Regulatory Index News w/c 25 November 2019

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


NICE approves Ibrance via Cancer Drugs Fund

The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Ibrance (palbociclib), through the Cancer Drugs Fund (CDF), for use in combination with fulvestrant for the treatment of women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer, who have received prior endocrine therapy.

To read more follow this PharmaTimes link


Before 2019 closes, the FDA has 3 key approval decisions to make

The Food and Drug Administration is on an atypical streak of speedy approvals. Over the last few weeks, the agency greenlit medicines from Novartis, Vertex, BeiGene, Alnylam Pharmaceuticals and Global Blood Therapeutics months ahead of schedule, helping to prop up a year that hasn't seen as many new drugs hit the market as its predecessor.

To read more follow this BioPharmaDive link


Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo

The Food and Drug Administration on Monday approved Global Blood Therapeutics' sickle cell drug voxelotor, completing a rapid review that took the regulator about 90 days. 

To read more follow this BioPharmaDive link


Psoriasis causes lack of sleep, new study shows

A new report, conducted by the Psoriasis Association and LEO Pharma, has found that over 40% of people with psoriasis experience regular sleep disruption, with many losing up to two weeks of sleep a month.

To read more follow this PharmaTimes link


ImmuPharma, Avion ink Lupuzor deal

ImmuPharma and Avion Pharmaceuticals have signed an exclusive licensing agreement for Lupuzor (rigerimod), ImmuPharma’s lead compound, a peptide therapeutic and a first-in class autophagy immunomodulator for systemic lupus erythematosus (SLE or lupus).

To read more follow this PharmaTimes link


Takeda sees cell, gene therapy in its future. Is it too late?

Thanks to a $62 billion acquisition of Shire, Takeda is one of the world's largest developers of rare disease drugs.  Despite that, the 238-year-old Japanese pharmaceutical company lacks any mid- or late-stage cell or gene therapies, two technologies that figure to play a large role in how many rare cancers and inherited diseases will eventually be treated.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

29th November 2019

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