Home / Oncology (page 30)

Oncology

FDA Grants Orphan Drug Designation to MediciNova’s Investigational Glioblastoma Candidate

LA JOLLA, Calif., Oct. 04, 2018 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) as …

Read More »

Kite and HiFiBiO Collaborate to Develop Technology for Potential Discovery of Neoantigen-Reactive T Cell Receptors for the Treatment of Cancer

SANTA MONICA, Calif. & HONG KONG–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics, a biotechnology company focused on the discovery of therapeutic antibodies through single B cell screening and analysis, announced the companies have entered into a research collaboration and license agreement to develop technology supporting the discovery …

Read More »

FDA Grants Breakthrough Therapy Designation to Clovis Oncology’s Rubraca for BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca® (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy. Breakthrough Therapy designation is granted …

Read More »

GO Therapeutics Enters into a License Agreement with Roche for New Glycotargeting Bispecific Cancer Treatment

CAMBRIDGE, Mass.–(BUSINESS WIRE)–GO Therapeutics, Inc. (GO), a company applying new advances in glycoproteomics to develop antibody-based cancer therapeutics, today announced that it has entered into a license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche). Under the terms of the agreement, GO will grant Roche a worldwide, …

Read More »

Cellectar Announces Overall Survival Exceeding 19 Months in Phase 1b Trial with CLR 131 in Relapsed/Refractory Multiple Myeloma

MADISON, Wis., Oct. 02, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the …

Read More »

FDA Approves Amgen’s sNDA for Kyprolis in Patients with Relapsed or Refractory Multiple Myeloma

THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. The …

Read More »

Dragonfly Collaborates with Merck to Develop Novel Drug Candidates for Solid Tumors Using Dragonfly’s TriNKET Platform

WALTHAM, Mass., Oct. 1, 2018 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly”), today announced a strategic collaboration with Merck, known as MSD outside the United States and Canada, through a subsidiary, to discover, develop and commercialize innovative immunotherapies for patients with solid tumor cancers. The collaboration grants Merck the option to …

Read More »

Seattle Genetics and Takeda Announce Positive Phase 3 Results for Adcetris in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) announced today that the phase 3 ECHELON-2 clinical trial met its primary endpoint. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) of ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, …

Read More »

FDA Authorizes Adaptive’s clonoSEQ Assay to Detect MRD in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies® announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance …

Read More »

FDA Approves Libtayo as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint …

Read More »