Report: FDA blazes ahead of EU in drug approvals; India, Russia, in pharma export pact;

@FiercePharma: Fierce's 2011 warning letters report. Report. Our picks for the top warning letters from the last 12 months. | Follow @FiercePharma

> The FDA has logged the second-highest approval rate for new drugs in a decade this fiscal year, signing off on at least two dozen cancer medicines and other compounds before the regulators in Europe. Story

> Next month, Russia and India will sign a pact to make the pharma exports to Russia easier. "India and Russia signed an MoU last year. Another will be signed in December," said Joint Secretary, Department of Pharmaceuticals, Devendra Chaudhry, while addressing Pharma Summit 20011. Report

> The FDA has given its nod to Endo Pharmaceuticals' ($ENDP) generic version of AstraZeneca's ($AZN) Plendil ER tablets, a hypertension treatment. News

> Lupin Pharmaceuticals has received final approval for its levonorgestrel and ethinyl estradiol tablets 0.1 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg from the FDA. They are generic versions of Teva Women's Health's LoSeasonique tablets. Item

> Former Schottenfeld Group trader David Plate has been sentenced to three years probation and 6 months house arrest for his role in the largest insider-trading case in history. Plate, who pleaded guilty to trading on confidential information about Axcan Pharma, could have gotten up to 25 years in prison. But he cooperated with prosecutors, leading to a lighter sentence. "Your cooperation was substantial and you were a very important witness at the trial," U.S. District Judge Richard Sullivan said. Article

Biotech News

@FierceBiotech: Upstart Verastem challenges Wall Street with puzzling $50M IPO. Article | Follow @FierceBiotech

@JohnCFierce: The S1 on Verastem is really kinda funny. The science is unproven, they're still preclinical, and they've only spent a little more than $8M. | Follow @JohnCFierce

@RyanMFierce: ImmunoGen due $1M milestone from Amgen related to $AMGN's IND for an anticancer drug that use's $IMGN's TAP tech. IMGN stock up 44.7% YTD. | Follow @RyanMFierce

@MaureenFierce: Fantastic read: With vaccines, Bill Gates changes the world a second time. Article | Follow @MaureenFierce

> PwC finds mixed bag of VC trends as Q3 cash flow, deal count slows. Story 

> Gates' legendary discipline transforms vaccine effort. Article

> Novo Nordisk stays focused on building Chinese R&D operation. News 

Vaccine News

 

> GSK taps Alnylam tech for faster vaccine production. Report

> Baxter recalls 300K flu vaccines. Article

> Forbes profiles Gates' emergence as vaccine powerhouse. Story

> PATH's Elias, Novartis' Mundel appointed to Gates Foundation positions. News

> Daiichi sets up vaccine R&D unit in Japan. Item

> TapImmune, Aeras team on TB vaccine. Report

 

Manufacturing News

> GSK, Alnylam team to speed vaccine production. Item

> HHS details manufacturing role in drug shortages. News

> FDA details its actions on shortages. Article

> China ready to take on the world. Story

> GSK, Pfizer set HIV drug manufacturing in Russia. Report

And Finally... Pharma meets art. An exhibition of pharma-focused graphic design that opened at the Herb Lubalin Study Center at Cooper Union looks visual trends and features pieces from as far back as 1898 and as recently as this year. Item

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