Specialty Pharma Journal Specialty, Precision & Technology
NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for …
Tag Archives: abbvie
December, 2018
-
6 December
AbbVie Halts Enrollment of Phase 3 Trial Evaluating Rova-T as Second-Line Therapy for Advanced Small-Cell Lung Cancer
NORTH CHICAGO, Ill., Dec. 5, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping …
-
5 December
Imbruvica Combination Regimen Significantly Improved Survival in Phase 3 Trial in Previously Untreated and Younger CLL Patients
NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today shared results from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), National Cancer Institute (NCI)-sponsored, Phase 3 study (E1912) evaluating IMBRUVICA® (ibrutinib) plus rituximab versus the current National Comprehensive Cancer Network (NCCN) guidelines Category 1 treatment of fludarabine, cyclophosphamide …
November, 2018
-
21 November
FDA Grants Accelerated Approval to Venclexta for Newly-Diagnosed Acute Myeloid Leukemia or Patients Ineligible for Intensive Induction Chemo
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people …
-
15 November
Mission Therapeutics and AbbVie Sign DUBs Collaboration in Alzheimer’s and Parkinson’s Disease
CAMBRIDGE, England and NORTH CHICAGO, Ill.–(BUSINESS WIRE)–Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively targeting deubiquitylating enzymes (DUBs) and AbbVie (“AbbVie”)(NYSE: ABBV), a research-based global biopharmaceutical company, today announced a collaboration in the research and preclinical development of specified DUB inhibitors for the treatment of Alzheimer’s Disease …
-
14 November
AbbVie’s Mavyret Shows High Virologic Cure Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis
NORTH CHICAGO, Ill., Nov. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) …
-
1 November
AbbVie’s Venetoclax Demonstrates Positive Results in Phase 3 Study as First-Line Therapy in Patients with Chronic Lymphocytic Leukemia
NORTH CHICAGO, Ill., Oct. 31, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from CLL14, a Phase 3, randomized clinical trial evaluating venetoclax plus obinutuzumab versus obinutuzumab plus chlorambucil, a standard of care, in patients with chronic lymphocytic leukemia (CLL) and coexisting medical conditions who …
October, 2018
-
25 October
AbbVie Assumes Full Development and Commercial Control of Galapagos’ Cystic Fibrosis Assets
NORTH CHICAGO, Ill., Oct. 24, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that it will assume full development and commercial responsibility for its collaboration with Galapagos (Euronext: GLPG) to discover and develop new therapies to treat cystic fibrosis (CF). AbbVie’s research program aims to develop a …
-
18 October
AbbVie and Morphic Therapeutic Announce Collaboration Targeting Fibrotic Diseases
NORTH CHICAGO, Ill. and WALTHAM, Mass., Oct. 18, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Morphic Therapeutic, a biotechnology company developing oral integrin therapies, announced today that the companies have entered into a research and development collaboration designed to advance a number of Morphic’s oral integrin therapeutics for fibrosis-related indications. …
-
17 October
FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia
NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …