Industry news

• Shortage of childhood cancer drug hot topic during Senate hearing for new head of FDA

  22 November 2019 Eric Palmer / FiercePharma

  The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, the chief medical executive at MD Anderson Cancer Center who is expected to be confirmed as the FDA Commissioner. 

• Could this ring-shaped DNA change how we treat cancer?

  22 November 2019 Angus Liu / FiercePharma

  In the past, cancer researchers have mainly focused on targeting genes that are located on the chromosome. But a type of doughnut-shaped DNA that resides outside of the chromosome may give cancer cells their malignant qualities, suggests a team led by scientists at the University of California, San Diego (UCSD) branch of the Ludwig Institute for Cancer Research and Stanford University.

• FDA Commissioner nominee Hahn promises to put science above politics

  21 November 2019 Eric Sagonowsky / FirecePharma

  The would-be replacement for departed FDA Commissioner Scott Gottlieb faced a Senate committee's grilling Wednesday, and he supported drug-pricing action—and science.

• New Schizophrenia Drug Tested in Russia

  21 November 2019 GMP News

  The Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences conducts clinical trials of a remedy for schizophrenia, manic-depressive syndrome and other anxiety disorders, said Maxim Korolev, deputy head of the ICG branch.

• 17 Drugs Registered in the Russian Federation, including Generic Pomalidomide

  20 November 2019 GMP News

  The Russian Ministry of Health approved the first generic immunomodulator pomalidomide for the treatment of orphan disease – multiple myeloma. Information on this is available on the website of the State register of registered drugs in Russia (SRRD). The first generic of the choleretic drug gimecromona was also approved.

• BioCity UK Life Science Start-Up Report Reveals ‘Baby Boom’ of New Life Science Ventures

  20 November 2019 GMP News

  BioCity, the pioneering life science incubator and business collective releases its biennial publication, the UK Life Science Start-Up Report, an in-depth analysis of emerging businesses within the life sciences across the UK. The report has collected, analysed and interpreted data for nearly a decade and a half; and is a key publication for the life science industry.

• The Health-Changing Impact of Positive UX

  20 November 2019 FiercePharma

  Intent-driven research often leads to action. Wouldn’t you want to fix what’s bothering you? Most people would. Recently, research firm KR&I conducted a month-long digital ethnographic study (sponsored by Verywell). They found that a whopping 78 percent of participants reported taking specific actions in response to a health issue.

• Thwarting Subjectivity in Clinical Trials

  19 November 2019 Dr. Nathaniel Katz / FiercePharma

  

  No one would proceed with a clinical trial if a key measurement tool — a thermometer or fMRI, for example — was improperly calibrated. So why don’t we hold our participants, who are arguably the most critical component of any trial, to a similar standard of calibration?

• EMA Recommended Seven New Medicines for Approval

  19 November 2019 GMP News

  EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting. The Committee recommended granting a marketing authorisation for Isturisa* (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. It leads to patients experiencing weight gain, fat build-up on the face and bruising.

• Clarity and value of distribution partners beyond pick, pack and ship

  18 November 2019 Rebecca Willumson / FiercePharma

  Like all of us, drug manufacturers are having to navigate the constantly shifting and often times confusing healthcare ecosystem that stretches from development through regulatory approval, commercialization and ultimately to the patient. At the core of that ecosystem is a complex yet little understood aspect – distribution.