Patricia Van Arnum

The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that drew criticism from both sectors of the pharmaceutical industry.

The US government outlines its strategy against counterfeiting and intellectual-property infringement, including ways to better secure the pharmaceutical supply chain.

Led by sustainability efforts by Walmart, a new tool emerges for quickly evaluating the environmental and human-health profile of formulated products.

Acumen Fund, a nonprofit venture-capital fund, uses patient capital to build economically sustainable businesses involved in poverty alleviation.

Nanotechnology is an important area of drug and biomedical research, and advancing nano-analysis is crucial for its further development.

Excipient manufacturers expand their products, services, manufacturing capacity, and technology positions.

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.

The US International Trade Commission (USITC), an independent federal agency, is initiating a review of more than 700 pharmaceutical products and chemical intermediates to be considered for duty elimination.

The Critical Path Institute announced last week the formation of the Coalition Against Major Diseases, a formal consortium of pharmaceutical companies, research foundations, patient-advocacy groups, health organizations, and regulatory agencies, which will share information on clinical trials for treatments for neurodegenerative diseases.

Pfizer (New York) is voluntarily recalling metronidazole, ciprofloxacin, and ondansetron intravenous products because of the presence of floating matter and non-sterility discovered by the manufacturer Claris Lifesciences.

The pharmaceutical industry provided immediate aid for the relief efforts in Haiti and is proceeding with plans to assist with long-term recovery.

FDA issues draft proposals on ways to improve its disclosure on information relating to import procedures, inspections, and Warning Letters.

The American Association for the Advancement of Science rolls out several initiatives to increase partnerships and communication on human rights between scientific groups and between scientific and human rights groups.

The US House of Representatives held hearings last week to gain testimony on the potential benefits and risks associated with synthetic biology and synthetic genomics.

CROs and CMOs adapt their business models and capabilities to meet sponsor companies' need to reduce costs and accelerate development time.

Puerto Rico, long a mainstay of solid-dosage manufacturing, intensifies efforts in biopharmaceutical manufacturing and research and development.

A PharmTech forum to discuss the industry's efforts in corporate social responsibility and sustainability.

Signaling its interest to strengthen its presence in emerging markets, Abbott (Abbott Park, IL) has agreed to acquire Piramal Healthcare Ltd.'s (Mumbai, India) Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion.

Pfizer (New York) announced this week plans to reconfigure its global manufacturing network as part of its integration following its $68-billion acquisition of Wyeth (Madison, NJ) in 2009.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

The traditional lines of demarcation between innovator-drug and generic-drug companies are blurring as each sector responds to changing industry fundamentals.

Further consolidation, slowing growth in established markets, and growth in smaller and emerging markets are important factors influencing the direction of the global generic-drug market.

Chemocatalysis and biocatalysis are important elements of an effective strategy for improving yield and stereoselectivty.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The biopharmaceutical company Genzyme (Cambridge, MA) provided an update on its manufacturing operations following the issuance of a draft consent decree by the FDA regarding the company?s Allston Landing, Massachusetts, manufacturing plant.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

The Society of Chemical Manufacturers and Affiliates is raising concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act.

sanofi-aventis outlined an investment plan for adapting its chemical and biotechnology manufacturing facilities in France during the next four years.