BioSpace News Archive

bioLIVE report forecast bioconjugation expertise and increased productivity in bio over next 5-years

Ahead of the inaugural edition of bioLIVE – the bioprocessing and manufacturing event opening October (9-11) in Madrid – CPhI Worldwide announces the bio findings of its annual report, which foresees much greater efficiency in biomanufacturing and an increased exchange of ideas across small and large molecule industries.

September 28, 2018
·
5 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
·
19 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
·
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
·
4 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
·
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
·
8 min read
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
·
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
·
9 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
·
3 min read
Drug Development

DEA Reclassifies GW Pharmaceuticals’ Epidiolex as a Schedule V Drug

The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.

September 28, 2018
·
3 min read
·
Alex Keown