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.

The FDA approved Sanofi’s rapid-acting insulin analog Admelog

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).

Eli Lilly announced that the US FDA has accepted their BLA to review galcanezumab for the prevention of migraine in adults.

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

The FDA accepted Indivior’s NDA for their new schizophrenia drug, risperidone:

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.

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.

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.

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

Sucampo Pharmaceuticals Iis reviewing options including a sale of the business 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

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.

Vertex has licensed a blood disorder gene therapy from CRISPR Therapeutics targeting beta-thalassemia and sickle cell disease.

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