Pharmaceutical Technology Editors

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

This marks Vetter’s fourth internationally recognized award for its syringe closure system, Vetter-Ject.

The collaboration will allow the companies to develop and manufacture novel inhaled therapeutics.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

Growth in finished dosage formulations triggers a new CPhI Worldwide event.

Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.

Sartorius announced the release of the company’s new Tacta pipettes.

Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

MPI Research plans to renovate more than 55,000 square feet of facility space as part of the company’s plan to invest in upgrades and department expansion.

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.