Pfizer pays $17M after Venezuelan audit; Perrigo to shift some API-making to India;

> Pfizer's Venezuelan unit paid 36.59 million bolivars ($17 million) in back taxes after auditors questioned its transfer pricing methodology, Venezuela's tax service said. Report [1]

> Pharmaceutical manufacturer Perrigo has taken a majority stake in Vedants Drugs and Fine Chemicals in a move that will shift production of some of its active pharmaceutical ingredients to India. Report [2]

> Generic drugs accounted for more than half the 2008 prescriptions and about one-quarter of 2008 drug sales in the Canadian pharmaceutical market. Release [3]

> Abbott Laboratories, which lost the largest verdict in the history of patent litigation in June, was sued by a New Jersey doctor who claims the company infringed his patent used for heart devices. Report [4]

> The FDA wants to amend postmarket safety reporting to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. Report [5]

> Hungarian drug producer Egis said chief executive Agnes Gal had resigned effective September 30, due to personal reasons, and will be succeeded by Istvan Hodasz. Report [6]

Biotech News

> In a fresh sign that everything pandemic-related gets swiftly shoved into the biotech spotlight these days, shares of Medicago have been buoyed by its announcement that Canadian regulators have cleared an early-stage human trial of its bird flu vaccine. Report [7]

> Here's an interesting twist on a big problem in the discovery field: Is the biopharma industry's recent weakness at gaining regulatory approvals for new drugs more about the inability of their therapies to work as intended, or is an enhanced placebo effect to blame? Report [8]

> The Telegraph reports that rumors are beginning to pop up that GlaxoSmithKline is preparing to make a $30-a-share offer to buy up the newly hot stock of Human Genome Sciences. Report [9]

> Shares of Protalix BioTherapeutics surged another 12 percent this morning after the developer announced that the FDA had put its closely-watched therapy for Gaucher disease on the agency's fast track. Report [10]

> With an expert panel review looming at the FDA for its cancer drug romidepsin, an HDAC inhibitor, Cambridge, MA-based Gloucester Pharmaceuticals announced that it has raised $29 million in a fourth round of venture capital. Report [11]

Manufacturing News

> Time spent gathering and analyzing data from multiple sources is the biggest challenge facing both small/medium and large drug makers, say respondents to a recent survey. In addition, more than 60 percent of 538 manufacturing professional respondents report "moderate" or "significant" variability in their manufacturing processes. Report [12]

> It's been a good summer for drug theft. Mylan subsidiary Dey announced last Wednesday the theft of two lots of its Albuterol sulfate inhalation unit-dose vials. GlaxoSmithKline announced Monday that two lots of Advair Diskus medication were stolen earlier this month from the company's distribution facility near Richmond, VA, while awaiting shipment to retail pharmacies. Report [13]

> Attempting to bust the oft-frustrating venture-funded biotech business model, University of Pittsburgh Medical Center CEO Jeffrey Romoff testified before congress last week, proposing a public/private model for vaccine production. Report [14]

And Finally... A new report suggests that tamoxifen, a drug widely used to prevent the recurrence of breast cancer, may have a rare but dangerous side effect: increasing the odds that long-term users may develop an uncommon but aggressive new tumor. Report [15]