AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn’s disease. The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery. The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and ...
After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing. Monday, the Department of Health and Human Services (HHS) argued that Merck can’t sue the agency because it isn’t the primary manufacturer for the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026. Simply put, HHS argues a Merck subsidiary is the company set to face the negotiation process, not Merck itself. Merck has argued it stands to suffer harm from the price negotiations because it developed and markets Januvia. But that assertion is “incorrect,” according to HHS, because a “non-party” to the lawsuit, Merck Sharp & Dohme, holds the FDA license to Januvia. “Accordingly, [the Centers for ...
Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
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 ...
By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
Reasoning skills are crucial skills in learning, academic performance, and everyday problem-solving. According to a recent study conducted at the University of Eastern Finland, improved overall diet quality and reduced consumption of red meat, as well as increased time spent in reading and organised sports enhanced reasoning skills among children over the first two school years. Sehrish Naveed, Doctoral Researcher, University of Eastern Finland, said, “Children with healthier eating habits showed greater cognitive development than other children. Specifically, better overall diet quality, lower red meat consumption, and higher low-fat dairy product intake were linked to better reasoning skills.” Children who spent more time in reading and organised sports showed better reasoning skills than their peers. On the other hand, excessive time spent on a computer and unsupervised leisure-time physical activity were associated with poorer reasoning skills. Screen time, active school transportation, recess physical activity, and physical activity intensity were not ...
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