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 »

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 »

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 »

ABBVIE: AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. Read More »

ABBVIE: Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). Read More »