Top Regulatory News Stories – Week Ending March 30, 2018

Hey folks, I’m posting this a day early since I will be taking off for a long weekend.  Here are the top regulatory news stories for this week:

The EMA’s Committee for Medicinal Products for Human Use (CHMP) rejected two drugs where were approved by US FDA in 2017 (betrixaban and abaloparatide):

GSK’s Shingrix has received approval in Europe and Japan for the prevention of shingles in adults aged 50+

Mylan and Biocon announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP)

Novo Nordisk’s Tresiba received approval for a labeling change which could sharpen its safety edge

Seattle Genetics and their partner Astellas received a Breakthrough Drug Designation for enfortumab vedotin which is currently in a Phase II study for metastatic urothelial cancer.

Ipsen announced that the EMA, the European regulatory authority, has validated the filing of a new application for an additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).

BioMarin announced that the EMA has accepted their MAA for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, for the treatment of adults with phenylketonuria (PKU)

The FDA is working on around a dozen actions to boost use of biosimilars, the head of the agency Scott Gottlieb said on Wednesday.

The FDA is inviting stakeholders to help in developing guidance on Patient-Focused Drug Development

In other news…

Gene editing company Homology landed $144M in their IPO offering of 9 million shares at $16 each.

Edge Therapeutics has halted a phase 3 trial of their aneurysmal subarachnoid hemorrhage treatment and is preparing to lay off staff.

Celgene and bluebird bio announced an agreement to co-develop and co-promote the latter’s investigational anti-BCMA CAR-T cell therapy bb2121 for the treatment of relapsed/refractory multiple myeloma in the US.

Unum Therapeutics netted $62million for cell therapy cancer trials in a Nasdaq IPO

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