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Wednesday, March 6, 2024

Escalating Demand for Obesity Drugs Creates Time-Sensitive Race for Lilly, Novo Nordisk

 Eli Lilly 

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 is aggressively pursuing collaborations with outsourcing partners to ramp up the production of its obesity drug, Zepbound (tirzepatide), as it inks deals with key players such as National Resilience and BSP Pharmaceuticals for the filling and “finishing” of its injector pens.

BSP Pharmaceuticals and National Resilience are among the specialized contract manufacturers capitalizing on the obesity drug boom. 

The global contract development and manufacturing market is poised to grow from $72 billion to $90 billion in the next two years, highlighting the urgency for increased fill-finish capacity.

Eli Lilly and Novo Nordisk A/S 

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 have invested billions to address bottlenecks in active ingredient production and fill-finish as the companies grapple with a shortage of the most sought-after drugs for diabetes and weight loss.

Despite Novo Nordisk’s recent acquisition of three “fill-finish” plants from Catalent Inc 

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, the company will not be able to scale up production until 2026, the Financial Times noted.

National Resilience, a recipient of a $410 million loan from the U.S. defense department, aims to fill Zepbound injector pens at its Cincinnati plant, with a total capacity of 200 million doses by 2025. 

Meanwhile, the Financial Times noted that BSP is gearing up to produce 61 million injectable doses of non-cancer drugs by the end of next year.

As Eli Lilly accelerates production through external collaborations, challenges in the fill-finish stage persist due to close-to-full production capacities. 

Citing industry experts, the Financial Times highlights that while oral weight-loss pills are under development by major players, supply constraints may persist for several years. 

The global contract drug manufacturer market, though expanding, may not provide an immediate solution to the escalating demand for obesity drugs, leaving Eli Lilly and Novo Nordisk in a race against time.

https://www.benzinga.com/general/biotech/24/03/37510490/escalating-demand-for-obesity-drugs-creates-time-sensitive-race-for-eli-lilly-novo-nordisk

"Dirty Voter Rolls, Dirty Elections": Illinois Sued To Clean Up "Mess"

 Illinois is being sued over its failure to clean up the state's voter rolls and produce election-related records as required under federal law.

Legal watchdog organization Judicial Watch announced on Wednesday that they want Illinois to "develop and implement a general program that makes a reasonable effort to remove the registrations of ineligible registrants from the voter rolls."

According to JW, the National Voter Registration Act requires states to "conduct a general program that makes a reasonable effort to remove" from the official voter rolls "the names of ineligible voters" who have either died or changed residence - and that registrations must be cancelled when voters fail to respond to address confirmation notices, followed by subsequent no-shows in the next two general elections.

Pas efforts by Judicial Watch have led to the removal of up to four million ineligible voters from rolls in New York, California, Pennsylvania, Colorado, North Carolina and several other states.

Judicial Watch points out:

  • Illinois’ own reported data show that more than one fifth of its counties removed few or no registrations under a crucial NVRA provision concerning voters who have moved.
  • Illinois informed the federal Election Assistance Commission (EAC) that 34 counties simply failed to report any data about removals under that key NVRA provision
  • Nineteen of these counties also failed to report any data regarding registrations removed because of the death of the voter.
  • Dozens of other counties failed to report other kinds of important NVRA data to the EAC.

Further (via Judicial Watch):

Counties typically do not ignore their reporting obligations to the EAC where the data is favorable to them. Rather, this failure suggests non-compliance with the NVRA. In all, 66 of Illinois’ 108 jurisdictions – or 60% of them – either reported fewer unusually low NVRA removals or failed to report a crucial data category to the EAC. These jurisdictions contain a total of 5.8 million registered voters, or about two thirds of Illinois’ 8.8 million registered voters.

In its complaint, Judicial Watch references a Notice Letter sent in November 2023 to Matthews before filing suit. This letter recounted these failures, and also observed that recent census estimates of citizens over the age of eighteen “suggests that 15 Illinois jurisdictions have more voter registrations than citizens of voting age.”

Illinois’ voting rolls are a mess. Dirty voter rolls can mean dirty elections,” said Judicial Watch President Tom Fitton. “Illinois should take immediate steps to clean its rolls to both prevent fraud and increase voter confidence in the elections.”

Judicial Watch is a national leader in voting integrity and voting rights. As part of its work, Judicial Watch assembled a team of highly experienced voting rights attorneys who stopped discriminatory elections in Hawaii, and cleaned up voter rolls in across the country, among other achievements.

https://www.zerohedge.com/political/dirty-voter-rolls-dirty-elections-illinois-sued-clean-mess

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GOP: Podesta appointment unlawful without Senate confirmation

Top Republicans on the House Energy and Senate Environment committees suggested in a letter to the White House on Wednesday that President Biden’s replacement of special climate envoy John Kerry with John Podesta is unlawful without Senate confirmation under a 2021 law.

In the letter, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Senate Environment and Public Works Committee ranking member Shelley Moore Capito (R-W.Va.) said Biden replacing Kerry without confirmation would violate the terms of the National Defense Authorization Act for fiscal 2022, which requires Senate confirmation for all special envoy positions within the State Department.

Podesta’s position is under the aegis of the White House rather than the State Department, which was where Kerry’s position was based. However, Capito and Rodgers wrote that as Podesta is set to have the same portfolio, “any objective observer would reasonably suspect that you crafted Mr. Podesta’s ‘new’ position to circumvent a recently enacted law so as to duck accountability to Congress and impede or subvert oversight efforts.”

Kerry, appointed to the climate envoy position in 2021, announced in January that he would depart to advise Biden’s reelection campaign. He confirmed earlier this week that he would officially leave the position Wednesday. Podesta, named a White House climate adviser after the passage of the Inflation Reduction Act, has been given the title “senior advisor to the president for international climate policy,” rather than Kerry’s “special presidential envoy for climate.”

Capito and Rodgers are not the first Republicans to call for Podesta to face the full Senate before taking on the job. In February, Senate Foreign Relations Committee ranking member James Risch (R-Idaho) said in a statement to The Hill that “[a]ny appointed administration official that will heavily rely on State Department staff and resources should be accountable to congressional committees with jurisdiction over State, including the Senate Foreign Relations Committee.” 

Reached for comment, a White House official told The Hill “Upon Secretary Kerry’s departure, the existing SPEC State team will report to Rich Verma, the Deputy Secretary of State for Management and Resources. John will continue to oversee the White House Office of Clean Energy Innovation and Implementation while working closely with the State Department.”

https://thehill.com/policy/energy-environment/4513608-republican-lawmakers-suggest-podesta-appointment-unlawful-without-senate-confirmation/