Regulatory Index News w/c 16 December 2019

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


AstraZeneca lupus drug shows potential, but it may not be enough for FDA

AstraZeneca's lupus drug anifrolumab reduced disease activity in nearly half of patients in the TULIP-2 trial, significantly more than the 32% of patients on placebo who saw improvement. The results of the trial were published Wednesday in the New England Journal of Medicine.

To read more follow this BioPharmaDive link


Roche recruits Rheos to explore immunometabolism

Roche and Rheos Medicines have announced a new collaboration to develop and commercialise novel therapeutics in the field of immunometabolism.  Rheos - a biopharmaceutical company harnessing insights in immunometabolism to create a new class of therapeutics. . . . . 

To read more follow this PharmaTimes link


Rinvoq gains EU approval for rheumatoid arthritis

AbbVie has announced that the European Commission (EC) has granted marketing authorisation for Rinvoq (upadacitinib) for certain patients with moderate to severe active rheumatoid arthritis.

To read more follow this PharmaTimes link


Jazz lines up $1B for lung cancer drug, making oncology focus clear

Jazz Pharmaceuticals, best known for its narcolepsy drugs, is joining many of its industry peers in staking its future to oncology, announcing Thursday a licensing deal that gives it access to a near-market lung cancer drug.

To read more follow this BioPharmaDive link



Ultragenyx sells European royalty stake in rare disease drug for $320M

Ultragenyx Pharmaceutical sold European royalty rights to one of its two commercialized drugs in a $320 million sale to Royalty Pharma, the biotech said Wednesday. 

To read more follow this BioPharmaDive link


Scotland gives Roche’s haemophilia A drug the go-ahead

NHS Scotland has approved the reimbursement of Hemlibra (emicizumab), Roche’s severe congenital haemophilia A treatment for patients without factor VIII inhibitors.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

20th December 2019

Come and join our community!

We are ready and waiting for you

We use cookies. By continuing to browse the site or closing this message you are agreeing to our Terms and Privacy Policy

ACCEPT and Hide This Message