Regulatory Index News w/c 17 Dec 2018

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


Seven medicines leap closer to EU approval

The European Medicines Agency’s human medicines committee (CHMP) has put forward seven medicines for approval in the region.

To read more follow this PharmaTimes link


GSK, Pfizer to launch consumer joint venture in market-shifting partnership

GlaxoSmithKline and Pfizer will partner to create an expansive consumer health joint venture that will rank first globally in the sale of over-the-counter medicines, bringing top brands like Advil, Excedrin and Centrum together under one business.

To read more follow this BioPharmaDive link


Aduro inks deal with Lilly, driving shares higher

Aduro Biotech and Eli Lilly plan to work together to develop immunology treatments, announcing a deal on Tuesday 18th December, in which Lilly will license molecules from Aduro that target an immune pathway known as the intracellular stimulator of interferon genes, or STING.

To read more follow this BioPharmaDive link


EU & NICE authorise MSD's Keytruda for stage III melanoma

MSD’s Keytruda has been given a green light for use within the EU as an adjuvant treatment for stage III melanoma, and has also been made available on the NHS.

To read more follow this PharmaTimes link


Alkermes and Biogen announce new MS drug application for FDA

Alkermes and Biogen have announced that Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for diroximel fumarate.

To read more follow this PharmaTimes link



Vertex chalks up another win for pain drug

Vertex Pharmaceuticals on Tuesday reported more positive clinical data for its most advanced pain drug, reinforcing the biotech's stance that its scientific capabilities go beyond cystic fibrosis.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

21st December 2018

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