The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office (GAO) that was released this week.

Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more...

The US Food and Drug Administration is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week.

The global API market has expanded from $69 billion in 2004 to more than $90 billion in 2008, according to a report from the Italian Chemical Pharmaceutical Association (CPA); in particular, the report noted a rapid growth rate for generic APIs.

Cheaper generic pharmaceuticals, emboldened by US law and patent challenges, restrict novel future innovations.

US-based CRO, Health Decisions, hopes to raise the efficacy standards for complex studies and help companies get products to market faster by establishing an international network of CROs.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more...

Following the completion of its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) began joint operations of the combined company last week.

The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus.

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the October 2009 edition from Emerson and Minitab.

Economic pressures are forcing pharmaceutical manufacturers to look for ways to become more competitive. Many companies realize that they must reduce operating costs but maintain or improve product quality.

ISP Pharmaceuticals is embarking on a Drug Solubility Initiative to support pharma companies working with poorly soluble drug actives.

SAFC Pharma has completed a $12-million expansion to its contract manufacturing facility in Carlsbad (CA, USA), which will expand the company's services for its later phase and commercial clients.

For the first time, cancer treatments accounted for 5% of overall drug spending in the first half of 2009, said Medco Health Solutions in a press release last week.

Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more...

IMS Health delivered some good news last week with its updated pharmaceutical market forecast.

Also, USAID and USP launch counterfeiting public service campaign in Cambodia.

The US Food and Drug Administration issued an alert to healthcare professionals of a change in heparin manufacturing that is expected to decrease the drug's potency.

Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting...

The 2009 Nobel Prize in Physiology or Medicine was awarded to three US researchers for the discovery of how chromosomes are protected from degradation by telomeres and the enzyme telomerase during cell division.

GlaxoSmithKline (London), Novartis (Basel, Switzerland), sanofi Aventis (Paris), and Baxter International (Deerfield, IL) recently provided updates as to the development, manufacture, or shipment of pandemic (H1NI) vaccines.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more...

AAPS President offers hope and solutions for the industry's challenging future.

Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.