Top Regulatory News Stories – Week Ending December 15, 2017

Hi folks.  Here are the top regulatory news stories for this week:

Pfizer Inc. announced today that the FDA has approved IXIFI™ a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product.  https://www.firstwordpharma.com/node/1529996#axzz51FIjJ9GS

The FDA approved Sanofi’s rapid-acting insulin analog Admelog https://www.morningstar.com/news/pr-news-wire/PRNews_20171211NY67089/fda-approves-sanofis-admelog-insulin-lispro-injection.html

Omeros Corporation announced that the FDA approved its sNDA for OMIDRIA (phenylephrine and ketorolac intraocular solution) to include use in pediatric patients (ages birth through 17 years old). https://www.firstwordpharma.com/node/1529448

Eli Lilly announced that the US FDA has accepted their BLA to review galcanezumab for the prevention of migraine in adults. https://www.biospace.com/article/releases/fda-accepts-bla-to-review-eli-lilly-s-galcanezumab-for-the-prevention-of-migraine-in-adults/?s=85

MeiraGTx announced that the FDA has granted rare pediatric disease designation to their gene therapy product candidate AAV2/5-OPTIRPE65 (A001) for the treatment of patients with Leber’s Congenital Amaurosis https://www.firstwordpharma.com/node/1528304

The FDA accepted Indivior’s NDA for their new schizophrenia drug, risperidone: https://www.reuters.com/article/us-indivior-fda/u-s-fda-accepts-application-for-indiviors-new-schizophrenia-drug-idUSKBN1E60Q0

The FDA on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. http://www.raps.org/Regulatory-Focus/News/2017/12/11/29018/FDA-Finalizes-Guidance-on-Promotional-Drug-Labeling-and-Ads/?utm

Concerned about the veracity of some pharmaceutical marketing, the Food and Drug Administration plans to study the extent to which doctors and consumers can detect deceptive ads.  https://www.statnews.com/pharmalot/2017/12/12/fda-bad-ads-consumers/?utm

In other news…

Teva announced Thursday that it will cut 14 000 jobs, or around 25 percent of its global workforce, over the next two years as part of a restructuring plan designed to reduce costs by $3 billion. https://www.firstwordpharma.com/node/1530082?tsid=17#axzz51FIjJ9GS

Gilead Sciences and its cell therapy subsidiary Kite announced today that they have entered into a definitive agreement under which they have agreed to acquire Cell Design Labs https://www.businesswire.com/news/home/20171207006250/en/Gilead-Sciences-Kite-Acquire-Cell-Design-Labs

Sucampo Pharmaceuticals Iis reviewing options including a sale of the business after receiving takeover interest https://www.bloomberg.com/news/articles/2017-12-07/sucampo-is-said-to-weigh-sale-after-receiving-takeover-interest

Teva Pharmaceutical is considering cutting as many as 10,000 jobs as new Chief Executive Officer Kare Schultz seeks to pare costs https://www.bloomberg.com/news/articles/2017-12-08/teva-said-to-weigh-cutting-up-to-10-000-jobs-to-pare-expenses?

Dart NeuroScience a developer of drugs to improve memory, is closing its operations in San Diego and permanently laying off about 265 employees, according to a notice filed with the state. http://www.sandiegouniontribune.com/business/biotech/sd-me-biotech-layoffs-20171208-story.html

Vertex has licensed a blood disorder gene therapy from CRISPR Therapeutics targeting beta-thalassemia and sickle cell disease. https://www.fiercebiotech.com/biotech/vertex-licenses-blood-disorder-gene-therapy-from-crispr-therapeutics?

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