Drug Development

Articles

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

WuXi and Pall Establish Continuous MAb Manufacture

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

Dynavax Wins FDA Approval for Hep B Vaccine

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

Recipharm Reveals Plans to Discontinue Operations in Two Swedish Facilities

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

New Study Challenges Current Theories on Skin Delivery of Macromolecules

The company has officially opened a local brand office in South Korean to support its existing business in the region.

Vetter Expands in Asia-Pacific

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

Biosimilars Raise Analytical and Policy Challenges

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.  

Human Vaccines Project Creates Research Program to Develop Universal Influenza Vaccines

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.

Celonic Acquires Glycotope’s Biomanufacturing Facility

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Formulation and Drug Delivery