Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

Gilead to Buy Kite Pharma for $11.9 Billion

August 29, 2017

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda to Partner for PD Treatment

August 29, 2017

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

Steam Sterilizers for Laboratory Applications

August 28, 2017

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

Genentech Gets Priority Review for Hemophilia A Biologic

August 24, 2017

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

CPI Joins Consortium for Automated Continuous Biologics Purification

August 24, 2017

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

August 21, 2017

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Pfizer Gets FDA Approval for New Leukemia Drug

August 18, 2017

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

Biocon Withdraws Breast Cancer Biosimilar Filings in Europe

August 18, 2017

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

Regeneron Halts Development of RSV Biologic

August 15, 2017

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

SGS Expands Bioanalytics Capacity

August 14, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.