Specialty Pharma Journal Specialty, Precision & Technology
The University of Texas MD Anderson Cancer Center and Pfizer Inc. today announced that they have entered into a clinical collaboration to study novel combinations of three Pfizer investigational immuno-oncology therapies and other Pfizer agents in the treatment of various solid tumors and hematologic malignancies. “This alliance aims to define patients …
Tag Archives: solid tumors
September, 2017
July, 2017
-
24 July
FDA Expands Approval of Yervoy to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: …
-
6 July
Celgene Enters Cancer Immunotherapy Deal with BeiGene for its Investigational PD-1 Inhibitor
SUMMIT, N.J. & BEIJING–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) and BeiGene, Ltd. (NASDAQ:BGNE) entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally …
-
5 July
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the use …
June, 2017
-
19 June
FDA Accepts Amgen’s sBLA to Expand Approval of Xgeva to Include Multiple Myeloma Patients
THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients …
May, 2017
-
23 May
FDA Grants Accelerated Approval to Merck’s Keytruda for Solid Tumors with Specific Biomarkers
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 approved a new indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, …
-
15 May
FDA Grants Breakthrough Therapy Designation to Ignyta’s Cancer Drug Entrectinib
SAN DIEGO–(BUSINESS WIRE)–Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib “for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric …
April, 2017
-
10 April
FDA Accepts Syros’ IND to Advances its CDK7 Inhibitor SY-1365 into Phase 1 Clinical Trial in Advanced Solid Tumors
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application to advance SY-1365, its first-in-class selective cyclin-dependent kinase 7 …
March, 2017
-
24 March
BioLineRx Acquires Cancer Immunotherapeutics Company Agalimmune
Tel Aviv, Israel – March 23, 2017 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has acquired Agalimmune Ltd., a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition consideration consisted of a $6 million upfront payment, of which …
-
17 March
Scripps Florida Scientists Develop New Drug Delivery Method for Cancer Therapy
JUPITER, FL – March 16, 2017 – Scientists from the Florida campus of The Scripps Research Institute (TSRI) have developed a new drug delivery method that produces strong results in treating cancers in animal models, including some hard-to-treat solid and liquid tumors. The study, led by TSRI Associate Professor Christoph …