Industry News

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

The Purple Book will list biologic and biosimilar products and will serve as a guide for interchangeability.

NIH continues funding for tissue chips to be used in the development of therapeutics.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Regulations, product protection, and cost management are top concerns of supply chain decision makers.

PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

European Commission granted the first biosimilar insulin to receive regulatory approval in Europe.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

ProBioGen, a biopharmaceutical drug manufacturer in Berlin, spends ?20 million to double its workforce.

PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.

Three-year agreement will support research on treatments for major brain disorders in Neuroscience Catalyst project.

Researchers show TIM-1 proteins and lipids play role in blocking HIV-1 cells and Ebola from replicating.

ISPE released an advance look at the Introductory Summary of its Drug Shortages Prevention Plan.

PSC Investments announces the acquisition of a high potency, sterile fill/finish pharmaceutical manufacturing facility.

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

Former healthcare association executive selected to lead International Society for Pharmaceutical Engineering.

CPhI 2014 panel additions to provide global insights from the contract services sector.

ASTM International develops Committee E62, a new technical committee focused on industrial biotechnology.

OCE and OBI partner with CQDM on $3 million inter-provincial drug discovery innovation programs.

BioOutsource will expand its US presence, opening a new laboratory facility in Massachusetts to support the company's biosimilar and biosafety service offerings.