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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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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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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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BMS lines up follow-up indication for cardiomyopathy drug Camzyos

pharmaphorum

Bristol-Myers Squibb is going after a second indication for its first-to-market cardiac myosin inhibitor Camzyos, a drug tipped to be a future blockbuster and the top prospect in the company’s growing cardiovascular pipeline. The FDA is due to decide on the new label by 16 June next year.

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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. The average patient lost 15.7% of body weight over the course of the trial, surpassing the 9.6%

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New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine

Legacy MEDSearch

The study included 409 participants across the entire USA who used Nerivio device for acute treatment of migraine for 12 consecutive months, reporting their data prospectively. As for clinical efficacy, 74.1% of the participants reported consistent 2-hour pain relief, and 26% reported consistent pain freedom.

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Time to shape the future of DTC

World of DTC Marketing

Second, do people trust the FDA? ” 2wo: Physicians are still the gatekeepers of new Rx’s. For them, it’s about two things: relevant data that can be corroborated and improvements in patient outcomes. What does the data mean to the average patient, and why should they consider your product? 5ive: Please!

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