Most Viewed Articles - Pharmaceutical Technology

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Decades of Change for the Top Pharmaceutical Companies

July 11, 2012

PTSM: Pharmaceutical Technology Sourcing and Management

Tracking change from spinoffs of chemical companies to life-sciences powerhouses.

Congress Passes Generic Drug Act

July 10, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities

July 9, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

July 3, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

GSK Agrees to $3 Billion Settlement with Justice Department

July 3, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.

Bristol-Myers Squibb Agrees to Acquire Amylin for $5.3 Billion

July 2, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin's net debt and a contractual payment obligation to Eli Lilly based on Amylin's recently terminated agreement with Eli Lilly over the diabetes drug exenatide.

Atypical Visible Particles

July 2, 2012

Pharmaceutical Technology

An industry roundtable on how users and makers can best assess and manage black specks.

High-Potency Manufacturing Remains Strong

July 2, 2012

Pharmaceutical Technology

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Commentary: Healthcare Reform is Ruled Constitutional

June 29, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

In a 5–4 vote, the Supreme Court has ruled in favor of the Constitutionality of the Affordable Care Act.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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