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Lilly Discontinues Phase III Rheumatoid Arthritis Program

February 12, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Eli Lilly and Co. announced that it will discontinue its Phase III rheumatoid arthritis program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, because of lack of efficacy.

Drug Discovery Initiative Launched in Europe

February 11, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

An international consortium of pharmaceutical companies, academia, research organisations and other related entities have launched a new platform to help enhance drug discovery in Europe.

FDA Lists Guidance Documents Planned for 2013

February 5, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has released a list of more than 50 guidance documents planned for 2013.

GMP Compliance Becomes Prominent Enforcement Issue

February 2, 2013

Pharmaceutical Technology

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

Modernization of USP Standards

February 2, 2013

Pharmaceutical Technology

The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.

European Commission Investigates J&J and Novartis

February 1, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Pfizer Reports Fourth-Quarter and Full-Year 2012 Financial Results

February 1, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.

US Pharmacopeial Convention Announces Revised Official Dates for Elemental Impurities Chapters

January 31, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Endo Pharmaceuticals and GVK Biosciences Form Research Collaboration

January 30, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a contract research organisation (CRO) based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialisation of the product.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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