Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflation Reduction Act (IRA). The drugs that made the price negotiation cut are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel. Together, the drugs accounted for more than $45 billion in Medicare Part D spending from June 2022 to May 2023, according to a CMS fact sheet (PDF). Next up, these companies will get a chance to submit data and information on their medications to CMS by Oct. 2. Meanwhile, many of the companies are challenging the legality of the IRA in court. It remains to be seen whether any of those efforts can stop the IRA process ...
Boehringer Ingelheim could soon stake a claim in the lucrative obesity treatment market after the pharma company said it has advanced a candidate into three Phase III trials following promising data. Survodutide, the company’s glucagon/glucagon-like peptide 1 (GLP-1) receptor dual agonist co-developed with Zealand Pharma, demonstrated up to 19% weight loss after 46 weeks of treatment in a Phase II dose escalation trial investigating the drug in patients living with obesity without type 2 diabetes (T2D). In a statement announcing the plans, Boehringer Ingelheim said that insights from previous studies will be used to inform the design of the three Phase III trials which will investigate the efficacy and safety of survodutide. Enrolment of patients is planned before the end of 2023, with the company saying that study details will be unveiled nearer to trial commencement. Survodutide has previously received a US Food and Drug Administration (FDA) fast track designation ...
Amazon has announced that its online healthcare business, Amazon Pharmacy, will provide automated manufacturer-sponsored coupons for over 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The company said that patients will not need to search for and manually enter coupons using the new automatic coupon programme for three insulin makers: Novo Nordisk, Eli Lilly and Sanofi, lowering costs to as little as $35 a month. In March 2023, Novo, Lilly and Sanofi announced that they would be lowering their insulin prices by around 70% by or in 2024. A report published in July by Senator Elizabeth Warren said that some patients were struggling to get already discounted generic insulin from pharmacies at the guaranteed lower price. After Lilly lowered its Insulin Lispro list price in May to $25 per vial, patients were still being quoted up to $330 for the medicine and were ...
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 ...
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