Pharmaceutical Technology Editors

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer’s OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.

Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Scientists at Rice University have developed a method to control the infectivity of viruses and gene delivery to the nuclei of target cells.

Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

The plant will manufacture Clariant’s moisture-control products to support the growing pharmaceutical packaging market in India.Clariant announced on Dec. 1, 2015 that it is investing CHF 10 million in a new packaging manufacturing plant in Cuddalore, India. The plant will manufacture Clariant’s moisture-control products to support the growing pharmaceutical packaging market in India.

Amgen announced the submission of a BLA with the FDA for ABP 501.

Vetter receives AEO-F certificate from the European Union for global movement of goods.

Xcelodose provides automated processing of API directly into capsules at low doses. The expansion of Xcelodose reinforces Juniper’s early stage capsule filling capability.CDMO Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, announced that it has expanded its Xcelodose powder micro-dosing system. This move reinforces the company’s early stage capsule filling capability.

CPhI and P-MEC India 2015 features exhibits and educational sessions for the Indian pharma industry.

KnowItAll spectroscopy software from Bio-Rad Laboratories corrects differences in spectra data.

The ReactoMate Datum controlled lab reactor system accommodates a range of vessel sizes.

Paras Biopharmaceuticals and Novozymes will collaborate on the creation of an improved osteoporosis treatment.

Charles River offers the Endosafe nexgen-PTS endotoxin testing system.

Agilent Technologies and Thermo Fisher Scientific exchange instrument control drivers and software support.

BMG LABTECH announces the release of a new reference multi-mode HTS reader at SLAS in January 2016.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

Copley Scientific’s new Vertical Diffusion Cell Test System Model HDT 1000 comprises a compact unit with 10 test stations that enables the precise control of test conditions.

The Safe Chain Track and Trace System automates traceability for supply chain security.

CSafe partners with Lufthansa Cargo in dedicating a fleet of RKN containers to Cool/td-Active service offering.

The goal is to have all of Novo Nordisk’s production plants operating on renewable electricity with zero CO2 emissions by 2020.