News

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.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

Express Scripts announced its plan to offer a $1 alternative to Daraprim, a generic drug used for the treatment of toxoplasmosis.

Intellectual challenge, job security, and opportunity for advancement contribute to employee happiness, but the ultimate prize may be a satisfactory salary for bio/pharma employees in Europe.

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.

The Committee on Energy and Commerce met to assess influenza vaccine effectiveness, and changes for the 2015-2016 season.

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.

As 3-D screening and lab automation improve lead optimization, open collaborative models are breaking down long-established walls. Will the industry redefine the way it handles R&D?

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

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.

The portal is an interactive tool that pulls together the innovation landscape, company base, and manufacturing sites for the entire medicines sector in the UK.

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.

Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.

With the acquisition of Medipac’s tube filling assets for effervescent tablets, Romaco can now offer the complete line configurations for effervescent tablets.

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

The Nexera UC Unified Chromatography System from Shimadzu Scientific Instruments was recognized with an R&D100 award.