Regulatory Index News w/c 11 March 2019

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


Uveal melanoma study announced

Researchers have announced a study to identify new treatments that could improve survival rates for an uveal melanoma, a form of eye cancer.

To read more follow this PharmaTimes link


Aerie's eye drops win FDA approval

Aerie Pharmaceuticals has received Food and Drug Administration approval for eye drops that reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The biotech will market its new medicine under the branded name Rocklatan.

To read more follow this BioPharmaDive link


Celgene dodges Alvogen bid to overturn Revlimid patent

Celgene's patent position protecting its top-selling drug Revlimid looks more secure following a U.S. patent board's decision Thursday to rejectan attempt by generic drugmaker Alvogen to invalidate a patent covering the cancer therapy. 

To read more follow this BioPharmaDive link


EC extends license for Roche/Chugai’s Hemlibra

The European Commission has approved Roche and Chugai Pharma UK’s Hemlibra for the prevention of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors, expanding the drug’s treatment scope.

To read more follow this PharmaTimes link


AZ links with Seres in microbiome cancer immunotherapy pact

AstraZeneca is partnering with US group Seres Therapeutics to investigate use of the body’s microbiome to improve cancer immunotherapy.

To read more follow this PharmaTimes link


Dupixent label expansion opens door to thousands more patients

Sanofi and Regeneron's Dupixent has secured U.S. approval for the treatment of moderate-to-severe atopic dermatitis in adolescents — a label expansion that could increase the immunology drug's eligible patient population by at least 150,000, according to Sanofi estimates.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

15th March 2019

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