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The latest business, scientific & regulatory news from the pharmaceutical and biotechnology industries. Trends & international news from global correspondents and breakthroughs in research in Coming Down the Pike.

Lonza Restructures, Plans Cost Reductions

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

Lonza (Basel, Switzerland), the large contract manufacturer of small-molecule and biologic-based active pharmaceutical ingredients (APIs), announced last week a series of cost-cutting measures for the next 12 to 18 months.

USP Revises Excipient Standards to Limit Contamination

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

Europe May See 10 New Orphan Products a Year

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Organization for Rare Diseases (EURORDIS) predicts that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year.

SOCMA Hails FDA Action on Citizen Petition Regarding Inspections

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.

Novartis To Invest $1 Billion in China R&D Institute

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

Novartis (Basel, Switzerland) plans to invest $1 billion over the next five years to increase research and development activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

ICH Adopts Pharmacopeial Text Annexes and Prepares for Global Quality Implementation

November 5, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

Cargill updates industry on portfolio innovations

October 30, 2009

Pharmaceutical Technology Europe

Cargill has recently announced a number of innovations connected to its range of polyol excipients.

Pfizer accused of corporate arrogance

October 30, 2009

Pharmaceutical Technology Europe

A complaint submitted to the Federal Trade Commission has referred to Pfizer's acquisition of Wyeth as "potentially monopolistic" and has urged the Commission to see that "the proposed merger is not in the public interest and is in conflict with a wide range of President Obama's objectives".

Optimizing drug delivery to the lungs

October 30, 2009

Pharmaceutical Technology Europe

An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers.

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