FDA clears expanded label for Ipsen's Somatuline Depot
Seeking Alpha - at Seeking Alpha - Wed Dec 17, 6:56AM CST
Ipsen's Somatuline(R) Depot(R) is the First Therapy Approved by the FDA in the United States for the Treatment of Patients with Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Business Wire - Tue Dec 16, 4:00PM CST
--US organization ready for launch in Q1 2015
Ipsen Announces the FDA Approval of Somatuline(R) Depot(R) (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors
Business Wire - Tue Dec 16, 3:45PM CST
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that Somatuline(R) Depot(R) (lanreotide) Injection 120 mg (referred to as Somatuline(R)) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival (PFS).
Francois Garnier Appointed Executive Vice President, General Counsel of Ipsen
Business Wire - Tue Dec 16, 11:00AM CST
Regulatory News:
FDA clears expanded label for Novartis' Signifor
Seeking Alpha - at Seeking Alpha - Tue Dec 16, 6:10AM CST
NVS: 93.91 (+0.66)
Ipsen Announces That the International Breast Cancer Study Group (IBCSG) Presented Phase 3 Results Evaluating the Use of Ovarian Suppression to Adjuvant Treatment with Tamoxifen
Business Wire - Fri Dec 12, 12:00AM CST
--Ovarian suppression was obtained entirely by monthly injections of triptorelin over 5 years for 81% of patients
Ipsen Biopharmaceuticals, Inc. Announces FDA Acceptance of Filing for Dysport(R) (abobotulinumtoxinA) in the Treatment of Upper Limb Spasticity in Adult Patients
Business Wire - Mon Dec 01, 9:31AM CST
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext:IPN; ADR:IPSEY), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Dysport(R) (abobotulinumtoxinA) for the treatment of upper limb spasticity in adult patients.
FDA agrees to review Ipsen Dysport label expansion application
Seeking Alpha - at Seeking Alpha - Fri Nov 28, 7:30AM CST
Ipsen Announces FDA Acceptance of Filing for Dysport(R) in the Treatment of Upper Limb Spasticity in Adult Patients
Business Wire - Fri Nov 28, 12:00AM CST
Regulatory News:
Ipsen Biopharmaceuticals, Inc. Announces IPSEN CARES(TM), An Enhanced Patient Support Program
Business Wire - Mon Nov 24, 9:42AM CST
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced the implementation of IPSEN CARES(TM) (Coverage, Access, Reimbursement, & Education Support). Ensuring patients, providers and caregivers have the resources needed to help access the Ipsen medications that are critical to managing their conditions, IPSEN CARES is staffed Monday to Friday by experts who can assist with a broad range of medical, educational, logistical and coverage information regarding Ipsen medicines, including Increlex(R) (mecasermin), Somatuline(R) Depot(R) (lanreotide), and Dysport(R) (abobotulinumtoxinA).
Lexicon Pharmaceuticals Fights On
Stephen Simpson, CFA - at Seeking Alpha - Fri Nov 21, 11:09AM CST
LXRX: 0.90 (+0.02)
Ipsen and CNRS Create the "Archi-Pex" Joint Research and Innovation Lab, in Collaboration with the University of Rennes 1 and CEA
Business Wire - Thu Nov 20, 11:00AM CST
--Five-year public-private research partnership, built on 15 years of collaboration
Ipsen and the Salk Institute renew their agreement for discovery research in medical sciences
Business Wire - Tue Nov 18, 12:00AM CST
--Ipsen to support innovative Salk investigations into biology for another three years
Ipsen Announces FDA Approval of a New Delivery Device for Somatuline(R) Depot(R) (lanreotide) Injection
Business Wire - Thu Nov 06, 9:06AM CST
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that the U.S. Food and Drug Administration (FDA) has approved a new device to deliver Somatuline(R) Depot(R) (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.
Otonomy Obtains Rights to Gacyclidine Data From Ipsen to Support Development of OTO-311 as a Treatment for Tinnitus
GlobeNewswire - Thu Nov 06, 12:00AM CST
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, and Ipsen (Euronext:IPN) (ADR:IPSEY), a global specialty-driven pharmaceutical company, today announced that they have entered into an exclusive licensing agreement enabling Otonomy to utilize Ipsen's gacyclidine data in the development and registration of OTO-311. OTO-311 is Otonomy's sustained-exposure formulation of gacyclidine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, in development for the treatment of tinnitus.
OTIC: 32.26 (+0.65), IPN: 29.31 (+0.24)
Otonomy obtains rights to gacyclidine data from Ipsen to support development of OTO-311 as a treatment for tinnitus
Business Wire - Thu Nov 06, 12:00AM CST
Regulatory News:
OTIC: 32.26 (+0.65)
Ipsen Biopharmaceuticals, Inc. Announces Hire of Donald Pearl as Vice President of Neurology
Business Wire - Wed Nov 05, 8:37AM CST
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that Donald Pearl has joined the company as Vice President of Neurology. Mr. Pearl will work closely with senior leadership to build out the neurology commercial structure in the U.S. as Ipsen builds upon its 20 years of clinical experience with Dysport(R) (abobotulinumtoxinA) and pursues a comprehensive and ambitious neurotoxin clinical study program.
AGN: 210.12 (+0.95)
Ipsen: sales in the 3rd quarter and first nine months of 2014
Business Wire - Wed Oct 29, 1:00AM CDT
--Dysport(R) up 18.9%(1), helped by exceptional orders from Group partner in aesthetic medicine
Lexicon and Ipsen enter into ex-North America/Japan licensing and commercialization agreement for telotristat etiprate
Business Wire - Wed Oct 22, 12:07AM CDT
--Lexicon to potentially receive $145 million in upfront and milestone payments, plus royalties
LXRX: 0.90 (+0.02)