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Home » Newsletters » BioWorld

BioWorld

Feb. 10, 2012

View Archived Issues

Draft Guidances Begin to Pave the Biosimilar Road

The biosimilar pathway is beginning to take shape now that the FDA has released a package of draft guidances to pave the way. Read More

Altheos Boosts Series A by $12.5M for Glaucoma Trial

Altheos Inc., of South San Francisco, raised an additional $12.5 million in its Series A financing and will be cashing the check immediately to support a Phase IIa trial of its glaucoma candidate, which recently dosed its first patient. Read More

Ready for 'Pivotal' Year, Array Adds $52M in Public Offering

With data from at least seven clinical trials due this year, along with a Phase III go/no-go decision on its most advanced partnered program, Array Biopharma Inc. is bolstering its cash position with a $52 million public offering. Read More

Other News To Note

• Astex Pharmaceuticals Inc., of Dublin, Calif., said the FDA's Oncologic Drugs Advisory Committee voted 10 to 3, with one abstention, that data provided for Dacogen (decitabine) did not support a favorable benefit/risk profile in acute myeloid leukemia patients, ages 65 and older, who are not considered candidates for induction therapy. The FDA, which is set to review the supplemental new drug application (sNDA) by March 6, generally follows the recommendation of its advisory panels though it is not obligated to do so. Read More

Stock Movers

Read More

Clinic Roundup

• Moberg Derma AB, of Stockholm, Sweden, said its Phase II trial of MOB-015, a topical drug for nail fungus, is unlikely to produce results sufficient for out-licensing, and additional studies likely will be needed before Phase III. The assessment was based on an interim analysis; full data are expected by the end of the year. Read More

Earnings Roundup

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., reported that 2011 net sales of Soliris (eculizumab) grew 45 percent, to $783 million, compared to $541 million in 2010. The company's 2011 non-GAAP net income increased 59 percent to $266.1 million, or $1.38 per share, compared to 2010 non-GAAP net income of $167.3 million, or 89 cents per share, while 2011 GAAP net income increased 81 percent to $175.3 million, or 91 cents per share, compared to 2010 GAAP net income of $97 million, or 52 cents per share. Read More

Pharma: Clinic Roundup

• Grupo Ferrer International SA, of Barcelona, Spain, said lorediplon was well tolerated and demonstrated efficacy comparable to or in excess of Ambien (zolpidem, Sanofi SA) in a Phase I insomnia trial. Read More

Pharma: Other News To Note

• Merck and Co. Inc., of Whitehouse Station, N.J., warned U.S. physicians that a recent pharmacokinetic study in healthy volunteers showed hepatitis C protease inhibitor Victrelis (boceprevir) may reduce the efficacy of ritonavir-boosted HIV protease inhibitors. Read More

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