Karyopharm Therapeutics announced that the U.S. FDA has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). https://www.globenewswire.com/news-release/2019/07/03/1878060/0/en/Karyopharm-Announces-FDA-Approval-of-XPOVIO-selinexor-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html
Alexion’s Soliris received FDA approval for an additional indication last week. The drug is now approved to treat neuromyelitis optica spectrum disorder, a rare autoimmune condition characterized by sudden attacks on the central nervous system. https://endpts.com/alexions-cash-cow-soliris-just-got-fatter-as-fda-greenlights-another-blockbuster-indication/
The FDA has put Unum Therapeutics’ phase 1 ACTR087-Rituxan trial on clinical hold for the second time after a patient experienced grade 3 and 4 adverse events including neurotoxicity and respiratory distress. https://www.fiercebiotech.com/biotech/fda-puts-unum-t-cell-therapy-trial-hold-after-adverse-events
Amgen and UCB disclosed that the EMA has adopted a negative opinion on their osteoporosis drug, romosozumab. https://endpts.com/amgen-ucb-hit-another-evenity-hurdle-as-european-regulators-fail-to-back-the-osteoporosis-drug/
Zogenix will apply for FDA approval of its Dravet syndrome drug Fintepla by the end of September, the company said after meeting with regulators. https://www.biopharmadive.com/news/zogenix-boosted-on-fda-about-face-for-seizure-drug-application/557817/
Iovance’s promising data snapshot detailing the potential of its cervical cancer drug at ASCO has convinced the FDA to accelerate its path to approval. https://endpts.com/emboldened-by-asco-data-fda-etches-speedy-approval-path-for-iovances-cervical-cancer-therapy/
Biomarin reported that their recent talks with the FDA and the EMA convinced execs to make a leap for an accelerated approval of their gene therapy hemophilia program with data on just a handful of patients. https://endpts.com/billions-on-the-line-biomarin-bustles-past-enthused-rival-planning-to-launch-worlds-first-hemophilia-a-gene-therapy/
Prevail Therapeutics announced that the FDA has granted Fast Track Designation for the Company’s lead gene therapy program, PR001, for the treatment of Parkinson’s disease. http://www.firstwordpharma.com/node/1651814#axzz5tBfOVa8k
Glenmark Pharma said the FDA has issued a Complete Response Letter regarding the new drug application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray. https://www.drugs.com/nda/ryaltris_190625.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Issues+Complete+Response+Letter+for+Ryaltris+NDA
In other news…
Acer Therapeutics is slashing its staff by more than half and halting work on its lead drug candidate for a tissue disorder after an FDA rejection: https://www.bizjournals.com/boston/news/2019/07/05/newton-drugmaker-acer-cuts-more-than-two-dozen.html
ADC Therapeutics has raised an addition $303 million to fund their first planned BLA for their lead antibody-drug conjugate next year. https://endpts.com/adc-therapeutics-has-raised-550m-plus-in-its-quest-for-their-first-bla-and-heres-why-thats-important/
Amneal Pharmaceuticals will restructure its business and cut costs in a plan aimed at saving the company about $50 million a year, it said Wednesday. https://www.biopharmadive.com/news/amneal-to-restructure-slashing-2019-earnings-estimate/558480/
After a big downsizing in 2018, Teva is now adding to its US R&D center in Pennsylvania: https://endpts.com/after-a-radical-downsizing-teva-beefs-up-us-r-tiaki-recruits-suzanne-bruhn-for-the-helm/
Biogen announced that it has completed its acquisition of Nightstar Therapeutics a clinical-stage gene therapy company, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. https://www.globenewswire.com/news-release/2019/06/07/1865784/0/en/Biogen-Completes-Acquisition-of-Nightstar-Therapeutics-for-Approximately-800-Million.html
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