In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow. The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk’s total revenue. While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same ...
MU Biotech Circle Recently, Eli Lilly announced plans to directly sell single dose vials of its weight loss drug Zepbound (tirzepatide) to consumers. The new prices for 2.5mg and 5.0mg doses are $99.75/vial and $137.25/vial, respectively, with corresponding monthly costs of $399 and $549, respectively, with a price reduction of over 50%. Novo Nordisk may adopt a similar strategy towards its Wegovy, with specific details to be revealed by its CEO during a Senate Health Committee hearing on September 24th. Analysts have responded positively to Eli Lilly’s move to lower Zepbound prices and offer the drug through its new self funded pharmacy component on its direct to consumer platform LillyDirect (launched in January this year). Joon Lee, an analyst at Truist Securities, believes that given the high demand for patients willing to purchase at their own expense, there is no reason why other GLP-1 manufacturers should not adopt similar strategies. ...
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
The US Food and Drug Administration (FDA) has rejected the biologics licence application (BLA) for Novo Nordisk’s once-weekly insulin icodec for the treatment of diabetes mellitus. The company did not disclose the details of the complete response letter (CRL) issued by the FDA. But did share that the CRL outlined concerns related to the “manufacturing process and the type 1 diabetes (T1D) indication”. Novo Nordisk also added that the company did not expect to fulfil the requests detailed in the CRL by the end of this year, and consequently will not be refiling the BLA for insulin icodec until next year, at the earliest. The BLA rejection news comes two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted against the approval of insulin icodec for T1D. In a 7-4 vote, the panel found that insulin icodec’s benefits do not outweigh its risks, especially the elevated risk ...
Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters. In all last year, the AAPCC revealed that there were 3,316 calls from users of semglutide, the active ingredient in Ozempic. It was more than double the number of calls from the previous year and a 15-fold increase from 2019, according to CNN. Most of the calls were for severe episodes of the commonly known side effects of semaglutide, which include nausea, vomiting and stomach pain. Most cases were resolved with intravenous fluids and nausea medications. Of the three dangerous U.S. cases of low blood sugar, also known as hypoglycemia, the AAPCC suspected the users were supplied with fake versions of semaglutide. All three cases were reported from the same regional poison control center, of which there are 55 ...
Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs. The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that ...
As high-flying Novo Nordisk continues its global manufacturing expansion, the GLP-1 maker has expanded its reach with a $92.5 million plant buy from Alkermes. The deal, which is expected to close in mid-2024, gives Novo the keys to Alkermes’ development and manufacturing site and its approximately 400 employees in Athlone, Ireland, the companies said in a press release. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” Novo’s senior vice president of product supply emerging technologies, Thilde G. Hummel Bøgebjerg, said in a statement. The 400 employees Novo will bring on board have “valuable capabilities within oral drug development and manufacturing,” Bøgebjerg added. The staff switchover marks an “exciting opportunity for growth” for the employees, Alkermes CEO Richard Pops added. For now, the companies will ink subcontracting ...
In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday, the Indianapolis-based company scored FDA approval for its GIP/GLP-1 compound tirzepatide to treat obesity, which will allow broader access to the treatment in the U.S. Dubbed Zepbound, Lilly’s new product is the same formula as blockbuster Type 2 diabetes drug Mounjaro. Since it was endorsed by the FDA in May 2022, Mounjaro has gained widespread, off-label use to treat obesity. Now, Zepbound has been indicated for adults with a BMI of 30 or higher as well as those with a BMI of 27 or higher with weight-related problems such as hypertension, Type 2 diabetes, sleep apnea or cardiovascular disease. With the FDA nod, Lilly now has its answer to Novo’s blockbuster duo of Ozempic for diabetes and Wegovy for obesity. The Danish company gained FDA green lights ...
Collaboration based on Valo’s large human dataset and computation powered by artificial intelligence. Image Credit: Adobe Stock Images/Shutter2U Novo Nordisk and Valo Health revealed that they have struck a deal to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). According to Novo Nordisk, this will include access to real-world patient data, AI-enabled small molecule discovery and Biowire human tissue modeling platform designed to speed up the discovery and development process. As per terms of the deal, Valo will receive an upfront payment and a potential near-term milestone payment of $60 million, with the potential to earn additional milestone payments up to $2.7 billion, plus R&D funding and potential royalty payments. “Artificial Intelligence and machine learning hold the promise to positively impact drug discovery and development, in particular enabling our vision of leveraging human datasets early in the ...
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