Ipsen Biopharmaceuticals, Inc.

564 articles with Ipsen Biopharmaceuticals, Inc.

• Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.

  1/27/2023

  Ipsen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva.

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  Ipsen Becomes First to Best Standard of Care in Metastatic PDAC

  1/23/2023

  Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.

• Ipsen Presents Phase III NAPOLI 3 Trial of Onivyde® Regimen Demonstrating Positive Survival Results in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI

  1/20/2023

  Ipsen (Euronext: IPN; ADR: IPSEY) today presented positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde® (irinotecan liposome injection), a long-circulating, liposomal topoisomerase inhibitor, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

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  Ipsen to Acquire Albireo for Rare Disease Portfolio

  1/9/2023

  Ipsen bolsters rare disease portfolio with acquisition of liver disease specialist Albireo.

• Ipsen to Acquire Albireo Accelerating Growth in Rare Disease With Treatments for Several Pediatric Liver Diseases

  1/9/2023

  Ipsen and Albireo announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.

• Ipsen receives Complete Response Letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva

  12/23/2022

  The U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for palovarotene, an investigational treatment for the reduction of new abnormal bone formation in people living with fibrodysplasia ossificans progressiva.

• Exicure, Inc. Announces Termination of AbbVie and Ipsen Collaboration Agreements

  12/14/2022

  Exicure, Inc. an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets, announced the termination of its collaboration agreements with AbbVie, Inc. and Ipsen BioPharm Limited.

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  Ipsen to File sNDA for Pancreatic Cancer Drug Following Positive Phase III Results

  11/9/2022

  Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.

• Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

  11/9/2022

  Ipsen announced the Phase III NAPOLI 3 trial of Onivyde® plus 5 fluorouracil/leucovorin and oxaliplatin met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma and key secondary efficacy outcome of progression-free survival also showed significant improvement over the comparator arm.

• Ipsen Delivers Strong Sales Growth in the First Nine Months of 2022 and Confirms Its Full-year Guidance

  10/27/2022

  Ipsen, a global specialty-driven biopharmaceutical company, presents its sales performance for the year to date and the third quarter of 2022.

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  Ipsen's FOP Saga Continues as FDA Postpones Oct. 31 Adcom

  10/25/2022

  Ipsen hit another stumbling block in its bid for an FOP approval as the FDA's Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
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  FDA Action Alert: Theratechnologies, Alnylam, scPharmaceuticals and More

  10/3/2022

  Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals' Furoscix for heart failure and more. Here's a look at the FDA's October calendar.

• Ipsen Announces Results from Phase III RESILIENT Trial Evaluating Onivyde® in Second-Line Monotherapy for Small Cell Lung Cancer

  8/3/2022

  Ipsen announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival compared to topotecan.

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  Ipsen's Onivyde Flops in Late-Stage Small Cell Lung Cancer Trial

  8/3/2022

  ​​​​​​​Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment. 
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  Ipsen Invests Potential $1.6B to Turbo-Charge Marengo's Path to the Clinic

  8/1/2022

  Marengo Therapeutics and Ipsen have entered into a strategic, multi-year partnership to usher two of Marengo’s precision T cell immuno-oncology candidates into the clinic.

• Ipsen and Marengo Therapeutics Announce Strategic Partnership to Advance Two Precision Immuno-Oncology Candidates From Marengo’s STAR Platform Into the Clinic

  8/1/2022

  Ipsen and Marengo Therapeutics, Inc. announced a strategic partnership to advance two of Marengo’s preclinical STAR platform-generated candidates into the clinic.

• Ipsen Delivers Strong H1 2022 Results and Upgrades Its Full-Year Guidance

  7/28/2022

  Ipsen, a global specialty-driven biopharmaceutical company, presents its financial results for the first half of 2022: H1 2022 financial results Strong sales growth of 10.5% at CER1 Core operating margin of 39.6%; IFRS operating margin of 35.7% Core consolidated net profit of €420m, growing by 19.9%.

• Ipsen Announces U.S. FDA Priority Review for palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission

  6/29/2022

  Ipsen announced that the U.S. Food and Drug Administration has accepted for Priority Review its resubmitted New Drug Application for investigational palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder.

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  Ipsen Snags Epizyme and Cancer Portfolio for a Cool $247M

  6/27/2022

  Ipsen announced it is acquiring the company and its cancer drugs, including Tazverik, which were approved for two different indications by the FDA in 2020.

• Ipsen to acquire Epizyme, expanding its portfolio in oncology

  6/27/2022

  Ipsen and Epizyme announced that they have entered into a definitive merger agreement under which Ipsen will acquire Epizyme.