Pharmaceutical Technology Editors

The company is recalling product because of microbial contamination.

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the United States.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

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

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

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.

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

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.

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

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

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.

The company has completed a small-scale capacity expansion at its site in Charles City, IA.

The company has appointed Albert Bourla, PhD, as its new COO.

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

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

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

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.