On Monday BioMarin received FDA approval for Palynziq to treat a rare disease known as phenylketonuria. https://seekingalpha.com/article/4177692-biomarin-keeps-fda-approval-train-rolling
On Wednesday the FDA approved TherapeuticsMD’s IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. This comes a year after the FDA issued a CRL rejection based on safety concerns. https://endpts.com/fda-executes-a-180-on-therapeuticsmd-therapy-handing-it-an-ok-and-stoking-concerns-about-political-influence/?utm
Recro Pharma received a Complete Response letter from the FDA regarding its NDA for IV meloxicam: https://ir.recropharma.com/press-releases/detail/114/recro-pharma-receives-complete-response-letter-from-the-fda
The FDA has slapped a clinical hold on the IND filed by Vertex and CRISPR Therapeutics on a new gene therapy for sickle cell disease. https://endpts.com/fda-slaps-a-clinical-hold-on-sickle-cell-ind-filed-by-vertex-and-crispr-therapeutics/?utm
Loxo Oncology and Bayer AG said on Tuesday that the FDA granted priority review to their cancer drug, larotrectinib, and would decide on the marketing application by Nov. 26. https://www.reuters.com/article/us-loxo-oncology-cancer/loxo-bayer-cancer-drug-gets-priority-review-from-fda-idUSKCN1IU1C6?feedType=nl&feedName=healthNews&utm_source=Sailthru&utm
The FDA has accepted Eisai’s sNDA for Priority Review for its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use for the treatment of partial-onset seizures with or without secondarily generalized seizures in pediatric patients. https://www.pharmpro.com/news/2018/05/eisai-receives-fda-priority-review-designation-fycompa
Nektar Therapeutics announced that it had submitted a NDA to the FDA for NKTR-181, a new molecular entity, a mu-opioid agonist for pain relief. https://www.biospace.com/article/nektar-therapeutics-big-week-syndax-cancer-collaboration-and-new-opioid-submission/?utm
The FDA has awarded priority review designation to Sage Therapeutics’ postpartum depression drug brexanolone. Securing the status positions Sage to receive a decision from the FDA by the end of the year. https://www.fiercebiotech.com/biotech/sage-postpartum-depression-drug-gets-priority-review-at-fda-teeing-up-2018-approval
Clinical Research Consultants snagged FDA approval for the first stand-alone prosthetic iris implant. https://www.raps.org/news-and-articles/news-articles/2018/5/fda-approves-first-artificial-iris-implant?feed=Regulatory-Focus
The FDA on Wednesday released draft guidance to help biopharma companies address the precision of blood pressure measurements in the assessment of the effects of a drug in development. https://www.raps.org/news-and-articles/news-articles/2018/5/fda-drafts-guidance-to-help-address-blood-pressure?utm
In other news…
Prothena Biosciences announced a 57% cut in their workforce after its lead asset missed its primary and secondary endpoints: https://www.fiercebiotech.com/biotech/after-al-amyloidosis-flop-prothena-slashes-workforce-by-57
Karyopharm Therapeutics and Antengene Corporation announced their entry into an exclusive license agreement for the development and commercialization of four of Karyopharm’s novel, oral drug candidates. http://www.firstwordpharma.com/node/1568189#axzz5GtoE8jrV
San Diego’s Pfenex has raised about $39.4 million from a public offering that will be used to launch its new osteoporosis drug. http://www.sandiegouniontribune.com/business/biotech/sd-me-pfenex-offering-closes-20180529-story.html
San Francisco’s Kezar Life Sciences and Chicago’s Xeris Pharmaceuticals both filed intentions for initial public offerings: https://endpts.com/kezar-and-xeris-file-for-ipos-joining-mays-march-to-the-public-markets/?utm
Eidos Therapeutics and Avrobio also filed for IPOs this week: https://endpts.com/eidos-avrobio-shoot-for-201m-as-biotech-ipos-continue-to-roll-forward-on-nasdaq/?utm
Luye Pharma Group announced their acquisition of AstraZeneca’s core CNS products – Seroquel and Seroquel XR. http://www.firstwordpharma.com/node/1568233#axzz5GtoE8jrV
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/