
European Medicines Agency Issues Drug Review Update; And More

European Medicines Agency Issues Drug Review Update; And More

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

ICH Draft Residual Solvents Guideline Published; And More.

Merck KGaA (Darmstadt, Germany), a global pharmaceutical and chemical company, completed its acquisition of Millipore (Billerica, MA), a life-science company, last Thursday for an aggregate purchase price of roughly EUR 5.2 billion ($6.7 billion).

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2010 edition from Gems Sensors and Controls and Telstar.

With the right technology tools, the sponsor organization and the contract manufacturer can have self-service, on-demand, and scheduled access to all manufacturing, quality, and process-development data.

The US Food and Drug Administration announced last week that it will be "conducting a series of inspections in an effort to evaluate industry's compliance and understanding of [21 CFR] Part 11."

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

Ethics Group Calls on FTC to Investigate Drug Pricing

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

A roundup of developments on corporate social responsibility from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

The US Food and Drug Administration's website now features a free online 90-minute training program on the "Past, Present, and Future of FDA Human Drug Regulation."

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

The European Medicines Agency and the European Monitoring Center for Drugs and Drug Addiction to Cooperate.

GSK Acquires Laboratorios Phoenix; Catalent Makes Executive Appointments; And More.

A roundup of developments on corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other organizations.

Thermo Fisher to Acquire Fermentas; Pfizer Names Head of R&D; And More.

Regulatory Roundup: USP and Russia's Roszdravnadzor Sign MOU

The US Food and Drug Administration began a partnership with the website Drugs.com to expand access to the agency's consumer-health information.

Despite its potential, why is personalised medicine still not widely used in healthcare?

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

FDA and NIH Launch New Safety Reporting Website; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.