Top Regulatory News Stories – Week Ending April 26, 2019

Hi folks!  I haven’t done my regulatory news blog in a few months but I’m hoping to make it a regular thing again.  Here are the top regulatory news stories this week:

On Tuesday the FDA had approved Abbvie’s Skyrizi (risankizumab-rzaa) for severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.  https://www.biospace.com/article/fda-gives-abbvie-s-skyrizi-a-thumbs-up-for-plaque-psoriasis/

On April 12 the FDA approved Janssen’s Balversa (erdafitinib) for the treatment of Metastatic Urothelial Carcinoma:  https://www.biospace.com/article/fda-approves-janssen-s-balversa-first-targeted-therapy-for-metastatic-urothelial-carcinoma/

On April 9th the FDA approved Amgen’s EVENITY (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture:  https://www.amgen.com/media/news-releases/2019/04/fda-approves-evenity-romosozumabaqqg-for-the-treatment-of-osteoporosis-in-postmenopausal-women-at-high-risk-for-fracture/

Knopp Biosciences announced that the U.S. FDA has granted Orphan Drug Designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES). https://www.businesswire.com/news/home/20190424005324/en/Knopp-Biosciences-Receives-FDA-Orphan-Drug-Designation/?

Albireo Pharma announced that its IND has cleared the required 30 day review by the FDA and is in effect for a Phase 2 clinical trial of elobixibat for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).  https://www.drugs.com/clinical_trials/albireo-announces-fda-clearance-ind-commence-phase-2-trial-elobixibat-nafld-nash-18127.html

More NDAs and BLAs were filed in the first quarter of 2019 than in any quarter in 2018.  A recent report shows that 53 NDAs and 4 BLAs were filed in Q1 of this year:  https://www.raps.org/news-and-articles/news-articles/2019/4/more-ndas-blas-filed-in-q1-2019-than-any-quarter

So far this year the FDA has approved eight novel drugs and you can see the full list here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm629491.htm

In other news…

Shares in Mustang Bio soared after an experimental gene therapy proved successful in treating children with a debilitating condition often termed “bubble boy” disease.  https://www.biopharmadive.com/news/mustang-bio-shares-bubble-boy-gene-therapy-cure/553037/

Proteon Therapeutics is exploring a sale after its second drug failure: https://www.globenewswire.com/news-release/2019/04/15/1804324/0/en/Proteon-Therapeutics-Announces-Review-of-Potential-Strategic-Transactions.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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