Industry News

News, world briefs, facility roundup, events and other items for January 2008.

Although overall pharmaceutical industry investment in R&D in Spain is growing at a slower annual level since 2004, investment in clinical trials remains strong.

Congress Focuses on FDA Inspections of Foreign Drug Facilities; Medical Students Oppose Big Pharma's Influence on Campus; FDA Revises Postmarketing Reporting Requirements

The US Food and Drug Administration launched a new program on Oct. 4 to increase the number and variety of generic drugs available to the public, beginning in fiscal year 2008. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the agency "modernize and streamline the generic drug approval process," according to FDA.

The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in September in a 220-175 vote. Although the bill aims to fix current flaws in the US patent system and to bring it in line with those of other countries' systems, the biopharmaceutical industry is largely unhappy with the news, arguing that it will reduce patent protection.

US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines

Washington, DC (June 25)-More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey (HINJ). Modest job growth in this field is expected for the next four years, states the report.

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's (New York, NY, www.ey.com) annual analysis of the biotechnology industry. Its report, "Beyond Borders 2007," was issued at the Biotechnology Industry Organization's (BIO, www.bio.org) annual conference and exhibition, which was held in Boston May 6–9.

Sanofi to Close Irish Plant, FDA Inspections and Warning Letters Continue to Decline, FDA Submits Final Proposals for PDUFA IV, and more.

BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics

The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.

The injunction blocks rules that required secondary wholesalers to supply pedigrees tracing the chain of custody to the maker.

Defects in Herceptin vials stem from a fault in the packaging process.

Proof of concept is a new development paradigm.

FDA conducted 163 inspections of foreign API manufacturers in 2005.

GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.

FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.

The worldwide market for biopharmaceuticals was estimated to be $50 billion in 2005. North America accounts for 60% in terms of revenue and R&D. Europe accounts for 20% and Japan 10%. It is also estimated that 400–500 biotech drugs are under clinical development for various disease conditions. Biopharmaceuticals are being developed to fight cancer, viral infections, diabetes, hepatitis and multiple sclerosis. The distinct families of biopharmaceuticals include

Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.

Pharmaceutical Science & Technology News

Although it has recently been surpassed by Mexico in terms of value, the Brazilian pharmaceutical market remains of key importance to companies establishing themselves in Latin America. The Brazilian government has focused heavily on improving the healthcare system and this should lead to long-term benefits for its citizens. The Ministry of Health has also attempted to decentralize the management of the healthcare system to more regional and local levels. This has been necessary to account for the different healthcare priorities in different parts of the country.

Pharmaceutical Science & Technology News

This column provides a summary of the key trends that are occurring within pharma–biotech alliances, as well as looking at biotech–biotech. It will explore the changing balance of power in pharma and biotech deals, providing examples and insights into which areas alliances are becoming increasingly popular.

Gottlieb challenges industry. First GenerationNext Awards. Implementing PAT. Optimizing site risk. RFID in the supply chain. Biodegradable polyketals. Global drug-market growth moderates.

The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

The right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security.

Flu vaccines. Dow veterinary vaccine made in plants. $1.95 billion FDA budget focuses on high-profile programs. Non-injectable insulins win approval. FDA releases guides to dissolution testing, quality overall summary, and new drug-label formats.

Pharma companies are forming alliances with less established biotech companies, which significantly drive the technological innovation and the overall market growth.