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):    https://www.raps.org/news-and-articles/news-articles/2018/3/ema%E2%80%99s-chmp-rejects-two-drugs-approved-by-us-fda-in

GSK’s Shingrix has received approval in Europe and Japan for the prevention of shingles in adults aged 50+ https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-europe-and-japan-for-the-prevention-of-shingles-in-adults-aged-50-and-over/

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) https://www.biospace.com/article/releases/mylan-and-biocon-receive-approvals-from-the-european-commission-and-tga-australia-for-semglee-biosimilar-insulin-glargine/?s=85

Novo Nordisk’s Tresiba received approval for a labeling change which could sharpen its safety edge https://www.fiercepharma.com/marketing/novo-nordisk-s-tresiba-snags-label-boost-highlights-hypo-safety

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.  https://endpts.com/fda-hands-a-breakthrough-designation-to-seattle-genetics-pivotal-stage-cancer-drug-enfortumab/

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). https://www.biospace.com/article/releases/ipsen-announces-ema-validation-of-filing-of-a-new-application-for-additional-indication-for-cabometyx-for-patients-with-previously-treated-advanced-hepatocellular-carcinoma-hcc-/?s=85

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) https://www.biospace.com/article/releases/european-medicines-agency-ema-accepts-biomarin-s-marketing-application-for-pegvaliase-maa-for-treatment-of-phenylketonuria-pku-/?s=85

The FDA is working on around a dozen actions to boost use of biosimilars, the head of the agency Scott Gottlieb said on Wednesday.  https://www.reuters.com/article/us-usa-healthcare-gottlieb/fda-working-on-a-dozen-policies-to-boost-copycat-biotech-drugs-idUSKBN1H41WN?

The FDA is inviting stakeholders to help in developing guidance on Patient-Focused Drug Development  https://www.raps.org/news-and-articles/news-articles/2018/3/fda-invites-draft-guidance-on-patient-focused-drug?utm

In other news…

Gene editing company Homology landed $144M in their IPO offering of 9 million shares at $16 each.  https://www.fiercebiotech.com/biotech/homology-lands-144m-upsized-ipo-to-advance-gene-editing-treatment

Edge Therapeutics has halted a phase 3 trial of their aneurysmal subarachnoid hemorrhage treatment and is preparing to lay off staff. https://www.fiercebiotech.com/biotech/edge-plans-jobs-cuts-as-phase-3-brain-bleed-fail-routs-stock

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. https://www.fiercebiotech.com/biotech/bluebird-celgene-to-share-u-s-costs-profits-lead-cancer-car-t

Unum Therapeutics netted $62million for cell therapy cancer trials in a Nasdaq IPO https://www.fiercebiotech.com/biotech/unum-ipo-hits-bottom-range-netting-62m-for-cell-therapy-cancer-trials

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com

 

 

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