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Latest Biotechnology, Pharmaceutical and Healthcare News from Speciality Pharma Journal

13:22 EDT 19th July 2018 | BioPortfolio

Here are the most relevant search results for "Speciality Pharma Journal" found in our extensive news archives from over 250 global news sources.

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Showing News Articles 1–25 of 421 from Speciality Pharma Journal

Wednesday 18th July 2018

FDA Approves Two New Indications for Novartis’ Breast Cancer Drug Through Novel Pilot Programs

Basel, July 18, 2018 – Novartis today announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-...

CTI BioPharma Announces Pacritinib Program Update Following Type B Meeting with the FDA

SEATTLE, July 18, 2018 /PRNewswire/ — CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it recently conducted a Type B meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate pacritinib. The purpose of the meeting was to discuss the regulatory pathway for pacritinib. Based on FDA feedback, the Company plans to conduct a randomized Phase 3 study in...

Pfizer and Lilly Announce Positive Top-Line Results from Late-Stage Trial of Tanezumab for Treatment of Osteoarthritis Pain

NEW YORK, & INDIANAPOLIS–(BUSINESS WIRE)–Pfizer Inc.(NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two dose...

FDA Grants Priority Review to Immunomedics’ Sacituzumab Govitecan for the Treatment of Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., July 18, 2018 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review for sacitu...

Sanofi and REVOLUTION Medicines Partner to Develop Targeted Therapies for Multiple Cancers

CAMBRIDGE, Mass. & REDWOOD CITY, Calif.–(BUSINESS WIRE)–Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations. This collaboration builds on precision onco...

FDA Grants Breakthrough Therapy Designation to Genentech’s Tecentriq in Combination with Avastin as First-Line Therapy for Advanced HCC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for TECENTRIQ®(atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular...

FDA Approves Janssen’s Symtuza, the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV

TITUSVILLE, N.J., July 17, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. SYMTUZA...

Boehringer Ingelheim Exercises an Option to License Novel TCR Mimic Antibodies from Eureka Therapeutics

EMERYVILLE, Calif.–(BUSINESS WIRE)–Eureka Therapeutics Inc. announced today that Boehringer Ingelheim has elected to exercise an option for the exclusive license of novel human TCR-mimicking (TCRm) antibodies against an undisclosed target to be used for the potential development and commercialization of therapies for cancer patients. The licensed TCRm antibodies were developed under a ...

Tuesday 17th July 2018

FDA Grants Fast Track Designation to Tonix Pharmaceuticals’ Investigational Treatment for Agitation in Alzheimer’s Disease

NEW YORK, July 16, 2018 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer’s disease. The same drug, TNX-102 SL, or Tonmya®*, for the treatment of …

FDA Approves Xtandi for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer

TOKYO & NEW YORK–(BUSINESS WIRE)–Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial...

Friday 13th July 2018

FDA Lifts Clinical Hold on Advaxis’ Phase 1/2 Combination Study of Axalimogene Filolisbac with Durvalumab

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s Investigational New Drug (IND) application for its Phase 1/2 study of axalimogene filolisba...

Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for ...

Dermavant Enters $330 Million Deal for Rights to GSK’s Investigational Psoriasis Drug

GSK today announced that Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programmes for a total consideration of £250 million, including an initial payment of £150 million and a …

Thursday 12th July 2018

Zogenix’s ZX008 Demonstrates Positive Results in Late-Stage Dravet Syndrome Study

EMERYVILLE, Calif., July 12, 2018 (GLOBE NEWSWIRE) —  Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its second confirmatory Phase 3 study (Study 1504) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of child...

FDA Grants Orphan Drug Designation to Acceleron’s Facioscapulohumeral Muscular Dystrophy Drug

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation for ACE-083, the Company’s locally acting “Myostatin+” muscle agent, for...

Genmab Partners with Immatics for Development of Next Generation Bispecific Cancer Immunotherapies

Copenhagen, Denmark; July 12, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that it has entered into a research collaboration and exclusive license agreement with privately owned Immatics Biotechnologies GmbH (Immatics), to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. The deal strengthens Genmab’s position in immuno-oncol...

AbbVie Submits sNDA to FDA for Venetoclax in Newly Diagnosed AML Patients Ineligible for Intensive Chemotherapy

NORTH CHICAGO, Ill., July 12, 2018 /PRNewswire/ — 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 diagnose...

Wednesday 11th July 2018

FDA Commissioner Scott Gottlieb Statement on Agency’s Efforts to Advance Development of Gene Therapies

Once just a theory, gene therapies are now a therapeutic reality for some patients. These platforms may have the potential to treat and cure some of our most intractable and vexing diseases. The policy framework we construct for how these products should be developed, reviewed by regulators, and reimbursed, will help set the stage for …

Takeda’s Ninlaro Met Primary Endpoint in Phase 3 Trial as Maintenance Therapy in Patients with Multiple Myeloma Post-Transplant

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO®(ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial eval...

Otsuka to Expand its Pipeline of Antibody-Based Therapies through its $430 Million Acquisition of Visterra

TOKYO & WALTHAM, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Visterra, Inc. (Visterra) announce that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Visterra for approximately USD 430 million in an all-cash transaction. The Otsuka and Visterra boards of directors have approved the transaction. Subject to customary cl...

Bristol-Myers Squibb’s Opdivo-Yervoy Combo Receives FDA Approval for Certain Patients with Metastatic Colorectal Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch...

Imbruvica Fails to Meet Primary Endpoint in Phase 3 Trial in Newly Diagnosed Non-Germinal Center B Cell Subtype of DLBCL

RARITAN, N.J., July 11, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today topline results from the Phase 3 PHOENIX trial evaluating the investigational use of IMBRUVICA® (ibrutinib) in the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin …...

FDA Grants Priority Review to Merck’s sBLA for Keytruda for Treatment of Advanced Hepatocellular Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced...

Tuesday 10th July 2018

Celgene’s Tecentriq Plus Abraxane Significantly Reduced the Risk of Disease Worsening or Death in Phase 3 TNBC Trial

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast ca...

Avella’s Use of AdhereTech Improves Adherence of Multiple Specialty Medications and Diseases

PHOENIX, July 10, 2018 /PRNewswire/ — Avella Specialty Pharmacy and AdhereTech are proud to share the results that their successful partnership continues to have for patients. Avella currently uses the AdhereTech program for five specialty medications, in programs with four different pharmaceutical manufacturers. Averaged across all patients and programs from 2015 through today, AdhereTech h...


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