This week the FDA approved two new products and announced a new pilot program for orphan drug designations. Celgene received a Refusal to File letter and Allergan’s PDUFA date was delayed. And the EMA provided more details regarding their new premises in Amsterdam. Here are the top regulatory news stories for this week:
KemPharm announced that the U.S. FDA approved its NDA for opioid painkiller Apadaz for the short-term management of acute pain https://globenewswire.com/news-release/2018/02/23/1386840/0/en/KemPharm-Announces-FDA-Approval-of-Apadaz-benzhydrocodone-and-acetaminophen-for-the-Short-Term-Management-of-Acute-Pain.html
Sorrento Therapeutics reported that the FDA has approved ZTlido, its non-opioid painkiller patch for nerve pain related to shingles, which it plans to launch later this year. https://www.reuters.com/article/us-sorrento-thera-fda/fda-approves-sorrentos-non-opioid-painkiller-patch-shares-jump-idUSKCN1GC2XE
Eli Lilly received FDA approval for expanded use of cancer treatment Verzenio. This is the third approved indication for Verzenio in the past five months: https://www.biospace.com/article/eli-lilly-s-verzenio-picks-up-third-approved-indication/?utm
Jazz Pharmaceuticals announced that the FDA has accepted for filing with standard review the company’s NDA seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. http://firstwordpharma.com/node/1546142?tsid=28®ion_id=4#axzz58bbfV04Z
Celgene received a “Refusal to File” letter from the FDA for its NDA for the multiple sclerosis drug ozanimod. Celgene’s announcement was short on details but it appears that the nonclinical and clinical pharmacology sections in the NDA were insufficient for the agency to move ahead in the approval process. https://www.biopharmadive.com/news/celgenes-ozanimod-hit-with-refusal-to-file-in-latest-setback/518055/
Allergan announced that the FDA user fee action date for ulipristal acetate has been pushed to August 2018 due to potential liver injury: https://www.biopharmadive.com/news/allergans-esmya-delay-fda-liver-injury-europe/518182/
The FDA has granted Shire’s BLA for lanadelumab priority review. The compound is being investigated for the prevention in angioedema attacks in patients 12 years and older that have hereditary angioedema. https://www.biospace.com/article/fda-gives-shire-s-lanadelumab-priority-review/?utm
CorMedix Inc. announced that the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma. https://www.firstwordpharma.com/node/1545053#axzz58KAS1vB3
Polaryx Therapeutics received orphan drug designation from the EMA for the treatment of neuronal ceroid lipofuscinosis with PLX-200 https://www.firstwordpharma.com/node/1545066#axzz58KAS1vB3
According to the Health Research Institute at PricewaterhouseCoopers, the rate of new regulatory actions taken by the Food and Drug Administration under President Trump were only a fraction of the number of actions taken during the Obama administration and dropped to the lowest level of any time in the past 20 years. https://www.statnews.com/pharmalot/2018/02/28/trump-fda-regulations-trickle/
With more than 700 orphan designation requests last year, the US FDA announced a new pilot program to make the request process more efficient. https://www.raps.org/news-and-articles/news-articles/2018/2/fda-to-launch-new-pilot-program-for-orphan-designa?utm
The EMA is planning to move their headquarters to Amsterdam by November 2019: https://www.raps.org/news-and-articles/news-articles/2018/2/ema%E2%80%99s-new-amsterdam-hq-to-be-ready-by-november-201
In other news…
Fresenius Kabi’s pending acquisition of Akorn has been threatened by allegations that Akorn’s product development activities breached data integrity requirements set by the FDA. https://www.biopharmadive.com/news/akorn-tanks-as-puzzling-probe-threatens-fresenius-deal/517969/
Mylan signed a global collaboration and license deal with Revance Therapeutics to develop and market a biosimilar to Botox (onabotulinumtoxinA). https://www.biospace.com/article/mylan-teams-up-with-revance-therapeutics-to-develop-botox-biosimilar/?utm
Gene therapy startup Generation Bio raised $100 million in second-round financing just over a month after its $25 million series A. https://www.biospace.com/article/generation-bio-raises-100-million-series-b-to-finance-non-viral-gene-therapy-program/
Novartis inked a collaboration deal Pear Therapeutics to develop prescription digital therapeutics for schizophrenia and multiple sclerosis. The deal will combine Novartis’ neurological, clinical development and commercialization expertise with Pear’s experience in prescription digital therapeutic design. https://www.biospace.com/article/novartis-and-pear-therapeutics-launch-collaboration-focused-on-schizophrenia-and-multiple-sclerosis/?utm
Biogen and AbbVie are yanking MS drug Zinbryta off the market in the wake of encephalitis cases: https://endpts.com/biogen-abbvie-yank-ms-drug-zinbryta-off-the-market-in-the-wake-of-encephalitis-cases/?utm
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