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Merck challenges HHS on Medicare drug price negotiations, alleging violations of the Constitution

The pharma industry has voiced loud complaints about the Biden administration’s Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-selling pharmaceuticals. But now the industry is taking its arguments to the courts.In the first lawsuit of its kind, Merck & Co. is suing the Department of Health and Human Services for alleged violations of the First and Fifth Amendments to the U.S. Constitution, Reuters reports. Under the Inflation Reduction Act, Medicare will begin negotiating prices for the drugs that it spends the most on beginning in 2026. Because companies can’t exactly walk away from these negotiations, some industry leaders have said the setup is akin to “price controls.” Now, Merck alleges the negotiation setup is a violation of the Fifth Amendment, which requires the government to fairly compensate companies or individuals for property that is used for the public good, Reuters ...
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- June 8, 2023
Eisai hit with ransomware attack, launches investigation into possible data leaks

Eisai is the latest drugmaker to be hit with a ransomware attack.The Japanese company said it “immediately” set up a company-wide task force after suffering a cyberattack Saturday night. Now, it’s working to respond with external experts and law enforcement officials, Eisai said in a statement. The possibility of data leaks is currently under investigation, the company said. Eisai expects it will take “some time to gauge the full extent of the incident.” During the response, Eisai took some of its computer systems, both inside and outside of Japan, offline. For now, its corporate websites and email systems remain operational. As for the impact on the company’s earnings, Eisai is “carefully examining” any potential impact on its earnings forecast and will announce “as soon as possible” if revisions are necessary. Japan has seen an increasing amount of cyberattacks recently, according to The Japan Times. An official at the National Center ...
- Source: drugdu
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- June 8, 2023
Amgen’s Lumakras shows promise in phase 3 lung cancer study

Amgen has shared positive results from a late-stage study evaluating its KRAS inhibitor, Lumakras (sotorasib), in certain lung cancer patients. The phase 3 CodeBreaK 200 trial compared Lumakras to docetaxel chemotherapy in patients with previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). New data from the trial was presented at the American Society of Clinical Oncology (ASCO) annual meeting. NSCLC represents up to 85% of all lung cancer diagnoses. KRAS G12C is the most common KRAS mutation in NSCLC, Amgen reports, and patients with this mutation whose first-line treatment has failed face limited options. According to data from a post-hoc analysis of CodeBreaK 200, which included NSCLC patients with treated or stable central nervous system (CNS) lesions at baseline, Lumakras was associated with a delayed time to CNS progression and longer CNS progression-free survival (PFS) compared with docetaxel. Additionally, an assessment of CNS tumour shrinkage following ...
- Source: drugdu
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- June 8, 2023
Lawmakers worry Medicare Alzheimer’s plan won’t ensure access to new treatments

Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer’s treatments for seniors. Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work. The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still “very unclear” how seniors will access the new treatments. Medicare has promised to cover Alzheimer’s antibody treatments on the same day the medications receive full approval by the Food and Drug Administration. The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can’t administer at home on their own, such as infusions. Under this policy, seniors ...
- Source: drugdu
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- June 8, 2023
Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The FDA said Monday that Abiomed, the heart device maker bought by Johnson & Johnson last year for $16.6 billion, is recalling some sets of the Impella 5.5 heart pump with the SmartAssist function after receiving complaints that purge fluid has leaked from the purge sidearm of the pump. The FDA has identified the action as a Class I recall, the most serious kind, meaning that continued use may cause serious injuries or death, unless corrective measures are taken. The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy, the FDA said in a statement. The FDA warned that if a purge leak occurs, “the system ...
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- June 7, 2023
Freiburg researchers gain new insights into metabolic processes in the kidney

Researchers at the Faculty of Medicine at the University of Freiburg have gained significant new insights into metabolic processes in the kidney. The scientists from the Institute of Genetic Epidemiology at the Medical Center – University of Freiburg measured tiny molecules, so-called metabolites, which occur in blood and urine and reflect our metabolism, in samples from more than 5,000 study participants. They compared these with the genome of the test persons and were able to identify 1,299 genetic changes that are associated with metabolites and contribute to their production, degradation or transport. The findings provide a better understanding of processes throughout the body and particularly in the kidney, which produces urine from blood plasma. These discoveries, which appeared June 5, 2023, in the journal Nature Genetics, could lead to a better understanding of diseases and new approaches to their treatment. For example, a new class of therapies for treating diabetes, ...
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- June 7, 2023
AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

After a postmarketing study of AstraZeneca’s bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.In the study, investigators tested Andexxa versus standard care in more than 450 patients with intracranial bleeding who have received blood thinners called factor Xa inhibitors. Those who received the AstraZeneca drug experienced superior hemostatic efficacy compared with the control arm, AZ said in a Monday release. Hemostatic efficacy is a measure of the body’s ability to stop the flow of life-threatening brain bleeds. “We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required,” AZ’s executive vice president of biopharmaceuticals R&D, Mene Pangalos, Ph.D., said in a statement. Now, the company will look to convert Andexxa’s speedy approvals in ...
- Source: drugdu
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- June 7, 2023
Johnson & Johnson’s Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
- Source: drugdu
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- June 7, 2023
AstraZeneca shares positive phase 3 results for Tagrisso in lung cancer

AstraZeneca (AZ) has shared positive results from a late-stage study evaluating Tagrisso (osimertinib) as an additional treatment for certain lung cancer patients. The phase 3 ADAURA trial enrolled 682 patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who had undergone surgery to remove their primary tumour. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence. The results, which were presented at the American Society of Clinical Oncology annual meeting, showed that the drug reduced the risk of death by 51% compared to placebo in both the primary analysis population (patients with stages 2 to 3a EGFRm NSCLC) and in the overall trial population (stages 1b to 3a). In the primary analysis population, an estimated 85% of Tagrisso-treated patients were alive at five years compared to 73% in the placebo cohort. In the overall trial population, around 88% of ...
- Source: drugdu
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- June 7, 2023
Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading

Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
- Source: drugdu
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- June 7, 2023

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