Top Regulatory News Stories – Week Ending June 21, 2019

Blueprint Medicines announced it has submitted a NDA to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST.  https://www.drugs.com/nda/avapritinib_190614.html?utm_source=ddc&utm

The FDA announced that generic drug applicants will now have access to more information from the agency when deciding whether to file a generic drug application.  https://www.raps.org/news-and-articles/news-articles/2019/6/fda-releases-new-data-to-help-generic-drug-competi?feed=Regulatory-Focus

Melinta Therapeutics  announced the FDA has accepted a sNDA for BAXDELA® (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).  http://ir.melinta.com/news-releases/news-release-details/melinta-therapeutics-announces-us-fda-acceptance-supplemental

CARsgen Therapeutics announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received IND clearance from the FDA.  https://www.firstwordpharma.com/node/1648373

The FDA’s Office of Prescription Drug Promotion (OPDP) recently released its third untitled letter of 2019 because of a direct-to-consumer video on Aclaris Therapeutics’ Eskata (hydrogen peroxide) that failed to adequately present the drug’s serious risks.  https://www.raps.org/news-and-articles/news-articles/2019/6/fdas-opdp-sends-third-untitled-letter-of-2019?feed=Regulatory-Focus

In other news…

Pfizer announced Monday that it entered into a definitive merger agreement to acquire Array BioPharma for $48 per share in cash, or a total enterprise value of approximately $11.4 billion  https://www.firstwordpharma.com/node/1647770

BieGene and SpringWorks are launching a new company called “MapKure” to develop a new cancer program: https://endpts.com/right-back-at-you-pfizer-beigene-and-a-pfizer-spinout-launch-a-newco-to-develop-a-mek-braf-inhibitor-that-could-rival-11-4b-combo/

Bluebird bio reported that its gene therapy launch will be delayed until early 2020 due to some manufacturing changes: https://www.biopharmadive.com/news/bluebird-delays-gene-therapy-launch-to-2020-citing-manufacturing-tweaks/557107/

Stoke Therapeutics raised $142 million through an IPO this week to test an experimental therapy for a rare form of epilepsy. https://xconomy.com/boston/2019/06/18/stoke-therapeutics-upsizes-ipo-raises-142m-for-dravet-drug-rd/?utm

Sanofi is to cut 466 jobs in France and Germany as part of the reorganization of its R&D group. The job losses are part of a pivot away from cardiovascular diseases and toward immuno-oncology drugs and gene therapies.  https://www.fiercebiotech.com/biotech/sanofi-to-ax-466-jobs-step-up-focus-cancer-gene-therapy-r-d   Following news of job cuts in European, Sanofi also confirmed it’s offering US workers an ‘early exit’. https://endpts.com/following-news-of-job-cuts-in-european-rd-ops-sanofi-confirms-its-offering-us-workers-an-early-exit/

uniQure is considering selling amid interest from large pharma buyers. This report follows the revitalization of uniQure’s hemophilia B prospect and accompanying triple-digit stock price surge. https://www.fiercebiotech.com/biotech/uniqure-weighs-sale-after-hemophilia-gene-therapy-turnaround-report

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   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

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