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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

FDA 234
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Leading in Pharma: a woman’s pathway

European Pharmaceutical Review

After moving to London in 2011, Ekaterina worked in global health and medical philanthropy, focusing on improving outcomes in maternal and child health. I used to prescribe antidepressants for patients but never considered psychiatry as a profession. Click here to read EPR’s previous ‘ Women Inspiring Pharma’ series.

Leads 52
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Transforming Patient Centricity to Patient Inclusive within Medical Affairs

PM360

What is the value of a patient-centric approach if that approach doesn’t include the patients themselves? They want a patient inclusive approach. More specifically, what role is Medical Affairs playing in working with patients to create educational materials that would make sense to fellow patients?

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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. Porath also found that technology overuse leads to increased exposure to negativity and misinformation. However, if you prioritize the health and well-being of your staff and the patients they treat—accolades are likely to follow.

Patients 108
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 As of October 2023, 62.93

Safety 110
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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

Myelofibrosis is a rare bone marrow cancer that causes the dysfunctional production of blood cells, leading to extensive bone marrow scarring, causing severe anaemia. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011. people per every 100,000 individuals in the US.

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Targovax announces plans to rebrand as Circio

Pharmaceutical Technology

Initially reported in 2011, CircRNA is a naturally occurring class of RNA. Based on extensive experience, our leading circRNA scientists have invented a clearly differentiated vector system to generate circRNA in target tissues. Circio CEO Dr Erik Digman Wiklund said: “CircRNA offers important functional advantages over mRNA.