News

The US Food and Drug Administration posted its rates for user fees for fiscal year 2008, effective Oct. 1, 2007 through Sept. 30, 2008.

The US Food and Drug Administration sent Med-South Pharmacy a Warning Letter for producing large volumes of betamethasone acetate?betamethasone sodium phosphate without following current good manufacturing practices (CGMPs).

Company and People Notes: Orexo acquires Biolipox, Avalon cofounder resigns, more...

Pfizer decided to stop investing in ?Exubera? (inhaled insulin), a product that had been considered a potential blockbuster drug.

GlaxoSmithKline and Synta Pharmaceuticals agreed to jointly develop and commercialize STA-4783. The drug is an injectable, small-molecule, oxidative stress inducer for treating metastatic melanoma that is entering Phase III clinical development.

CPhI Worldwide, the large trade show of suppliers of active pharmaceutical ingredients (APIs), intermediates, and excipients, took on a decidedly international presence.

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

Company and People Notes: Novartis and MIT to study continuous processing, GSK appoints Andrew Witty as CEO, more.

The US Food and Drug Administration will hold a public meeting on November 14, 2007 to solicit comments about the proposed behind-the-counter (BTC) availability of drugs.

The European Fine Chemicals Group (EFCG) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week.

The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in FY2008.

The public gives mixed reviews to the pharmaceutical industry and the US Food and Drug Administration for issues such as drug safety, timeliness in bringing drugs to market, and their role in addressing the high costs of drugs.

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.

Change is inevitable, as is contract manufacturing. But which companies will survive the drifts?

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.

Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.

Courts are denying the terminally ill access to experimental drugs, leaving many with no options.

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.