Allergan and Pfizer Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Allergan and Pfizer.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday March 8, 2017 to Tuesday March 14, 2017.

FDA Accepts Allergan’s Label Submission for Anti-Psychotic Drug
The US Food and Drug Administration (FDA) has accepted for filing Allergan’s supplemental new drug application for Vraylar (cariprazine), an anti-psychotic drug, seeking an addition to the current product label of new clinical data evaluating the drug’s maintenance of efficacy in adults with schizophrenia.

Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar in the US for the acute treatment of manic or mixed episodes of bipolar I disorder and for treating schizophrenia in adults. The drug was discovered and co-developed by Gedeon Richter, a Budapest, Hungary-headquartered biopharmaceutical company, and is licensed to Actavis, now Allergan, in the US and Canada.

Source: Allergan

FDA Clears Pfizer’s IND for CAR-T Leukemia Drug
Pfizer and its partner, Servier, a Suresnes, France-headquartered pharmaceutical company, have been granted clearance by the US Food and Drug Administration for an investigational new drug filing for a leukemia drug candidate. The clearance allows Pfizer and its partners to proceed in the US with the clinical development of UCART19, an allogeneic, gene-edited, chimeric antigen receptor T-cell (CAR T) therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.

Servier is sponsoring a Phase I study after acquiring exclusive rights from Cellectis, a France-based biopharmaceutical company, in November 2015 for UCART19, which is now being co-developed by Servier and Pfizer. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the US, while Servier retains exclusive rights for all other countries.

Source: Pfizer 

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