The stakes are getting even higher for the fight between Eli Lilly and Novo Nordisk for supremacy in the multibillion-dollar obesity market. Lilly on Friday quietly registered a new phase 3b trial on clinicaltrials.gov. The study, coded SURMOUNT-5, will pit Lilly’s Mounjaro against Novo’s Wegovy in patients with obesity or overweight with weight-related health conditions. The trial aims to enroll 700 participants from 61 sites in the U.S., Canada, South America and several European countries, according to the post. The study is currently expected to officially start next Friday and last for about 78 weeks, with an estimated primary completion date in February 2025. On the study’s primary endpoint, investigators will compare the percentage weight changes between the two drugs by week 72 from baseline. However, it’s not immediately clear whether Lilly is designing SURMOUNT-5 as a superiority study to show Mounjaro is better than Wegovy or just to show ...
New results from a Phase IIIa study have demonstrated that Novo Nordisk’s weight loss drug semaglutide improved physical function and wellbeing among people with obesity. The STEP 1 trial demonstrated benefits for people with obesity treated with semaglutide 2.4mg ‘beyond weight loss’, Novo said in a statement. Over a 68-week period, treatment with once-weekly semaglutide 2.4mg was associated with greater improvements for all weight- and health-related quality of life scores in people with obesity or overweight in comparison to placebo. This included improved wellbeing, with 43.8% of patients treated with Novo’s drug achieving a clinically meaningful improvement in total weight-related quality of life score at week 68. On top of that, 51.2% of participants treated with semaglutide 2.4mg in the trial had an increased weight-related physical function score, reflecting improvements in the ability to perform daily activities. In addition, patients treated with semaglutide 2.4mg ‘simultaneously’ experienced significant weight loss of ...
Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...
Senator Bernie Sanders has targeted the high drug prices of Novo Nordisk’s Ozempic and Wegovy, revealing that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is investigating the “outrageously high” US prices of the blockbuster diabetes and obesity drugs. In a 24 April letter addressed to Novo Nordisk CEO Lars Fruergaard Jørgensen, Sanders, who serves as the HELP Committee chair, has requested answers from the multinational pharma by 8 May. The letter said the committee is investigating future reductions of the list and net prices of both Ozempic and Wegovy, R&D spending, cost and volume of goods sold, and prices paid by government payers. Additionally, Sanders requested that Novo Nordisk explain the price discrepancy between Wegovy and Ozempic given that they are different versions of the same drug, semaglutide, sold under two brand names. Sanders had previously put forth a proposal to cap prices on federally-funded drugs in ...
Novo Holdings, the Novo Nordisk Foundation’s holding and investment company, declared plans for a $16.5bn acquisition of Catalent as the company expands its manufacturing capabilities. In the merger, Novo Holdings will receive all outstanding shares of Catalent for $63.50 per share in cash. This price reflects a premium of 39.1% to the closing price of Catalent’s common stock on 28 August 2023. This date was the contract development and manufacturing organisation’s (CDMO) last trading day before announcing Catalent’s new strategic and operational review committee, which assessed the company’s business strategy and operations. The Catalent board unanimously advised Catalent stockholders to complete the merger. In a 5 February press release, Novo expressed plans to complete the deal towards the end of this year, dependent on closing conditions, which include gaining approval from Catalent’s stockholders and securing necessary regulatory approvals. Novo is flush with cash these days as is evident in Novo ...
When the Biden administration welcomed the passing of the Inflation Reduction Act (IRA) in August 2022, it marked a rare defeat for the pharmaceutical industry in Washington, D.C. Naturally, drugmakers didn’t lie down without a fight on the controversial topic of Medicare price negotiations. Now, new developments show that the Biden administration is willing to go to the mat in defense of the IRA negotiations. Wednesday, lawyers for AstraZeneca are set to engage in oral arguments against the U.S. Department of Justice in a federal court, according to a September court order and a new report from Bloomberg Law. The British drugmaker aims to challenge the legality of the drug pricing provisions put in place under the IRA, which will allow Medicare to haggle over the prices of some of the costliest drugs it covers starting in 2026. AstraZeneca’s diabetes blockbuster Farxiga ranks among the 10 drugs that were selected ...
A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said. Over the last several months, the agency has been looking into reports of suicidal thoughts or actions from users of the GLP-1 treatments gathered through its FDA Adverse Event Reporting System (FAERS), it said. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of (GLP-1s),” the FDA wrote. The agency said its reviews of clinical trials and observational studies found no association between the treatments and suicidal thoughts. Ten days ago, the FDA drew attention when it included the trendy therapies on a list of medicines it said it was monitoring for side ...
Dec 21 (Reuters) – The U.S. Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk’s (NOVOb.CO) diabetes drug Ozempic that have been found in the country’s drug supply chain. The health regulator said it will continue to investigate counterfeit Ozempic 1 milligram injections and has seized thousands of units, but flagged that some may still be available for purchase. Danish drugmaker Novo Nordisk and the FDA are testing the seized products and do not yet have information about the drugs’ identity, quality or safety, the agency said. Novo said the seizures took place in warehouses outside the company’s authorized supply chain. The agency said the needles from the seized injections are counterfeit and their sterility cannot be confirmed, which presents an additional risk of infection for patients. Other confirmed counterfeit components from the seized products include the pen label and accompanying information about ...
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