APIs and Excipients

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

December 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Hazardous Chemistry: Choosing Batch or Flow

December 02, 2017

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

GE Healthcare Completes Acquisition of Bioprocessing Start-Up

November 28, 2017

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

Avista Doubles API Manufacturing Capacity at Colorado Facility

November 20, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.

FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug

November 20, 2017

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion

November 16, 2017

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Bayer in $1.5-Billion Deal with Loxo Oncology for Anti-Cancer Drugs

November 16, 2017

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases

November 15, 2017

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

Nitto Avecia Completes Large-Scale Synthesis of Oligonucleotide

November 13, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

WuXi and Pall Establish Continuous MAb Manufacture

November 13, 2017

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.