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
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