News

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

The US Food and Drug Administration posted on its website a Warning Letter it sent to Wyeth Pharmaceuticals regarding a journal advertisement for the company?s ?Effexor XR? antidepressant.

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

Company and People Notes: Eisai Acquires MGI Pharma, Ceregene Names CEO, More

The scientific demands on the US Food and Drug Administration far exceed its capacity to respond, according to a recent report by the Subcommittee on Science and Technology of the FDA Science Board.

Bristol-Myers Squibb outlined a comprehensive review of its operations and a strategy to improve top-line growth, a plan that involves staff reductions and rationalization of its manufacturing plants.

Company and People Notes: Boehringer Ingelheim Expands Facility, Regulus Therapeutics Names President and CEO, More

Pfizer?s restructuring plans reportedly include major investments in outsourced manufacturing operations, production facility closures, and personnel reductions.

The number of new molecular entities approved by the US Food and Drug Administration is down this year as the pharmaeutical industry continues to face an innovation drought.

Big Pharma's strategic push into biologics and continuing restructuring are among the highlights for 2007.

Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.

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

Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.

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.

GlaxoSmithKline agreed to acquire Reliant Pharmaceuticals for $1.65 billion in cash.

Sanofi-aventis entered into an agreement with Chinese authorities allowing Sanofi to construct a vaccine-manufacturing plant in Shenzhen municipality.

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

Eli Lilly plans to invest $100 million in research and development in China over the next five years through Lilly Asian Ventures, a Lilly-owned venture capital firm that makes investments in Asia.

Growth in the global pharmaceutical industry is expected to slow in 2008, marked by slowing growth in the United States and other major markets. At the same time, pharmaceutical industry growth in emerging markets is expected to reach double-digits, although these markets still represent a small percentage of global pharmaceutical sales.

The US Government Accountability Office issued findings that are largely critical of the US Food and Drug Administration in managing its inspections of foreign drug-manufacturing facilities.

The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States.

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

The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.

Looking to resolve litigation over Vioxx (rofecoxib), Merck & Co reached an agreement to settle the vast majority of Vioxx claims for $4.85 billion.

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.