Industry News - BioPharm International

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Industry News
The latest news about industry suppliers, business activities, people.

Meet This Year's CPhI Pharma Awards Winners

October 7, 2014

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

FDA Releases Q&A on DQSA

October 7, 2014

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

FDA Releases Guidance on Critical Path Innovation Meetings

October 7, 2014

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

FDA Releases Guidance on OTC Pediatric Drug Products

October 7, 2014

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

FDA Releases First-Ever Purple Book for Biosimilar Characterization

September 26, 2014

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

USP Supports WHO Biologics Naming Proposal

September 25, 2014

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

PCI Acquires Biotec

September 19, 2014

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

BioTime Subsidiary Partners with Cancer Research UK in Clinical Trial of Lung Cancer Treatment

September 12, 2014

Asterias Biotherapeutics, Cancer Research UK, and Cancer Research Technology partner for clinical trial of immunotherapy vaccine for the treatment of lung cancer.

European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing in EU

September 12, 2014

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

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