Top News

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

Jul 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Pfizer Announces Restructuring

Jul 11, 2018

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Takeda Receives US Clearance for $62-Billion Acquisition of Shire

Jul 11, 2018

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

BioPharm eBooks

Single-Use Systems 2018 eBook
A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs. 

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Biopharma News

Otsuka to Acquire Visterra for $430 Million

Jul 16, 2018

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Pfizer Announces Restructuring

Jul 11, 2018

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Takeda Receives US Clearance for $62-Billion Acquisition of Shire

Jul 11, 2018

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Industry News

Drugs Containing Valsartan Recalled

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Generics Drive Finished Drug Market Growth in Korea

CPhI Korea to feature zone for finished dosage formulation drug products.

Supplier News

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Catalent Implements Optofluidic Platform for Cell-Line Development

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

Teva to Relocate US Headquarters to New Jersey

Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.

Upstream Processing

Optimizing Late-Stage and Commercial Cell-Culture Processes

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Comparing the Supply Lifecycle of Bioreactors

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Downstream Processing

The Challenge of Disruptive Technologies in Bioprocessing

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Purolite Launches New Protein A Resin

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Standards/Regulations

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

Sponsored Videos

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QbD and PAT in Biopharmaceutical Development
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Cell and Gene Therapies

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.

Analytics

Advances in Analytics for Bioprocessing

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Transcriptomics and the Production of Recombinant Therapeutics

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Formulation

Ionic Pill Could Replace Daily Injections for Diabetics

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Single-Use Boosts Fill/Finish in Commercial Biomanufacturing

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Biosimilars and Biobetters Strategies and Challenges

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-Use Systems

Entegris Acquires Flex Concepts

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

Single-Use Boosts Fill/Finish in Commercial Biomanufacturing

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Assurance of Supply

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

mAb Development

Optimizing Late-Stage and Commercial Cell-Culture Processes

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The Challenge of Disruptive Technologies in Bioprocessing

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Purolite Launches New Protein A Resin

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Vaccine Development

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Research Shows Promise for Syphilis Vaccine

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

New Research Hub Tackles Access to Vaccines

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

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