News

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.

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.

After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

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...

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.