Suzanne Hodsden

ISPE Previews Plan To Prevent Drug Shortages

Last week, International Society for Pharmaceutical Engineering (ISPE) released the introductory summary of its Drug Shortages Prevention Plan, with the goal of maintaining a reliable supply of life-saving medications to patients all over the world.

Could Breast Cancer Drugs Treat Brain Tumors?

Researchers at the University of Cincinnati (UC) are hoping for success in using aromatase inhibitors, such as letrazole (U.S. Brand name Femara), in the treatment of malignant primary brain tumors.

Big Pharma Seeks To Engage Patients “Beyond the Pill”

Recently, Forbes magazine published a column describing the new directions big pharmaceutical companies are pursuing to offset the turbulent business landscape of prescription drugs. Many of these efforts seek to offer value to a potential customer “beyond the pill.”  Forbes predicts that the coming years will show pharma dipping more and more into “The Internet of Things (IoT) to offer high-tech and personal solutions that will change the ways in which disease is monitored and managed.

What Will The Future Hold For Plantibodies In Big Pharma Manufacturing?

Using plants rather than mammalian cells to manufacture life-saving drugs could be quicker, cheaper, and more efficient, but according to a report by Reuters, big pharma companies have not yet invested in the new method, conservatively waiting to see how these new drugs pass the regulatory process before abandoning tried and true manufacturing systems.

E.U. Launches Pilot Project To Speed International Generic Drug Applications

The European Medicines Agency (EMA) announced a new project that will model the E.U.’s decentralized procedure (DCP) for assessing applications for generic medicines. In this new project, a part of the International Generic Drug Regulators Pilot (IGDRP), the DCP will share assessment reports with regulatory agencies outside the E.U.

WHO Prepared to Treat Ebola Patients With Experimental Treatments The World Health Organization (WHO) held an emergency meeting last week and announced they were ready to declare the outbreak of Ebola in West Africa a public health emergency. Moving forward, the WHO gathered a panel of experts to discuss the ethics of dispensing experimental treatments, which have never before been tested in humans, to patients and health workers in West Africa. Following conclusion of the panel, the WHO made the ruling that unapproved treatments can be used to treat or prevent an Ebola outbreak, providing certain conditions are met that warrant the use of experimental treatments.

Kyowa Hakko Kirin Moves Forward With KW-3357

After successful phase 3 clinical trials, Japanese company Kyowa Hakko Kirin has filed a marketing approval application for KW-3357, a recombinant human antithrombin used to treat patients with congenital anti-thrombin deficiency (CAD) and Disseminated Intravascular Coagulation (DIC) accompanied by a decrease in anti-thrombin.