Pharmaceutical Technology Editors

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

Biocorp’s Easylog smart sensor for insulin delivery devices enhances compliance.

Innovations awarded at Pharmapack Europe include improvements for patient compliance and protection from errors, tampering, or misuse.

Ashland Chemical’s Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

The agency prepares a plan to implement new packaging safety features.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

AMETEK announced the acquisition of Brookfield Engineering Laboratories, a Massachusetts based manufacturer of viscometers and rheometers.

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

LabConnect built a biorepository facility in Tennessee.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

Catalent Pharma Solutions’ technical project manager, Elanor Pinto-Cocozza, PhD, will present at InformEx 2016.

Systag, a Swiss fine chemicals and process automation company, appeared at InformEx 2016

InformEx, a conference for the fine and specialty chemicals industry, kicked off on Feb. 2, 2016 in New Orleans.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

The chemical distribution industry has formed an international chemical trade association to address global issues.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

Amgen announces FDA will review the company’s BLA for ABP 501.