Pharmaceutical Technology Editors

Pfizer to Acquire FoldRx; Protalix Appoints COO; And More.

Roche (Basel) launched a groupwide operational-excellence initiative intended to modify the company's cost structures and accelerate its productivity improvements.

ICH to Hold Training Workshops for Quality Guidelines

FDA Provides Information On Advisory Committees, Announces Public Meetings, And More.

Genzyme (Cambridge, MA) confirmed that it had received sanofi-aventis's (Paris) proposal to acquire all of its outstanding shares for $69 each.

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

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Regulatory Roundup: PDUFA Fees Published, And More.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Commissioner Hamburg Says China is Improving Export Regulation

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2010 edition from Lechler and Thermo Fisher Scientific.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

This week, the US Food and Drug Administration published on its website a summary of good manufacturing practices for the holding and distribution of drug products.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

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

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

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.