> Generics maker Perrigo is hiring to fill 60 positions at its Michigan headquarters and production sites. Report
> A third attempt by an American Medical Association ethics council asking physicians and medical institutions to curb industry funding for professional educational activities was rebuffed. Report
> Hungarian drugmaker Richter Gedeon raised its Russian, U.S. and domestic sales targets but left the overall group revenue target steady due to weakness in other markets. Report
> The high court in Madras, India, ordered Zydus Cadila not to sell its antidepressant drug Venz (a version of venlafaxine) because of a trademark complaint from Sun Pharmaceutical Industries. Report
> AstraZeneca's board will consider in January whether to reintroduce share buybacks after "an unusually good" 2009, the company's chief executive said. Report
Biotech News
> GlaxoSmithKline finally won an approval for its H1N1 vaccine from the FDA, but don't look for any big shipments to the U.S. The regulatory approval clears the way for Glaxo to deliver only 7.6 million doses of the swine flu shot in December. Report
> Spain's Cellerix has gathered a group of investors--including two Big Pharma funds--willing to double down on its development of promising adult stem cell therapies. Report
> You won't have to wait very long before Sanofi-Aventis is back with more news about biotech tie-ups. Sanofi CEO Chris Viehbacher has made new R&D pacts with drug developers a top priority since taking over the top job. And he was back in the Boston biotech hub this week to make that point perfectly clear. Report
> Sanofi-Aventis's warm embrace of Regeneron's antibody work has turned into a bear hug. The drug giant is extending its two-year-old pact to develop new therapeutic antibodies with a commitment to pay more than a billion dollars to Regeneron over eight years. Report
> Alexandria Real Estate is best known in biotech circles for its U.S. developments. But an Indian newspaper says that the developer is laying out plans for a sprawling R&D complex and life science incubator on 25 acres next to Tata Motors' Nano project in Sanand. Report
> John LaMattina, Pfizer's former R&D chief, has made the leap into the venture field, joining PureTech Ventures as a senior partner. After putting in 30 years at the drug giant, LaMattina retired as president of global R&D at Pfizer about two years ago. But he was lured to PureTech by its start-up model: finding breakthrough technologies and then building a biotech company around it. Report
Manufacturing News
> Arzerra, the recently approved monoclonal antibody treatment for leukemia from GlaxoSmithKline and Genmab, will be manufactured by Lonza. The Swiss-based contract manufacturer performed process development and cGMP manufacturing services to support the drug's licensure. Report
> Despite distribution and manufacturing delays, the H1N1 vaccine situation could have been a lot worse. An important step in pandemic preparedness has averted what would surely have been a supply strangler just a few years ago--egg availability. Report
> ISPE has released Oral Solid Dosage (OSD) Forms BaselineGuide, Second Edition, at its annual meeting in San Diego this week. The FDA-reviewed publication updates content from the original work to current industry standards, practices, and regulatory requirements. Report
> There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of ICH [the quality risk management guidance of the International Conference on Harmonization] has a good toolbox," she adds. Report
> Drug regulators in the U.S and Europe are becoming fast friends. Officials are talking more, according to regulator-panelists at a town hall gathering held this week at the ISPE annual meeting in San Diego. They are recognizing that they follow the same path to drug approvals despite differences in some of the methods used. Report
> Lawyers are providing a non-regulatory reason for manufacturers to comply with good manufacturing practices. "The rules haven't changed. GMPs are GMPs," says Philip Katz, a partner at Hogan & Hartson. "What's changed are the stakes for noncompliance." Report
And Finally ... A diet high in fructose increases the risk of developing high blood pressure, a new study has found. Report