Pharmaceutical Technology Editors

The US Food and Drug Administration has issued Ben Venue Laboratories a Warning Letter resulting from CGMP deviations found during an inspection of the company?s ?Propofol? injectable emulsion manufacturing facility earlier this year.

Company and People Notes: Cambridge Major Labs acquires ChemShop; Helix BioPharma restructures senior positions, more.

At the opening session of the American Association of Pharmaceutical Scientists? 2007 Annual Meeting and Exposition, President Gene Fiese, PhD, presented awards to researchers commemorating their contributions to the pharmaceutical sciences

Company and People Notes: BASF raises prices on excipients; Verus Pharmaceuticals appoints president and CEO; more.

Submitting a safety update to European regulators, Novartis provided data showing its 100-mg once-daily dose of ?Galvus? (vidagliptin), an oral type 2 diabetes treatment, has more frequent liver enzyme elevations in patients than its already approved 50-mg once- and twice-daily doses.

Pfizer's Lipitor patent revoked in Germany, promotions at Charles River Labs, more.

Wyeth Consumer Healthcare launched a voluntary recall and replacement program for US retail outlets that sell several ?Robitussin? and ?Children?s Dimetapp Cold and Chest Congestion? products.

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.

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Company Notes: Gibraltar expands facilities; Allozyne appoints new president and CEO, more.

The US Food and Drug Administration announced the formation of the Pediatric Review Committee to help ensure quality and consistency across the agency.

In accordance with the US Food and Drug Administration Amendments Act of 2007, FDA is asking companies to notify the agency within 30 days whether they intend to participate in FDA?s direct-to-consumer user-fee program during fiscal year 2008.

Company and People Notes: ImClone, BMS, and Merck form agreement; CRI Worldwide names new CEO, more.

Medical students are participating in various activities this week to persuade medical schools to shield their campuses from the influence of pharmaceutical marketing as part of ?National PharmFree Week.?

Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting, life-sustaining, or for prevention of certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.

On behalf of manufacturers of over-the-counter (OTC) infant cough and cold medications, the Consumer Healthcare Products Association announced a voluntary withdrawal of products intended for use in children under age 2.

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...

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.

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).

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.

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