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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. Article: The potential of tryptamines in treatment-resistant depression… The post Leading in Pharma: a woman’s pathway appeared first on European Pharmaceutical Review.

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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

A separate analysis by the same research team, also published Monday by JAMA Internal Medicine, found that in 2018, nearly 60% of cancer patients with private insurance nationally received an oral targeted treatment that did not lead to improved overall survival in clinical trials.

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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.

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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 EMA/95098/2010.

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

To achieve this objective, the regulation amends Directive 2011/24/EU on the application of patients’ rights in cross?border Directive 2011/24/EU had the merit of drawing attention to the need for an appropriate and centralised assessment of health technologies but failed to ensure effective harmonisation on the issue. Lorgelly PK.,

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BMS lawsuit claims AZ’s Imjudo infringes Yervoy patents

pharmaphorum

BMS’ lawsuit claims that Imjudo (tremelimumab) infringes two patents covering its own CTLA4 drug Yervoy (ipilimumab), which has been on the market since 2011 and is a key component of combination therapies for cancer with BMS’ PD-1 inhibitor Opdivo (nivolumab).

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