Eli Lilly and Incyte Corporation announced that the FDA has approved OLUMIANT (baricitinib) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults
Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS). Leukine is the first drug for H-ARS to demonstrate an improvement in survival when initiated 48 hours after radiation exposure. https://www.prnewswire.com/news-releases/partner-therapeutics-ptx-announces-us-fda-approval-of-leukine-sargramostim-for-the-treatment-of-acute-radiation-syndrome-300660612.html
Mylan and Biocon Ltd. announced on Monday that the FDA has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim): https://www.prnewswire.com/news-releases/us-fda-approves-mylan-and-biocons-fulphila-pegfilgrastim-jmdb-the-first-biosimilar-to-neulasta-300659410.html
Alnylam Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to ALN-TTRsc02, an investigational RNAi therapeutic for the treatment of transthyretin-mediated amyloidosis. http://www.firstwordpharma.com/node/1570078#axzz5HT1ZtPDS
Audentes Therapeutics announced that the EMA has granted Priority Medicines (PRIME) designation to AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM). https://www.prnewswire.com/news-releases/audentes-announces-priority-medicines-prime-designation-granted-by-the-european-medicines-agency-to-at132-for-the-treatment-of-x-linked-myotubular-myopathy-300659569.html
Europe’s CHMP turned thumbs down on Sarepta’s Exondys51 (eteplirsen) for Duchenne muscular dystrophy but embraced an expansion of PTC’s ataluren. https://endpts.com/the-fda-and-the-ema-go-their-separate-ways-on-dmd-chmp-slaps-down-sarepta-but-offers-rival-ptc-an-expanded-market/?utm
At the American Society of Clinical Oncology (ASCO) meeting in Chicago this week, FDA commissioner Dr. Scott Gottlieb steps to streamline the approval process for cancer drugs. https://www.reuters.com/article/us-health-cancer-fda/fda-chief-outlines-new-ways-to-speed-cancer-drug-approvals-idUSKCN1IY0MP?
In a first of its kind report, the FDA says that generic drugs approved in 2017 led to $8.8 billion in cost savings during the calendar year, and $11.8 billion in savings through February 2018. https://www.raps.org/news-and-articles/news-articles/2018/6/fda-generics-approved-in-2017-led-to-88b-in-sav?feed=Regulatory-Focus
The FDA on Wednesday issued a new draft guidance giving device makers an overview of the types of feedback and meetings they can request during pre-submission phase as part of the agency’s Q-submission program. https://www.raps.org/news-and-articles/news-articles/2018/6/fda-updates-q-submissions-guidance-for-mdufa-iv-ch?feed=Regulatory-Focus
In other news…
French drugmaker Ipsen will be moving its US headquarters to Massachusetts, adding 200 jobs https://www.bostonglobe.com/business/2018/06/07/french-drugmaker-relocates-cambridge-adds-jobs-here/VjzSSctQhmdM2feFIJ6QhK/story.html
Cesca Therapeutics announced that it is reducing its workforce by approximately 25%, to a total of 60 full-time equivalent employees: https://globenewswire.com/news-release/2018/06/04/1516205/0/en/Cesca-Therapeutics-Announces-Reduction-in-Operating-Expenses.html
Tricida signaled plans to raise $150 million in an IPO, stockpiling cash to fuel the company’s NDA filing and commercial launch of its late-stage chronic kidney disease drug. https://endpts.com/ahead-of-ckd-drug-launch-tricida-to-raise-150m-in-ipo/?utm_medium=email&utm
Danish company Novo Nordisk is reportedly considering cost-cutting plans that would cut up to 3,000 jobs. https://www.biospace.com/article/novo-nordisk-considers-cutting-up-to-3-000-jobs/?s=89
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/