Industry News

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

FDA granted priority review status for XALKORI for the treatment of patients with NSCLC with ROS1-positive tumors.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

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

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.

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

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

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

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.

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.

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

FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.

FDA has approved ixazomib, the first approved oral proteasome inhibitor.

UPS’ 2015 “Pain in the Chain” survey suggests that pharma companies are getting better at product protection, cold chain and regulatory compliance, but need to improve cost control and planning for unexpected events. Lack of transparency and “too many handoffs” remain major challenges.

Charles River Laboratories announces the acquisition of Oncotest GmbH.

The agency issues guidance on the labeling of over-the-counter products that contain acetaminophen.

The new executive director of the European Medicines Agency begins appointment.

An ABPI report found a lack of quality candidates for high-skilled roles in areas such as bioinformatics, translational medicine, clinical pharmacology, and pathology.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

Lawsuit alleges birth control packaging error led to 113 unwanted pregnancies.

The European agency presents guidelines for conducting post-authorization efficacy studies.

FDA noted multiple manufacturing, testing, and labeling violations at American Family Pharmacy’s Indianapolis facility.

Pharma Integrates 2015 will be held on Tuesday 17th and Wednesday 18th November 2015 at the Grange City Hotel, London.

The IQ Consortium is an organization that brings together pharma and biotech companies and facilitates partnerships between members.

Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.