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
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