This was a relatively quiet week for regulatory news. Here is my summary of the top regulatory stories in pharma and biotech:
The FDA provided draft guidance regarding a new program which will expand Priority Review Vouchers for medical countermeasure programs including therapeutics and prophylactics for conditions linked with chemical, biological, radiological and nuclear threats, and emerging infectious diseases: https://www.biopharmadive.com/news/fda-issues-prv-guidance-for-medical-countermeasures/515126/
FDA commissioner Scott Gottlieb changed his course on FDA publication of rejection letters https://endpts.com/fda-commissioner-scott-gottlieb-just-broke-a-public-promise-on-publishing-crls-and-yes-it-matters/
Five Prime Therapeutics has submitted an IND application for FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 https://www.contractpharma.com/contents/view_breaking-news/2018-01-04/five-prime-therapeutics-submits-ind-application/
Cantex Pharmaceuticals announced that FDA Orphan Drug Designation has been granted to CX-01 for treatment of Acute Myeloid Leukemia https://www.drugs.com/clinical_trials/cantex-pharmaceuticals-inc-announces-fda-orphan-designation-has-been-granted-cx-01-acute-myeloid-17696.html
Trevena, Inc. announced that the FDA has accepted their NDA for Olinvo (oliceridine) Injection https://www.drugs.com/nda/olinvo_180102.html?utm
Achaogen reported that the FDA accepted their NDA with Priority Review for Plazomicin for treatment of complicated urinary tract infections and bloodstream infections http://investors.achaogen.com/releasedetail.cfm?releaseid=1053003
Tetraphase Pharmaceuticals says it submitted an application to the FDA for approval of intravenous eravacycline for the treatment of complicated intra-abdominal infections. https://seekingalpha.com/news/3320783-tetraphase-pharma-submits-nda-intra-abdominal-infections-fda
Novartis announced that the FDA granted priority review to a filing seeking expanded approval of Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). In addition, the EMA granted accelerated assessment to Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) and for adults with r/r DLBCL who are ineligible for ASCT. https://www.firstwordpharma.com/node/1537433
In other news…
Adaptimmune Therapeutics announced that it has successfully manufactured the first SPEAR T-cells for a patient at its Navy Yard facility in Philadelphia. In addition, they announced an agreement with Cell and Gene Therapy Catapult for vector production in the UK, which will ensure vector supply for its ongoing and future clinical studies. https://www.firstwordpharma.com/node/1535540
The Wall Street Journal reported that Celgene Corp. was in talks to buy the Seattle-based drugmaker Juno Therapeutics in a move toward expanding its blood cancer drug portfolio. https://www.bloomberg.com/news/articles/2018-01-16/juno-therapeutics-shares-surge-on-report-of-celgene-deal-talks
Cambridge startup Pandion Therapeutics announced that it raised $58 million in series A financing: https://www.bizjournals.com/boston/news/2018/01/18/biogen-pfizer-vets-launch-autoimmune-disease.html
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