Top Regulatory News Stories – Week Ending July 12, 2019

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

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/

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