Pharmaceutical Technology Editors

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.

Innovator companies are exploring new avenues to keep generic drugs at bay, says CPhI expert, but competition authorities and drug regulators will play a key role in preventing such abusive anti-competitive practices.

The CDMO is investing £6 million into a new facility at its United Kingdom site to expand its milling, micronization, and solid form capabilities.

The agency has published educational material for physicians promoting the benefits of biosimilars.

The biopharmaceutical company has received a $4.2-million grant from the Bill & Melinda Gates Foundation to invest in the development of new treatments for Enterotoxigenic Escherichia coli infections, a bacterial cause of diarrhea in the developing world.

The API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

The company is recalling several injectable products because of possible microbial contamination.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

The clinical-stage biopharmaceutical company has announced the opening of a new gene therapy manufacturing facility in Modiin, Israel, which is anticipated to be the production site of the company’s lead cancer drug candidate.

The biotechnology company has officially opened its new Michigan research and production center for the production of spider silk-based fibers, as well as for the company’s polymer research and development program.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

SCHOTT began production of glass ampoules, vials, and cartridges at a new facility at the SCHOTT Xinkang headquarters in Zhejiang, China.

The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.

The companies will embark on a joint antimicrobial research project, with the intent to discover antibiotic combinations that target resistance.

Girish Malhorta, CPhI expert and president of EPCOT International, discussed world revenues for pharmaceuticals and how companies may improve cost and availability of drugs in CPhI’s 2017 Annual Report.

Pharma companies are responsible for excipient quality, but they face challenges, including quality and a regulatory environment that discourages development of new, pharma-specific excipients.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

The two companies announced their collaboration for the production and development of cancer vaccines.