Life Technologies snaps up BioTrove; PolyMedix raising $21M for trials;

> Life Technologies is buying up Woburn, MA-based BioTrove, a research equipment supplier best know for its OpenArray platform, which can perform 3,000 gene expression and genotyping assays at a time. Release

> Radnor, PA-based PolyMedix plans to raise up to $21 million in an offering designed to raise money for the mid-stage development of two drug candidates next year. Report

> Smith & Nephew has agreed to put up $21 million in an initial payment for most of the assets of Nucryst Pharmaceuticals, which makes the the Acticoat dressing portfolio for its wound management products. Report

> The FDA is considering a move to outsource the annual review of antibiotics effectiveness to the Clinical and Laboratory Standards Institute, spurring some criticism from lawmakers that members of an agency advisory committee have close ties to CLSI. Story

> Antares Pharma has inked a license and asset purchase agreement with Ferring International Center S.A. that gives Ferring rights to certain intellectual property relating to Antares' proprietary transdermal gel delivery technology. On closing, Ferring will purchase research equipment and assume responsibility for Antares' leased development facility in Allschwil, Switzerland. A majority of the current employees at the facility will become employees of Ferring. Antares release

> Nasdaq is giving Generex Biotechnology an additional 180 days to become compliant with its listing requirements - getting its share price up past the $1 mark for 10 consecutive trading days. Release

Pharma News

> Yet more debate on whether healthcare reform in the U.S. will help drugmakers, and if so, how much. The industry says not so much. But industry-watching number crunchers tell a different story. Report

> Business reporting is all about numbers--and bigger numbers tend to get more attention. But when it comes to job losses, small numbers can add up to big ones pretty quickly. Report

> Now that Merck CEO Dick Clark has pulled off the third-biggest pharma merger of the year, he has another big job ahead: Getting ready for retirement. Report

> Who's at fault for the slow-to-market H1N1 vaccine? USA Today asked consumers, and more than half of them blamed drug companies. Article

> Novartis is plotting a major advertising campaign to support the launch of its over-the-counter heartburn med Prevacid 24HR. Major as in $200 million worth, the Wall Street Journal reports. 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 Baseline Guide, 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... Researchers at the Karolinska Institutet have discovered a mechanism that controls the brain's ability to create lasting memories. Release

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