News

Cardinal Health began construction on a $50 million expansion of its headquarters in Dublin, Ohio, on Oct. 3, 2007.

A recent report conducted by The Department of Health and Human Services, Office of the Inspector General is stirring some concern over how the US Food and Drug Administration conducts inspections of clinical trials.

Ranbaxy received full market approval from the US Food and Drug Admnistration for its anti-infective agent ?Clarithromycin? oral suspension.

Company and People Notes: Thermo Fisher Scientific buys Priority Solutions International, Wyeth elects new president and CEO, more.

President Bush signed the FDA Amendment Act into law, thereby reauthorizing the Prescription Drug User Fee Act (PDUFA).

A roundup of news from exhibitors at CPhI Worldwide.

Lancaster Laboratories (Lancaster, PA) acquired Microchem Laboratories (Waterford, Ireland). Microchem was established in 1986 and is one of Ireland's testing and research laboratories. Microchem offers microbiological, chemical, and environmental analyses to the pharmaceutical, medical-device, and chemical industries in Europe and Asia.

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.

Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.

The European Medicines Agency?s Committee for Medicinal Products for Human Use recommended the lifting of the suspension of the marketing authorization for ?Viracept? (nelfinavir mesylate) from Roche and the re-introduction of the drug in the European Union.

Reflecting a strategic interest to strengthen its position in biologics, Bristol-Myers Squibb agreed to acquire the biopharmaceutical company Adnexus Therapeutics for $430 million.

Rep. John D. Dingell (D-MI), chairman of the Committee on Energy and Commerce, along with Reps. Frank Pallone (D-MI), chairman of the Subcommittee on Health, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, introduced legislation that would create a user fee on imported drug and food shipments.

The US Food and Drug Administration has denied shipments of active pharmaceutical ingredients manufactured at a production facility of Kunshan Chemical and Pharmaceutical Co. for violation of good manufacturing practices, according to an FDA warning letter issued Sept. 6, 2007.

House and Senate leaders finally agreed on compromise legislation to renew prescription user fees, just a few days before the funding program was set to expire.

Company and People Notes: Catalent expands Bolton, UK, warehouse; Biotica appoints Edward E. Hodgkin as CEO and director; more.

Pfizer plans to cease all remaining manufacturing operations at its facility in Sandwich, Kent, United Kingdom. The closure will result in the loss of approximately 420 jobs, phased over the next two years, according to a company release

Bayer Schering Pharma officially completed the acquisition of Novartis?s biologics manufacturing facility in Emeryville, California.

US Food and Drug Administration Commissioner Andrew von Eschenbach warned agency employees last Friday that 2,000 layoff notices could be coming as early as Sept. 21.

454 Life Sciences, part of Roche, and researchers at Columbia University identified a virus associated with the deaths of 2.4 million honey bee colonies.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) introduced the Physician Payments Sunshine Act to require pharmaceutical and biologics manufacturers to report the payments, gifts, honoraria, and trips they give to doctors.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States.

The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in a 220–175 vote.

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.

Early this month, Congress is expected to debate what some companies are calling the most significant changes to the United States patent system in 50 years.

A team of researchers from the University of Idaho and Seoul National University have designed a potential drug delivery system by coating silica nanowires with the protein fibronectin.

The US Food and Drug Administration issued a draft guidance, Pharmacogenomic Data Submissions Companion Guidance to be used as a companion to an earlier guidance, Pharmacogenomic Data Submissions, which was issued in March 2005.

Ranbaxy Laboratories has gained approvals from the US Food and Drug Administation to manufacture and market galantamine hydrobromide tablets and carvedilol tablets.

Company and People Notes: SAFC Expands in Wisconsin, Amgen Reduces Rhode Island Staff, More.