FDA: Antidepressant suicide risk varies with age; Sun Pharma nabs OK for Eloxatin copy;

> People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an FDA analysis showed. Report [1]

> Shares in Sun Pharmaceutical rose more than 3 percent after the Indian drugmaker got FDA approval to launch two generics, including a version of Sanofi-Aventis' cancer drug Eloxatin. Report [2]

> Sanofi-Aventis confirmed its 2009 guidance even after generic copies of its Eloxatin drug were approved in the U.S. Report [3]

> AstraZeneca has bought rights to Forest Laboratories' new antibiotic drug ceftaroline, boosting the Anglo-Swedish drugmaker's presence in the anti-infectives market. Report [4]

> Schering-Plough settled patent litigation with Orchid Chemicals & Pharmaceuticals related to generic versions of its allergy medication, Clarinex. Report [5]

> Wyeth said U.S. regulators will take three months longer than expected to review Prevnar 13, a more-protective new formulation of its Prevnar vaccine used to prevent pneumococcal disease in infants and toddlers. Report [6]

> Amgen's osteoporosis drug denosumab prevented fractures and strengthened bones in men taking hormone therapy for prostate cancer, according to a study released as U.S. advisers consider whether to recommend the treatment's approval for sale. Report [7]

Biotech News

> Just two days ahead of a crucial expert panel review [8] of Amgen's blockbuster bone drug denosumab, a new study revealed that the drug reduced spinal fractures in 62 percent of prostate cancer victims when compared to a placebo. And the therapy also increased mineral density in bones. Report [9]

> Shares of Javelin Pharmaceuticals tanked Tuesday morning after investors got wind of mixed Phase III data for its post-operative pain drug Ereska. Report [10]

> With an experimental antiviral in mid-stage clinical trials, Research Triangle Park, NC-based Chimerix has raised $16.1 million from a Series E. Canaan Partners, Alta Partners, Sanderling Ventures and Asset Management Company participated in this insider round. Report [11]

> Nashville-based Cumberland Pharmaceuticals has broken a nearly two-year long drought of biopharma IPOs, raising $85 million in a public offering. Cumberland had expected to sell its shares for $19 to $21 each, but settled for $17. Report [12]

Manufacturing News

> Custom manufacturing of formulations and intermediate drugs in India is projected to grow at a rate of 43 percent, three times the projected global rate. So says a report from the Organization of Pharmaceutical Producers of India and consultancy Ernst & Young, based on 50 survey respondents from 30 pharmaceutical companies in the US, Europe and Asia. Report [13]

> The FDA is cracking down on websites offering swine flu remedies. As of last week, Hamburg says, "the FDA had issued 65 warning letters to offending websites, covering 125 fraudulent products." Some 80 percent of the websites have complied with the FDA's requests, and by mid-June, the rate at which new websites were cropping up had slowed from ten per day to about two per week. Report [14]

> Leading by example on her promise of transparency at the FDA, Commissioner Margaret Hamburg spoke publicly on her recent actions and plans for a strong FDA. Speaking from prepared remarks at the Food and Drug Law Institute in Washington last week, she outlined the first six steps toward that objective. Report [15]

And Finally... New research shows that widespread general use of fluoroquinolone antibiotics may be creating a strain of fluoroquinolone-resistant TB. Release [16]