FDA nixes 'one-size-fits-all' biosimilars process; Valeant posts big hike in profits;

@FiercePharma: Dendreon cites CMS review for sales trouble, but The Street's take is more plausible: Cash-flow-conscious oncologists. Article | Follow @FiercePharma

> FDA officials say regulatory approval for biosimilars can't depend on a "one-size-fits-all" process, but on an approach specific to each product. Report

> Valeant Pharmaceutical profits skyrocketed by 66% on strong sales in Europe, Latin America, Canada and Australia. Article

> Generics maker Par Pharmaceutical beat analyst estimates for second-quarter profits, but revenue dropped by 12% to $224.2 million. News

> Mexico's Instituto Bioclon won the FDA nod for Anascorp, the first-ever treatment designed specifically for scorpion stings. FDA release | News

> As Medco Health Solutions stock drops on worries that U.S. antitrust regulators will block the Express Scripts buyout, arbitragers are jumping into the gap. Item

Biotech News

@FierceBiotech: Celgene tackles anemia in $242M development pact with Acceleron. Piece | Follow @FierceBiotech

@JohnCFierce: Bloomberg covers the provenge disaster. Doctors confused about coverage? Really? I'm not buying it. Item | Follow @JohnCFierce

@MaureenFierce: FDA's Woodcock on biosimilars: No "one size fits all" approach. Report | Follow @MaureenFierce

> Tiny French biotech touts success of new hep C vaccine. More

> FDA sketches a complex instruction manual for biosimilars. Story

> Pfizer axes $195M Biotica pact, hands back rights to MS, lupus drugs. Item 

> Tiny trial suffices for FDA approval of scorpion sting antidote. Report 

Manufacturing News

> Musty odor exudes from J&J board report exonerating execs. More

> Pharma slices cargo theft in H1 2011. Report

> FDA foreign force multiplier demo'd in API inspections. Article

> Catalent catches the cold chain wave. News

> Developed world feeling sting of fake drugs. Story

Vaccines News

> FDA delays decision on Pfizer's Prevnar 13. News

> Inviragen forms dengue partnership with IVI. More

> Start-up Vaxxas lands $16.46M for vaccine nanopatch. Article

> Merck, Serum Institute sign pneumococcal vaccine deal. Report

And Finally... SSRI antidepressants may carry more side effects than tricyclics in people over 65. Story

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