Search Results for “EHR” – Page 10 – media

Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

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 ...
- Source: drugdu
- 178
- September 12, 2023
US announces first ten drugs up for Medicare price negotiation

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 ...
- Source: drugdu
- 103
- August 31, 2023
CMS

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 ...
- Source: drugdu
- 93
- August 31, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

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 ...
- Source: drugdu
- 107
- August 30, 2023
Healthy diet and organized sports linked to better reasoning skills in children

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 ...
- Source: drugdu
- 116
- August 19, 2023
Eli Lilly announces positive results for Retevmo in phase 3 lung cancer study

Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
- Source: drugdu
- 200
- August 9, 2023
NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy

The National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document that does not recommend CSL Behring’s Hemgenix (etranacogene dezaparvovec) gene therapy for haemophilia B. The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors. In its guidance, NICE’s evaluation committee said that while there is clear evidence that the therapy reduces the number of bleeding episodes haemophilia B patients have each year, there is not enough evidence on how well it works in the long term, meaning cost-effectiveness estimates are “uncertain”. It also cited problems with the indirect comparison between the gene therapy and factor IX replacement therapies. Haemophilia B is a genetic bleeding disorder resulting from missing or insufficient levels of blood clotting factor IX, a protein needed to produce blood clots to stop bleeding. Patients ...
- Source: drugdu
- 107
- August 7, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 139
- July 28, 2023
Novartis Plans Appeal to Ward Off Entresto Generics

Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
- Source: drugdu
- 259
- July 12, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 133
- July 5, 2023

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