Regulatory Index News w/c 18 February 2019

Here is a selection of this week's news from around the world


FDA hits leukemia study with partial clinical hold

Xencor has announced that the US Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase I study of XmAb14045.

The drug is a bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia, along with other CD123-expressing haematologic malignancies.

To read more follow this PharmaTimes link 


FDA clarifies pathway for devices used in regenerative medicine

The Food and Drug Administration on Friday issued final guidance for the development of regenerative medicine therapies such as cell or tissue products, saying the treatments have the potential to address "hundreds of vexing human diseases and conditions."

To read more follow this BioPharmaDive link


After accelerated approval, Merck's Keytruda fails in liver cancer study

Merck & Co. disclosed Tuesday its cancer drug Keytruda failed a Phase 3 study in advanced liver cancer, less than four months after the immunotherapy gained an accelerated approval for a similar indication. 

To read more follow this BioPharmaDive link


New cancer drug payment system could speed up treatment

A new report, commissioned by Cancer Research UK and the Greater Manchester Health and Social Care Partnership, suggests that paying for cancer drugs based on how well they work in practice could help patients get new treatments faster.

To read more follow this PharmaTimes link


Cell therapy trial shows 'significant' vision restoration

ReNeuron has found ‘significant restoration of vision’ in patients with retinitis pigmentosa given its human retinal progenitor cells (hRPC) cell therapy.

To read more follow this PharmaTimes link


FDA to accept drug plant inspections by Poland, Slovenia

Drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the Food and Drug Administration, allowing the agencies to share information gathered through their oversight of manufacturing facilities.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

22nd February 2019

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