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Are timely access and robust safety mutually exclusive?

pharmaphorum

And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better?

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

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Why Are Patients So Angry? Plus, Frontliner Tips for Health Leaders

Healthcare Success

The rate of injuries from violent attacks against medical professionals grew by 63% from 2011 to 2018. So, how can health leaders help frontline workers and other employees protect their mental and physical health while managing a steady stream of angry patients? Why are people so angry and rude? How did we get here?

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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

The double-blinded study investigated the efficacy of momelotinib compared to danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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Thursday pharma headlines

World of DTC Marketing

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma 180
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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

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