Regulatory Roundup: Top News Stories – Week Ending July 21, 2017

This was a relatively quiet regulatory news week when compared to the past few weeks.  Here is my summary of the top stories to follow:

The FDA approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer.

The FDA approved Gilead’s VOSEVI, a three-drug combination of sofosbuvir, velpatasvir and a new drug called voxilaprevir for the treatment of Hepatitis C.

Leo Pharma has secured approval from the European Commission for its Kyntheum (brodalumab) to treat moderate-to-severe plaque psoriasis.

The FDA has issued a complete response letter for Amgen and UCB’s filing seeking approval of Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis. The agency asked that efficacy and safety data from the trial be included in the application.

The FDA has given a tentative approval for Merck’s LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device.

Spark Therapeutics won priority review from the FDA and a January 12, 2018 deadline for voretigene neparvovec, a gene therapy for RPE65-mediated inherited retinal disease.

Abeona Therapeutics received a green light from the FDA in a Type-C meeting to kick off its Phase 3 trial of EB-101 gene therapy for recessive dystrophic epidermolysis bullosa (also known as the “butterfly disease).

In other news…

Sunovion Pharmaceuticals has agreed to sell the US market rights to several asthma and allergy products to Covis Pharma.  With the divestiture of these products, Sunovion is reinforcing its focus on chronic obstructive pulmonary disease (COPD) in the respiratory area.

Sarepta has reached a global settlement and license agreement with BioMarin over rights to exon-skipping technologies.  Under the agreement Sarepta will pay BioMarin an upfront payment of $15 million plus an additional $20 million in milestone payments.

Emergent BioSolutions has agreed to acquire GlaxoSmithKline’s anthrax monoclonal antibody, raxibacumab, for around $96m.

Vertex Pharmaceuticals has reported positive data from Phase 1 and Phase 2 trials of three different triple combination regimens in cystic fibrosis (CF) patients who have one F508del mutation and one minimal function mutation (F508del/Min).


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