BioPharm International Editors

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

Two of the medicines recommended for approval are orphan drugs.

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

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.

The company has introduced two new GMP vessel streams at its API manufacturing facility in Northumberland, UK that allows it to now offer fully integrated drug substance and drug product manufacturing.

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

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

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

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

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.

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

The voluntary recall is due to blister packages containing the incorrect product.

Supply Chain Wizard has developed a set of integrated digital solutions to improve supply chain functions.

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

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.

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

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

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

The contract research organization (CRO) has acquired Xenometrics, a non-clinical CRO specializing in preclinical assessment of new drug candidates.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The biotechnology company has entered a contract with the United States Army to develop custom recombinant spider silk for protective textile applications.

Wyatt Technology has added the DynaPro Plate Reader III to its macromolecular and nanoparticle characterization product offerings.

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.

Inovio has reported results from a study with non-human primates that showed 100% effectiveness with a DNA vaccine the company is developing with the US Army.