AbbVie received FDA approval for elagolix, the first new oral drug approved for endometriosis pain in more than a decade. The drug will be rolled out into the marketplace under the name Orilissa. https://endpts.com/following-some-clean-sweeps-in-phiii-abbvie-gets-an-fda-ok-on-its-top-10-blockbuster-prospect-orilissa/?utm
The FDA approved the 12th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible indications of the reference product. https://www.raps.org/news-and-articles/news-articles/2018/7/fda-approves-12th-biosimilar-2nd-for-filgrastim?utm
Sarepta Therapeutics announced that its Phase 1/2a Duchenne Muscular Dystrophy micro-dystrophin gene therapy trial was placed on clinical hold due to an out-of-specification production lot. https://www.firstwordpharma.com/node/1581123
The FDA has granted orphan drug designation to Corbus Pharmaceutical’s lenabasum for the treatment of dermatomyositis, a systemic autoimmune condition characterized by skin and muscle involvement https://www.healio.com/rheumatology/polymyositis/news/online/%7Bd7eb5823-f36f-426a-8f79-f34b68264828%7D/fda-grants-orphan-drug-status-to-lenabasum-for-dermatomyositis
bluebird bio’s LentiGlobin gene therapy was granted Accelerated Assessment by the European Medicines Agency for the treatment of Transfusion-Dependent β-Thalassemia https://www.firstwordpharma.com/node/1581407
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), announced in-depth changes to the structure of the office this week in a note to staff. The changes will affect the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications. https://www.biopharmadive.com/news/cder-announces-sweeping-structural-changes-in-letter-from-woodcock-to-staff/528264/
FDA’s Center for Biologics Evaluation and Research (CBER) on Wednesday offered a swath of new draft guidance documents on human gene therapies – offering a look at what it expects from an industry that’s beginning to take off. https://www.raps.org/news-and-articles/news-articles/2018/7/fda-unveils-6-new-draft-guidances-on-gene-therapy?utm
In other news…
Gene therapy biotech Sangamo Therapeutics plans to buy small French company TxCell and its research programs for $84 million. https://www.biopharmadive.com/news/sangamo-buys-txcell-cell-therapy-tech-in-84m-deal/528368/
Faced with a tough market for antibacterial products, Achaogen announced Thursday that it will eliminate 80 positions, which is roughly 28 percent of its staff. https://www.xconomy.com/san-francisco/2018/07/26/achaogen-restructures-slashes-staff-28-ahead-of-antibiotic-launch/?utm
Anima Biotech inked a discovery and development deal with Eli Lilly and Co. that has the potential to exceed $1 billion. https://www.biospace.com/article/anima-biotech-inks-1-billion-plus-deal-with-eli-lilly/?utm
Biogen has bolted on a couple of early-stage drug candidates for neuromuscular diseases via a $535 million deal with California startup AliveGen. https://www.fiercebiotech.com/biotech/biogen-pays-27-5m-upfront-for-two-alivegen-muscle-drugs?mkt
Eli Lilly announced that it will be spinning off Elanco Animal Health as a separate company in order to better focus on their human pharmaceutical business. https://www.biopharmadive.com/news/lilly-divests-elanco-focuses-on-capital-allocation-strategy/528497/
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