This was a big week with the approval of three new molecular entities by the FDA while Evolus received a complete response letter. Here is my recap of the top regulatory news stories this week:
The FDA approved Amgen’s Aimovig (erenumab-aooe) for the preventive treatment of migraines in adults: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm
The FDA approved Pfizer’s Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm
US WorldMeds’ Lucemyra (lofexidine hydrochloride) became the first non-opioid treatment for the management of opioid withdrawal symptoms among adults to receive FDA approval. https://www.raps.org/news-and-articles/news-articles/2018/5/us-worldmeds-wins-fda-nod-for-first-non-opioid-to?utm
Evolus announced that the FDA has handed the company a complete response letter for DWP-450 (prabotulinumtoxinA), a potential rival to Botox. Evolus’s management says the rejection has nothing to do with data, statistics, safety or pharmacology of their product, but rather was due to manufacturing issues. https://endpts.com/fda-stiff-arms-evolus-rival-to-allergans-blockbuster-botox-but-execs-promise-a-snap-response/?utm
Aerie Pharmaceuticals announced the submission of its NDA to the FDA for Roclatan, an eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. https://www.businesswire.com/news/home/20180515005050/en/Aerie-Pharmaceuticals-Submits-New-Drug-Application-U.S.
The FDA on Monday proposed amending its product classification rules for combination products to help clarify the scope of the regulations and better align the regulations with recent legislation. https://www.raps.org/news-and-articles/news-articles/2018/5/fda-proposes-changes-to-classification-rules-for-c?utm
The FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. Details of the OND reorganization will be rolled out this summer. https://www.biocentury.com/biocentury/politics-policy-law/2018-05-11/fda-reorganizing-office-new-drugs-stay-ahead-drug-
A report from the Centre for Innovation in Regulatory Science (CIRS) released this month finds that the FDA has reclaimed its position as the fastest major regulator for approving new drugs and biologics. https://www.raps.org/news-and-articles/news-articles/2018/5/fda-faster-than-global-peers-at-approving-new-drug?utm
On Thursday the FDA called out a list of branded companies that may be trying to delay competition from a generic competitor by blocking access to product samples: https://www.statnews.com/2018/05/17/fda-shames-drug-companies-generics-access/
In other news…
Eli Lilly’s oncology deal spree is continuing this morning with a $576 million deal to buy out a Montreal-based startup AurKa Pharma and reel back in an early-stage cancer drug for its pipeline. https://endpts.com/eli-lillys-oncology-rd-spree-continues-with-576m-deal-to-buy-a-startup-and-reel-back-aurora-a-drug/?utm
Faced with disappointing results from its latest preclinical program, aTyr Pharma is cutting the development short and letting go around 30% of its staff. https://endpts.com/troubled-atyr-axes-30-of-its-staff-as-it-wipes-a-preclinical-slate-clean/?utm
German biotech firm Medigene has expanded their collaboration agreement with Bluebird Bio, increasing the pool of potential milestone payments to $1.5 billion. https://www.reuters.com/article/us-medigene-bluebird-bio/medigene-in-for-up-to-1-5-billion-under-broader-pact-with-bluebird-bio-idUSKCN1IF0O8
Surface Pharmaceuticals has raise up about $20 million in a sale of series A preferred stock, completing its spinoff from Imprimis Pharmaceuticals into a separately financed and managed company. https://www.fiercebiotech.com/biotech/imprimis-offshoot-raises-20-million-to-develop-dry-eye-meds?mkt
Eleven Biotherapeutics announced that the company is changing its name to Sesen Bio, Inc. https://www.businesswire.com/news/home/20180516005210/en/Eleven-Biotherapeutics-Announces-Corporate-Change-Sesen-Bio
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/