Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. The states argue Lilly is trying to use the deal to ward off future lawsuits by U.S. states. In a Tuesday filing in New Jersey federal court, lawyers for Arizona, Mississippi and Minnesota urged U.S. District Judge Brian Martinotti to delay approval of the deal unless it’s altered to make sure states can still file their own lawsuits over insulin prices. The states joined Illinois, Nebraska, Utah, Arkansas, Kansas and Montana in making their objections known this week. In a separate filing Monday, the group of six states argued that in light of local insulin price caps, Lilly was trying to settle claims valued at about $1 billion by offering price reductions that are already ...
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in the US has awarded a $2m grant to Amygdala Neurosciences to support investigational new drug (IND) application and early development of the aldehyde dehydrogenase (ALDH2) inhibitor for the treatment of alcohol use disorder. According to the 2021 survey by the NIAAA, 29.5 million people aged 12 years and older have experienced alcohol use disorder. Current treatments include behavioural therapy, medication, support groups, and counselling. ANS-858 is an investigational selective and reversible ALDH2 inhibitor, which has been reported to reduce craving and drug-seeking behaviour in preclinical studies. Amygdala CEO Brent Blackburn said in the press release: “This award will enable the development of ANS-858 through pre-clinical evaluation required of an investigational new drug (IND) application to the FDA.” There are multiple drugs currently in development for treating alcohol use disorder. These mainly investigate the use of psychedelic compounds, including Beckly Psytech’s ...
Eli Lilly on Friday said it will acquire Versanis, a privately held obesity drug maker, for up to $1.93 billion to boost the pharmaceutical giant’s weight loss treatment portfolio. Eli Lilly agreed to pay Versanis shareholders in cash, which will consist of an upfront payment and potentially subsequent payments if Versanis achieves certain “development and sales milestones.” Oakland, California-based Versanis, which was founded in 2021 by biotech investment firm Aditum Bio, has one experimental drug for obesity and potentially other conditions. Eli Lilly’s stock price rose 3% on Friday following the announcement. The deal is Eli Lilly’s latest attempt to capitalize on the weight loss industry gold rush, which began last year after Novo Nordisk’s blockbuster injections Wegovy and Ozempic boomed in popularity. An estimated 40% of U.S. adults are obese. Analysts project that the global weight loss drug market could be worth $100 ...
By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
Contract research organisation IRBM has announced an extension to its collaboration with US-based Merck & Co. (MSD) to develop peptide therapeutics. IRBM began as part of MSD, in 2000, before being spun off in 2010. Following the separation, the companies continued to work together on drug discovery, with the collaboration being expanded in 2020 to develop peptide therapeutics for coronavirus. Advances in phage and mRNA display platforms have accelerated peptide development in recent years. In particular, IRBM claims it has made major progress with half-life extension strategies and utilising formulation enhancers to support oral route administrations. IRBM told Pharmaceutical Technology that AI is beginning to play a part in peptide discovery, and that radiotheranostics was a rapidly growing area of interest. Italy-based IRBM draws upon expertise in peptide drug development to bring new candidates to fruition. It utilises a platform that covers the entire range of activities required to discover ...
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
Some compounding pharmacies are offering what they say are generic versions of the drugs, which have soared in popularity for weight loss. When Robin Langois, 58, was prescribed the weight-loss drug Wegovy last year, she couldn’t afford the high price tag after her insurance wouldn’t cover it. But she later discovered on TikTok that people could get their hands on what appeared to be the drug’s active ingredient, semaglutide, from compounding pharmacies for a fraction of the price. Langois, of Tucson, Arizona, said she was initially hesitant, because of safety concerns, but she eventually found a telehealth provider to write her a prescription. “I’m not 100% sure it’s what I’m getting,” Langois said. She noted, however, that she’s experienced feelings of fullness and weight loss, as well as nausea, a common side effect of the drug. “It’s working like it should,” she said. Either due to cost or ongoing shortages, ...
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