Pharmaxis drug promising in cystic fibrosis trial; Novavax swine flu vax advances to second stage;

> Australia's Pharmaxis says its drug Bronchitil significantly improved lung function in a study involving 170 patients with cystic fibrosis. The data helped drive its shares up 11 percent. The effect is well above what we have seen in trial results from anything that is on market or under development," noted analyst Graeme Wald. "Bronchitol can change the course of cystic fibrosis." Report

> Shire's Replagal produced promising results for a study involving patients with Fabry disease. "These long-term, ‘real-life' registry data confirm the hopes raised by short-term clinical trials," study author Atul Mehta said in a statement. "Enzyme replacement therapy has the potential to prolong quality life in this often fatal illness." Report

> The first phase of Novavax's clinical trial for a new swine flu vaccine went well, demonstrating promising safety results and sending its shares up eight percent. An independent panel recommended that the trial - which is being conducted with Mexico's Avimex Labs--proceed into its second phase. Novavax is advancing new vaccines made with its VLP technology, which promises significant improvements over manufacturing methods in use today. Story

> Merck is extending its research pact with Switzerland's Addex Pharmaceuticals, chipping in an extra $1.8 million for a collaboration that focuses on a key receptor that could play a role in treating Parkinson's disease. Story

> Pacira Pharmaceuticals announced that its second Phase III placebo controlled study of Exparel (DepoBupivacaine) met its primary endpoint. Pacira release

> Galenea Corp. and Otsuka Pharmaceutical announced the further extension of their research and development collaboration through 2011. Release

Pharma News

> Pfizer's teaming up with Protalix BioTherapeutics on a Gaucher's disease drug certainly signals the company's interest in niche treatments for rare diseases. But it also is a bad sign for pharma sales reps far and wide, BNet Pharma points out. Article

> Teva Pharmaceutical Industries has officially become a thorn in Amgen's side. The Israeli generics giant has asked FDA to approve its biotech drug designed to increase white blood cells in cancer patients--designed to be biosimilar to Amgen's $1 billion-plus Neupogen. Report

> Now even the Senate is backing away from that $80 billion healthcare reform deal with pharma. And not just anybody in the Senate, either: Finance Committee Chairman Max Baucus, the very senator who spearheaded negotiation of that cost-cutting pledge. Report

> The world may be storming Japan's drug market, but homegrown Takeda Pharmaceuticals is turning to India for growth. Takeda report

> A week after testing his "let's follow the rules" message in the U.K., Pfizer chief Jeffrey Kindler has brought it home to the U.S. And this time, he addressed the elephant in the room directly: The little matter of his company's record-breaking off-label marketing settlement with the Justice Department that included a felony plea for one of its subsidiaries. Pfizer article

Manufacturing News

> The FDA's mighty efforts to become a more transparent government agency, beginning with a transparency task force, convened in June, are yielding results, says blogger Mark Senak. Report

> FDA reviewers can look forward to a break in their daily routine for education on advanced pharmaceutical manufacturing and technology. Report

> Japanese drug officials are visiting Canada following GlaxoSmithKline's advice to the Great White North to hold the remaining 15,000 doses of a batch of swine flu vaccine. Article

> "Do not enter into supply agreements with companies that do not meet acceptable standards, and terminate agreements with companies that do not maintain acceptable standards." So says Gerry Migliaccio, senior VP for global manufacturing at Pfizer, in a Pharmaceutical Technology interview. Report

> The on-again, off-again efforts of the FDA's office of combination products are back on again. Report

> Cross-contamination has tripped up API maker ZaCh Systems in France. The company was cited in an October warning letter for lacking procedures necessary to prevent cross-contamination. Report

And Finally... LA officials are worried that an influx of holiday travelers this month may ignite a new wave of swine flu cases. Report

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