FDA delays Lumizyme approval as woes mount at troubled Genzyme plant; Alkermes says drug dependence therapy a success in PhIII

> The troubles plaguing Genzyme's Allston Landing facility has spurred the FDA to delay approval of its Pompe disease drug Lumizyme. The agency said this morning that it won't approve the drug until it fixes the problems found at the company's manufacturing center in the Boston area. The agency also reported this morning that it found particles of trash - including steel, rubber and fiber -- in the drugs made at the facility. Story

> Alkermes says that its therapy Vivitrol beat out a placebo for treating opioid drug dependence in a late-stage trial, leaving the company on track to file for an approval. Story 

> CombinatoRx says that regulators indicated that the FDA may not approve Neuromed's pain drug Exalgo. CombinatorRx and Neuromed announced earlier this year that they are merging. Report 

> The FDA has approved Xanodyne's new drug for heavy menstrual bleeding. This is the first non-hormonal therapy for the condition. The main ingredient for the therapy was approved as a therapy for hemophilia back in 1986. Release | Story

> Emergent BioSolutions has bought a 55,000 square foot facility in Baltimore to expand its work on development and testing. Release

> Intent on focusing on its biopharma work, Bristol-Myers Squibb is spinning off its Mead Johnson Nutrition Co.  Story

> FDA staffers say that Xolair, an asthma drug from Roche and Novartis appears to convey a "somewhat modest" set of benefits to children aged 6 to 11. An FDA advisory committee will meet Wednesday to consider whether the drug, already approved for 12 and up, should be given to younger patients. Report

> Belgium's Tigenix has acquired the UK's Orthomimetics, adding a new product that treats damaged joint surfaces and underlying bone defects. Story

> Russia's Pharmasynthez ZAO has struck a deal to fund the development of six of Lipoxen's drug and vaccine candidates. Report

> Apogenix says that the European Medicines Agency adopted a positive opinion on orphan medicinal product designation for the company's lead candidate APG101 for the treatment of Glioblastoma multifome and that it has already been granted orphan drug status by the FDA. Release

Pharma News

> Is pharma hiking prices to recoup on reform? Article

> Genzyme just can't seem to catch a break. Vials of five of its meds for rare diseases may be tainted with bits of rubber, steel, or foreign fibers, the FDA said. Report

> Last week we reported that a debt-refinancing at Mead Johnson yielded $1.75 billion in cash for parent Bristol-Myers Squibb. But that's just a fraction of the some $6.5 billion Bristol could net from a planned spinoff of that nutritionals business.

> Analysts were right about that much-anticipated cholesterol drug study. Abbott Laboratories' Niaspan pill did indeed beat out Merck's Zetia at unclogging arteries, according to study results presented at the American Heart Association meeting yesterday. Niadpan release

Biotech IT News

> Reagents and consumables maker LI-COR has added a new sales channel: the CloudCraze e-commerce application from EDL Consulting. CloudCraze is among the early e-commerce applications included on the Salesforce.com AppExchange. Report

> After completing its acquisition of Worldwide Clinical Research, Clinipace has changed its name to Clinipace Worldwide. The combined company will offer "integrated technology-based clinical research solutions and services," according to an announcement. Report

> An Internet-based resource that aids users in selecting contract organizations--both research- and manufacturing-focused--has been unveiled by SourceSolution. Report

> While 21 CFR Part 11 guidelines on electronic records and electronic signatures remain under review with the ultimate goal of revision, consider the ISPE's GAMP guidance a source of support. GAMP 5 offers a "practical approach to compliance in the meantime," says Sion Wyn of the UK-based IT consultancy Conformity, who has assisted the FDA Part 11 guidance development efforts. Report

> High traffic volume had slowed operations on the InForm EDC platform for a Phase Forward client in China. So the e-clinical tools provider turned to Akamai, the distributed computing platform. Report

> Dermatology-focused CRO Symbio has tapped e-clinical tools provider DATATRAK for an effort that combines paper-based and electronic trial data. Report

And Finally... At a conference last week, FDA Commissioner Dr. Margaret Hamburg vowed to speed up the agency's drug review process, noting that a series of missed PDUFA deadlines were a subject of concern. Article

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