Hi folks, here are the top regulatory news stories to follow this week:
GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, Shingrix: https://www.reuters.com/article/us-usa-fda-gsk/gsk-wins-u-s-shingles-vaccine-approval-uk-nod-for-gene-therapy-idUSKBN1CS0TU
The FDA expanded its approval for Alexion’s blood-disorder drug Soliris to include treatment for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris was initially approved in 2007 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) https://www.drugs.com/newdrugs/fda-approves-alexion-s-soliris-all-patients-pnh-408.html
Tesaro Inc said on Wednesday that the FDA approved an intravenous version of its drug to treat chemotherapy-induced nausea and vomiting in adults. The oral version of Varubi was approved by the FDA in 2015. http://www.reuters.com/article/us-tesaro-fda/fda-approves-intravenous-version-of-tesaro-drug-for-chemotherapy-nausea-idUSKBN1CU3BL
The FDA has declined to approve PTC Therapeutics Inc’s experimental drug to treat Duchenne muscular dystrophy, saying an additional clinical trial would be needed to prove the drug works. https://www.reuters.com/article/us-ptc-therapeutics-duchenne-fda/fda-declines-to-approve-ptcs-duchenne-drug-idUSKBN1CU2GO
RedHill Biopharma received FDA orphan drug designation for MESUPRON for pancreatic cancer https://marketchameleon.com/PressReleases/pr?i=518804
BioMarin announced that the U.S. Food and Drug Administration (FDA) granted its valoctocogene roxaparvovec for Hemophilia A Breakthrough Therapy Designation. https://www.biospace.com/article/fda-calls-biomarins-hemophilia-a-drug-a-breakthrough
Medivir AB announced that the FDA has granted Fast Track designation for the company´s product candidate MIV-711, for the treatment of osteoarthritis (OA). https://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=247763
Alzheon’s alzheimer’s asset ALZ-801 has secured fast-track status from the FDA. http://www.fiercebiotech.com/biotech/alzheon-s-alzheimer-s-asset-boards-fda-fast-track-ahead-second-swing-at-phase-3
Synlogic announced that the FDA has granted Orphan Drug Designation to SYNB1618, Synlogic’s preclinical-stage drug candidate for the treatment of phenylketonuria (PKU) https://www.firstwordpharma.com/node/1516418
Emerald Health Pharmaceuticals which is developing medications based on cannabinoid science, today announced that the FDA has granted Orphan Drug Designation for its lead molecule, EHP-101, for the treatment of systemic scleroderma. https://www.firstwordpharma.com/node/1515366
An FDA advisory panel voted 16-0 with one abstention that Novo Nordisk’s GLP-1 analogue semaglutide should be approved for use in adults with type 2 diabetes. https://www.firstwordpharma.com/node/1514946
The FDA granted priority review to the application for an additional indication for the Exelixis cancer drug Cabometyx (cabozantinib). http://www.fdanews.com/articles/184044-enoxis-receives-priority-review-for-cancer-drug-indication
The FDA issued a draft guidance detailing the agency’s new program for breakthrough medical devices created by the 21st Century Cures Act. The new breakthrough devices program supersedes and combines several of the agency’s existing programs to speed access to new devices. http://www.raps.org/Regulatory-Focus/News/2017/10/24/28738/Breakthrough-Devices-FDA-Issues-Draft-Guidance
In other news…
Celgene Corp. announced that it is discontinuing development of its potential blockbuster immunology treatment mongersen in Crohn’s disease due to lack of efficacy. http://www.biopharmadive.com/news/celgene-crohns-drug/507797/
Incyte has just inked a $900 million deal to grab global rights to an early-stage PD-1 checkpoint now being developed at MacroGenics. https://endpts.com/incyte-grabs-a-new-pd-1-checkpoint-drug-in-900m-deal-with-macrogenics
The Medicines Co. announced plans to restructure the company, including laying off more than 85% of its workforce. http://www.marketwatch.com/story/medicines-co-shares-surge-8-on-planned-restructuring-layoffs-2017-10-25?siteid=yhoof2&yptr=yahoo
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