency. Kennedy, a vaccine skeptic, has also said those at the agency in charge of nutrition labels on food have "to go". 

Kennedy has criticized popular weight-loss drugs such as Novo Nordisk's Wegovy and called for removing ultra-processed foods from school lunches as part of a goal to reduce the incidence of diet-related chronic diseases.

"We have just completed the largest reorganization in FDA's history, in no small part, so that we could take on the issues of nutrition and chemicals in our food supply," Califf said during testimony to the Senate committee led by Bernie Sanders.

Sanders and other senators questioned agency officials over several regulations related to the food and beverage industry, including a delayed proposal to require nutrition labels on the front of products.

"According to the CDC, the rate of childhood obesity in America has tripled since the 1970s, and from where I'm standing here the FDA has not responded in any way with the urgency of the crisis. How long does it take to put a bloody label on a product?" Sanders said. 

Califf said the agency was trying to do its part within its authority and budget.

"As you know, I'll be leaving FDA (with) the change of administrations, but I can assure you that our people at FDA want to do more, and we need your partnership," he said.

Califf, a cardiologist and researcher, has held the role of FDA commissioner for a second time since 2022. He previously led the world's most influential health regulator during the Obama administration between 2016 and 2017.

Trump has nominated surgeon and author Martin Makary to succeed Califf as FDA Commissioner.

Califf said the research around popular new weight-loss drugs had helped understanding of the addictive nature of some of the foods that Americans consumed. Unlike with drugs, he emphasized that the agency did not have insight into research done by the food industry. 

Lawmakers grilled Califf, and FDA executive James Jones, who has been tasked with leading the agency's new human foods program, over the use of food dyes and criticized inadequate and complex labeling of plant-based and genetically-engineered products. 

Califf said the FDA had repeatedly asked for better funding for chemical safety, calling it a huge priority. He added that the agency was also trying to recruit more employees for food manufacturing site inspections, but said it did not always have the resources to do so. 

https://www.usnews.com/news/top-news/articles/2024-12-05/fda-chief-defends-work-on-obesity-food-to-us-senate-as-agency-awaits-fierce-critic-rfk-jr

Mexico seeks Trump agreement to avoid receiving non-Mexican deportees

 Mexico is seeking an agreement with U.S. President-elect Donald Trump to ensure Mexico does not receive deportees from third countries in case of large-scale deportations from the United States, President Claudia Sheinbaum said on Thursday.

Trump has promised a vast crackdown on immigrants living illegally in the United States, and his running mate JD Vance has floated deporting 1 million people a year.

Mexico has played a key role in implementing U.S. immigration policy in recent years, accepting migrants from countries to which the U.S. struggles to deport people, such as Cuba, Haiti, Nicaragua, and Venezuela.

The Trump transition team has discussed deporting migrants to places other than their home country if those nations will not accept them, two sources familiar with the matter told Reuters.

The possible destinations could include Panama, Turks and Caicos, the Bahamas, and Grenada, one of the sources said, confirming an NBC News report.

The Bahamas said in a statement on Thursday it had received such a request but that it had been "reviewed and firmly rejected."

The governments of Turks and Caicos, Panama and Grenada did not immediately respond to requests for comment.

In late October, Trump's border czar Tom Homan told Reuters that sending migrants to other countries, including Mexico, would be an option.

The Trump transition did not immediately respond to a request for comment.

Sheinbaum did not say outright that Mexico would refuse migrants from other countries but did say her government would look to avoid it.

"We hope to reach an agreement with the Trump administration so that, in case these (mass) deportations happen, they send people from other countries directly to their countries of origin," Sheinbaum told a press conference.

The president said Mexico was "in solidarity with everyone, but our main purpose is to receive Mexicans."

U.S. government estimates suggest nearly half of immigrants living in the U.S. illegally are Mexican.

Mexican officials are bracing for the arrival of large numbers of Mexicans deported from the U.S. once Trump takes office in January though Sheinbaum has argued the deportations are unnecessary, pointing to the contribution made by Mexican migrants to the U.S. economy.

Mexican Foreign Minister Juan Ramon de la Fuente is currently in the United States. He is set to tour an Immigration and Customs Enforcement processing center "to see firsthand the processes which should guarantee conditions and respect for the human rights of Mexicans being returned," the foreign ministry said.

https://www.yahoo.com/news/mexico-does-not-want-us-150616830.html

7.0 magnitude earthquake hits Northern California, tsunami warning

A preliminary magnitude 7.0 earthquake hit some 60 miles off Ferndale in Humboldt County late Thursday morning, according to the United States Geological Survey. In the aftermath of the shaking, the National Weather Service issued a tsunami warning, urging Californians to "get away from coastal waters." The timing for the tsunami impacts are as follows:


Fort Bragg: 11:10 a.m.  

Crescent City: 11:20 a.m.

San Francisco: 12:10 p.m.

The earthquake struck at a depth of about 10 kilometers at approximately 10:44 a.m. No damage or injuries were immediately reported, the USGS said. BART has stopped all trains from using the Transbay Tube for the time being.


https://www.sfgate.com/bayarea/article/earthquake-hits-northern-californi-tsunami-warning-19962096.php