Novo eyes India as possible manufacturing hub; Judge tosses sales rep's suit against J&J;

> Novo Nordisk is looking at India as a possible hub for manufacturing insulin for the entire region, beginning with a 26 million vial-capacity facility in partnership with domestic drugmaker Torrent Pharmaceuticals. Report

> Johnson & Johnson won a mid-trial motion to dismiss a high-profile lawsuit filed by a sales rep who claimed she was fired for blowing the whistle on off-label promotions of the company's antipsychotic drug Risperdal. Report

> FDA warned U.K.-based Shire and Japan's Eisai about drug promotions that minimized the risk and overstate the benefits of the former's kidney drug Fosrenol and the latter's blood-disorder remedy Dacogen. Report

> Xanodyne got the FDA nod for Lysteda tablets, the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Release

> Glenmark Pharmaceuticals stock rose as much as 7.7 percent after it settled a lawsuit with U.S.-based Medicis Pharmaceutical over selling generic versions of its skin creams. Report

> Cubist Pharmaceuticals buyout rumors are fueling unusual buying activity on options for the company's stock. Report

> Bayer, Novartis and Sanofi-Aventis all were rated "Buy" in new analyst coverage by Deutsche Bank, which said each company "has the potential for material forecast upgrades." Report

Biotech News

> The news Friday that Jan Lundberg--who championed AstraZeneca's R&D shift from internally-driven programs to collaborations with other pharma companies--has been named Eli Lilly's new chief of drug development carries some significant implications for the pharma giant's big R&D operations. Report

> Human Genome Sciences (HGSI) says the FDA has denied its bid to gain an approval for its anthrax drug, asking for additional information on raxibacumab in a complete response letter. The delay is not a big surprise, given the recent vote by an advisory council to request more data on what benefits the drug provides beyond antibiotics. Report

> Nabi Biopharmaceuticals has wrapped a licensing deal worth potentially more than $540 million with GlaxoSmithKline for its experimental therapy designed to treat nicotine addiction and prevent smokers who kick the habit from tearing open a fresh pack. Report

> Dashing investors' hopes, Poniard this morning revealed that its lead drug, the platinum-based cancer drug picoplatin, failed to hit its primary endpoint in a late-stage trial for advanced small cell lung cancer. That's a bitter disappointment for a developer with little else to focus on. And its stock crashed on the news, diving 78 percent. Report

> Shares of Spherix (SPEX) soared 77 percent this morning after the Bethesda, MD-based developer unveiled a positive set of interim Phase III data for its Type 2 diabetes drug. The developer says it's right on track to wrap the study and file for an approval in 2010. Report

> A cash-strapped Genta announced this morning that a late-stage trial for Genasense failed to show a statistically significant benefit for the co-primary endpoint of progression-free survival, or for secondary endpoints of overall response or disease-control for advanced melanoma, forcing the company to slash close to a third of its staff as it hustles to cut costs and raise new funds. Report

> La Jolla, CA-based Fate Therapeutics has rounded up $30 million in a Series B to help advance its work on a pipeline of stem cell modulators. Report

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. "We started with a very targeted group of users. It literally cut the problem right out. We then began to spread the product across the rest of our domains," says Tom Winston, VP global tech ops. Report

> Dermatology-focused CRO Symbio has tapped e-clinical tools provider DATATRAK for an effort that combines paper-based and electronic trial data. Symbio will use DATATRAK eClinical's hybrid functionality--double data entry and EDC--in a Phase III rescue study for an unnamed client. Report

> Special Report: The top 12 GMP violations. Report

And Finally... Raising good cholesterol can curb cancer risk, new research shows. Report

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.