ABBVIE: AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Read More »

ASTELLAS PHARMA US, INC.: Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program

Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1). Read More »

ABBVIE: AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for venetoclax in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Read More »

ABBVIE: AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced an update on a Phase 3 study (DBL3001) of ibrutinib (IMBRUVICA®) in untreated (treatment-naïve) diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL). Read More »

ABBVIE: IMBRUVICA® (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) as a new treatment option for Waldenström's macroglobulinemia (WM), a rare and incurable form of blood cancer. Read More »

ABBVIE: AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase 3 MURANO trial of venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, in combination with rituximab (VenR) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Read More »

ALLERGAN, INC: Allergan Announces Positive Topline Phase 3 Clinical Data for Bimatoprost SR (Sustained-Release) Implant for IOP Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension

Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced the release of new topline clinical trial data on Bimatoprost SR, the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read More »

ABBVIE: AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy Read More »

ASTELLAS PHARMA US, INC.: Astellas and Seattle Genetics Present at ASCO 2018 on Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Cancer Previously Treated with Checkpoint Inhibitor Therapy

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq: SGEN) today announced the presentation of updated phase 1 data of enfortumab vedotin, an investigational antibody-drug conjugate (ADC), at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago. Read More »

TAKEDA PHARMACEUTICAL COMPANY: Takeda Highlights Favorable Safety Profile of Entyvio® (vedolizumab) Through Comparative Real-World Data Versus TNFα-Antagonist Therapy in Ulcerative Colitis and Crohn’s Disease

Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced a new analysis of real-world data comparing the safety data of the gut-selective biologic Entyvio® (vedolizumab) and tumor necrosis factor-alpha (TNFα)-antagonist therapy. Read More »

ABBVIE: Phase 3 IMBRUVICA® (ibrutinib) Data Suggest Improved Treatment Outcomes in Waldenström's Macroglobulinemia (WM), a Rare Form of Blood Cancer, in Combination with Rituximab versus Rituximab Alone

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced findings from an interim analysis of the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) plus RITUXAN® (rituximab) in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma (NHL). Read More »

ASTELLAS PHARMA US, INC.: U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved tes Read More »

MYLAN INC: Mylan Statement on Supply of EpiPen® (epinephrine injection, USP) Auto-Injectors from Meridian Medical Technologies, a Pfizer company

The U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available. Read More »

TAKEDA PHARMACEUTICAL COMPANY: TRINTELLIX® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD)

Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). Read More »

ASTELLAS PHARMA US, INC.: Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia

Astellas Pharma Inc. announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). Read More »