BioSpace News Archive

FDA

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs

September 28, 2018
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4 min read
Policy

Advisory - EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Patients need to check their device to confirm that it can be removed from the carrier tube with ease

September 28, 2018
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3 min read
Business

Rensselaer Polytechnic Institute, United Health Foundation Launch $1.1 Million Partnership to Train Next Generation of Health Data Experts

Training will take place through the “Rensselaer Health INCITE Pipeline”

September 28, 2018
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3 min read
FDA

FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation

Xolair, the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications, is now also approved in a prefilled syringe (PFS) formulation

September 28, 2018
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8 min read
FDA

FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma

Libtayo is the third anti-PD-1 approved in the U.S.

September 28, 2018
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19 min read
FDA

FDA approves first treatment for advanced form of the second most common skin cancer

New drug targets PD-1 pathway

September 28, 2018
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4 min read
FDA

FDA Grants De Novo Designation for Adaptive Biotechnologies’ clonoSEQ Assay to Detect and Monitor Minimal Residual Disease (MRD) in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

clonoSEQ is a first-in-class NGS assay and the first and only FDA-cleared MRD assay for any lymphoid cancer

September 28, 2018
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9 min read
Deals

Takeda Establishes Record Date for the Extraordinary General Meeting of Shareholders

Company Announces Record Date and Highlights Significant Progress To-Date

September 28, 2018
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4 min read
Genetown

KSQ Therapeutics Secures $80 Million Financing and Advances Broad Pipeline of Cancer Therapies Including Its First Adoptive T-Cell Therapy Program for PD-1 Resistant Solid Tumors

Company’s Pipeline Spans Three Oncology Drug Categories: Adoptive T-Cell Therapies, Immuno-Oncology Monotherapies and Targeted Therapies

September 28, 2018
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4 min read
QIAGEN Applauds Bold UN Plan for Tuberculosis Prevention and Care

Global leaders commit $13 billion a year by 2022, including actions to detect and treat latent TB infection

September 28, 2018
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2 min read