News

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The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and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.

Schering-Plough announced a major new productivity transformation program with a goal of achieving $1.5 billion in annual savings.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.

At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.

One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.

US pharmaceutical and biotechnology research companies invested $58.8 billion in research and development in 2007, according to analyses by the Pharmaceutical Research and Manufacturers of America and Burrill & Company.

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.

The former formulation-development business of MDS Pharma Services seeks to build its niche in early-phase drug development.

A reference book omits important information and ignores advanced testing procedures.

Financial experts share their insights for the performance for innovator drug companies and generic-drug players.

Excipient producers and industry observers share their perspectives on innovation for excipients.

Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.