Florida is making its case for pharmaceutical and biotechnology research and development.

An authoritative book helps drug developers face one of their toughest problems.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

Brief pharmaceutical news items for May 2008.

WFI system deficiencies and damp tax records cause problems for two plants

According to the latest figures from IMS Health, Inc., Japan's pharmaceutical market is expected to grow 1–2% this year compared to global industry growth expectations of 5–6%.

One of the headlines before going to print was 'Pfizer earnings suffer as patent expiries cause damage'. This US pharma giant has reported a net income decline of 18% for the first quarter, despite the positive impact of the favourable currency rates.

Congress is taking on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Act of 2008.

US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, "Restoring FDA's Ability to Keep America's Families Safe."

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country's drug supply.

Ell Lilly plans to streamline a portion of its manufacturing operations in Indianapolis.

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA Form 3674 when submitting documentation to the Agency in order to comply with FDAAA, Title VIII.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

The US Food and Drug Administration appointed Frank M. Torti, M.D., M.P.H, as principal deputy commissioner and chief scientist. Torti's appointment with FDA will begin in May.

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

MannKind suspended discussions with potential partners for the commercialization of its "Technosphere Insulin" product.

This issue of Equipment & Processing Report features products from Leistritz and Millrock Technology

Dave Drew, group pharmaceutical director of Matcon (Moreton-in-Marsh, UK), says that lean production is essential for drugmakers to survive in the current environment.

Takeda Pharmaceutical agreed to acquire Millennium Pharmaceuticals for $8.8 billion in cash or $25 per share.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, Jubilant Organosys to acquire DRAXIS Health, PPD's Paul Covington to retire, more...

In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).

Senator Chuck Grassley (R-IA) sent a letter to Amgen (Thousand Oaks, CA) last week asking the company to account for the high rebates it has given to certain physician groups who bought Aranesp.

Combining atomic force microscopy and infrared spectroscopy, scientists at the University of Illinois have demonstrated a method for simultaneous structural and chemical characterization of samples at the femtogram (10-15g) level.