I am posting my regulatory news blog early since I will be out of the office tomorrow. Here are the top regulatory news stories this week:
The U.S. FDA approved Mylan’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin. This is the eighth biosimilar to be approved by the FDA: https://www.reuters.com/article/us-mylan-nl-fda/fda-oks-mylans-biosimilar-of-roche-cancer-drug-herceptin-idUSKBN1DV5BI
Sunovion received FDA approval for Lonhala™ Magnair™ inhalation solution to treat COPD http://www.businesswire.com/news/home/20171205006502/en/Sunovion-Receives-FDA-Approval-Lonhala%E2%84%A2-Magnair%E2%84%A2-Inhalation
The FDA approved Novo Nordisk’s diabetes drug Ozempic (semaglutide), a once-weekly injection: https://www.reuters.com/article/us-novo-nordisk-diabetes-fda/fda-approves-novo-nordisk-diabetes-drug-ozempic-idUSKBN1DZ2O9
FDA approved Indivior’s once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm
Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis). Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis: https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-us-fda-approval-for-the-treatment-of-active-psoriatic-arthritis-300565484.html
INSYS Therapeutics announced that its NDA for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the FDA and a PDUFA date has been set for July 28, 2018: https://www.streetinsider.com/Corporate+News/Insys+Therapeutics+%28INSY%29+Announces+FDA+Drug+Application+for+Buprenorphine+Sublingual+Spray/13574506.html
Amphivena Therapeutics announced that it has received Orphan Drug Designation from the FDA for its lead compound AMV564 for the treatment ofAML. https://www.firstwordpharma.com/node/1526036
Ovid Therapeutics announced that the FDA has granted orphan drug designation to TAK-935/OV935 for the treatment of Dravet syndrome https://www.firstwordpharma.com/node/1527557
The FDA granted a fast-track review Clovis’s ovarian cancer drug, rucaparib, with a decision expected by April 6, 2018: https://www.bizjournals.com/denver/news/2017/12/05/clovis-oncologygets-fda-fast-tracked-review-date.html
According to a new presentation by CDER’s Office of New Drugs, active INDs hit 7,020 in November, a 14 year high: https://endpts.com/cancer-rd-tips-the-scales-at-the-fda-as-active-inds-climb-to-record-high/
Pentagon officials wanted to fast-track unapproved drugs and medical devices for emergency battlefield use. However, after strong pushback from lawmakers, advocates, and FDA Commissioner Scott Gottlieb, the FDA is still the only one with emergency drug approval authority. https://www.healthline.com/health-news/fda-pentagon-battle-fast-tracking-drugs#1
In other news…
Depomed Inc. announced it will cut staff by 40% to about 70 employees, and that they plan to move their office out of the Bay Area: https://www.biospace.com/article/unique-bay-area-s-depomed-pink-slips-40-percent-of-staff-and-looks-to-move-hq/?utm
Avanir Pharmaceuticals terminated about 11 percent of its sales force after CNN filed a report showing how the company paid 500 prescribers about $14 million over three years for prescribers to tout the benefits of its leading CNS drug Nuedexta. https://www.biospace.com/article/unique-investigation-leads-socal-s-avanir-to-quietly-lay-off-73-employees/?utm
Bluebird Bio has entered into a $16M partnership agreement with TC BioPharm to leverage their tumor invading tech platform: https://endpts.com/taking-on-on-gamma-delta-t-cells-bluebird-pays-16m-for-tc-biopharms-tumor-invading-tech-platform/
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