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FDA Grants Breakthrough Status to Novartis Investigational Drug

June 25, 2013

Serelaxin, to treat acute heart failure, is the second Novartis drug to get new designation from FDA.

FDA Issues Draft Guidance on Contract Manufacturing

May 28, 2013

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

USP Defers Implementation of Elemental Impurities Provisions

May 28, 2013

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

FDA Issues Warning Letter to Boehringer Ingelheim for cGMP Violations

May 28, 2013

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

Pfizer Halts Phase III Trial of Cancer Drug in NHL Due to Futility

May 22, 2013

Pfizer has discontinued a Phase III study of its investigational cancer drug, inotuzumab ozogamicin, in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) after it failed to show benefit in overall survival.

Pfizer Opens Online Pharmacy to Fight Counterfeit Medicine

May 6, 2013

Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine.

The New Normal In Biotech Financing

May 3, 2013

PTSM: Pharmaceutical Technology Sourcing and Management

Financing to biotech companies in North American and Europe declined in 2012 as debt funding decreased and the IPO market remained weak.

Big Pharma's Manufacturing Investments in Biologics

May 1, 2013

Pharmaceutical Technology

Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing.

Pharmaceutical Technology and D&B Launch Business Marketplace

April 26, 2013

Pharmaceutical Technology has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace.

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