Pharmaceutical Technology Editors

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.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

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

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

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

The pharmaceutical packaging and drug delivery conference has announced its event program taking place on Feb. 7–8, 2018 at Paris Expo Porte de Versailles in France.

FDA announced a public workshop to explore strategies for addressing the crisis of opioid addiction through innovations in packaging, storage, and disposal.

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.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

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 biotechnology company’s drug for treating hives in adults has been granted an expanded indication by the European Commission to treat children and adolescents.

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.

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

The company’s board of directors has appointed Aron Knickerbocker as the new president and CEO to succeed Lewis Williams, MD, PhD, effective Jan. 1, 2018.

This year’s awards attracted more than 200 entries, which included innovations in products and service offerings from across the pharmaceutical supply chain and honored companies and individuals driving the industry forward.

Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.

Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines.

The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.