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FDA approval for Janssen’s prostate cancer treatment

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Lessons Learned from CMS’ Alzheimer’s Drug Coverage Decision

PM360

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. When used in CMS-approved prospective comparative studies, the data for which may be collected in a registry.

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Brazilian federal court denies semaglutide patent extension

Pharmaceutical Technology

Revenue prospects for Novo Nordisk’s blockbuster diabetes and weight-loss drug semaglutide in Brazil have been dealt a major blow after a federal court denied a request by the Danish firm for two patent extensions. Back in Brazil, however, the denial of semaglutide patent extensions is a loss for Lilly, too.

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Watch These 4 Large Drug Stocks Amid the Booming Industry

Contrarian Sales Techniques

In 2021, the demand for physician-administered drugs decreased due to the outbreak. Bright Prospects Indicates by Zacks Industry Rank The large-cap pharmaceutical industry, which is a part of the Medical sector, has a favorable Industry rank of A. The US Food and Drug Administration (FDA) has approved Wegovy, which is a 2.4-mg

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Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

Legacy MEDSearch

The results were featured in the late-breaking session ( LBA01-05 ) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30 th. Results from the trial are under review by the FDA. We continue to work with the FDA and look forward to introducing this innovative solution to physicians and patients.”

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Building Your Brand In Medical Device Sales With Pat Kothe

Evolve Your Success

My partner is an emergency medicine physician. We have launched into the US marketplace and got the product design through FDA. Those revisits that healthcare facilities and physicians have are not covered. Sometimes they go back to the primary care physician to do it. You can do that up to five times.

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