Top Regulatory News Stories – Week Ending June 27, 2019

AMAG Pharmaceuticals announced that the U.S. FDA has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. https://www.amagpharma.com/news/amag-pharmaceuticals-announces-fda-approval-of-vyleesi-bremelanotide-injection-for-acquired-generalized-hypoactive-sexual-desire-disorder-hsdd-in-premenopausal-women/

Alexion’s drug Ultomiris has snagged a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage to vital organs, the drugmaker said Thursday. The FDA’s approval decision date is Oct. 19. https://www.fiercepharma.com/pharma/alexion-s-ultomiris-nabs-fda-fast-track-review-effort-to-back-up-blockbuster-soliris?

Three days after winning Japanese approval for its acute myeloid leukemia drug quizartinib, Daiichi Sankyo is being forced to endure an embarrassing rejection at the hands of the FDA.  https://endpts.com/green-lighted-in-japan-fda-quickly-spurns-daiichi-sankyos-flawed-application-for-aml-drug/

The FDA finalized guidance on the requirements and recommendations for submissions of promotional materials for prescription drugs and biological products, including the specific formats needed.  https://www.raps.org/news-and-articles/news-articles/2019/6/fda-finalizes-guidance-on-advertising-and-promotio?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20|%2021%20June

In other news…

AbbVie Inc. has reached a deal to buy Allergan for about $63 billion, as the two big drugmakers bet a combination will deliver new sources of growth they have struggled to find on their own.  https://www.wsj.com/articles/abbvie-nears-deal-to-buy-allergan-for-more-than-60-billion-11561458504

Bristol-Myers is selling off Otezla in connection with its acquisition of Celgene: https://endpts.com/in-surprise-switch-bristol-myers-is-selling-off-its-blockbuster-otezla-promising-to-complete-celgene-acquisition-just-later/

Conatus Pharmaceuticals said Monday that it would cut its staff by 40 percent and consider a sale or merger after a drug it was testing as a treatment for an increasingly common form of chronic liver disease failed to beat a placebo in a mid-stage clinical trial—the latest letdown in a number of trial failures.  https://xconomy.com/san-diego/2019/06/25/conatus-to-slash-staff-consider-sale-after-nash-trial-failures/?utm

CutisPharma, Inc. announced its acquisition of Silvergate Pharmaceuticals and the unveiling of its new corporate brand for the unified company: Azurity Pharmaceuticals.  https://www.businesswire.com/news/home/20190612005209/en/CutisPharma-Announces-Acquisition-Silvergate-Pharmaceuticals-Change-Azurity

ImmunoGen is set to layoff 220 employees and stop some R&D activities.  https://www.fiercebiotech.com/biotech/immunogen-cuts-deep-to-eke-out-cash-for-mirvetuximab-trial

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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