inhibitor – Page 2 – media

U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer

Janssen Biotech, Inc. (Janssen) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
- Source: Janssen
- 489
- December 25, 2017
CRPC inhibitor New Approvals
AbbVie Scores Key Trial Win for RA Drug With One Fatal Event Reported

AbbVie’s investigational JAK1-inhibitor upadacitinib yielded positive top-line results in a Phase III trial as a monotherapy for rheumatoid arthritis patients. But the drug shows that it is still plagued by some safety concerns.
- Source: Biospace
- 577
- December 21, 2017
Clinical Trials inhibitor Phase rheumatoid arthritis
Alexion and Halozyme Enter License Agreement for ENHANZE Technology

Alexion Pharmaceuticals, Inc. (ALXN) and Halozyme Therapeutics, Inc. (HALO) announced a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE® drug-delivery technology in the development of subcutaneous formulations for their portfolio of products. The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.
- Source: news.alexionpharma
- 498
- December 12, 2017
ALXN1210 formulation inhibitor Market Views
FDA approves new treatment Hemlibra (emicizumab-kxwh) to prevent bleeding in certain patients with hemophilia A

The U.S. Food and Drug Administration(FDA) approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
- Source: pharmacist
- 744
- November 20, 2017
FDA Hemlibra hemophilia inhibitor New Approvals
FDA approves new drug to treat bleeding in hemophilia A patients

The U.S. Food and Drug Administration(FDA) today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
- Source: news-medical
- 632
- November 17, 2017
FDA Hemlibra inhibitor pediatric
GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma

In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
- Source: gsk
- 556
- November 3, 2017
inhibitor multiple myeloma New Approvals refractory relapsed
Merck sales slip, even as Keytruda gains ground

Keytruda (pembrolizumab) was the main bright spot for Merck as it weathered blows from the NotPetya cyber attack, new competition and pricing pressures in hepatitis C.
- Source: 4-traders
- 691
- October 31, 2017
hepatitis inhibitor keytruda Market Views Opdivo
‘Handful of changes’ make cancer

British scientists have worked out how many changes it takes to transform a healthy cell into a cancer.
- Source: bbc
- 804
- October 23, 2017
cancer herceptin inhibitor tumour
Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Pfizer Inc. today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated.
- Source: Pfizer
- 692
- October 17, 2017
Clinical Trials inhibitor Phase tyrosine kinase
Checkpoint Therapeutics Receives Orphan Drug Designation for CK-101 for the Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT)'s Orphan Drug Designation to CK-101 (also known as RX518), the Company’s third-generation epidermal growth-factor receptor (EGFR) inhibitor, for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 505
- September 12, 2017
FDA inhibitor NSCLC

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