Biogen gets regulators to accept NDA, MAA for BG-12; FDA green lights stem cell study in ALS;

 @FierceBiotech: First "cross-kingdom" vaccine effective in Phase I. Report | Follow @FierceBiotech

 @RyanMFierce: Check out Mark Leuchtenberger's scheduled IPO for Rib-X, an antibiotics developer, after price cut. More | Follow @RyanMFierce

> The FDA and EMA have accepted Biogen Idec's ($BIIB) applications for multiple sclerosis pill BG-12. The FDA granted a standard review for the drug, which Biogen aims to launch on the U.S. market next year. Item

> U.S. regulators have given a green light for three patients with ALS to receive a second dose of stem cells after the first dose was given to patients safely. Release

> Pulmotect has pulled in a $7.1 million grant from the Cancer Prevention & Research Institute of Texas to study a product for protecting patients on chemotherapy from infections. Announcement

Pharma News

 @FiercePharma: Here's Glaxo's take on the official launch of hostile HGS bid. More | Follow @FiercePharma

> DSM panel holds firm on new autism diagnosis, ditches 2 other revisions. News

> With generics horde advancing, Pfizer gives up Lipitor push. Report

> Roche's Tarceva wins NICE nod for first-line use. Article

> Glaxo can nail HGS buy with slightly bigger bid, analysts say. Item

Medical Devices News

 @FierceMedDev: Finland's ArcDia grabs $3.5M in new financing to fuel growth of its respiratory infection diagnostic test. Item | Follow @FierceMedDev

> FDA looks to reduce kids' radiation exposure in draft guidance. News

> George Will jumps on the anti-device tax bandwagon. Article

> Report: Bad lifestyles fuel diagnostics boom in emerging markets. Story

> Study: Worriers, negative folks fair worse with ICDs. Report

CRO News

 @NesaNFierce: Monkey see, monkey ... don't. MPI Research is getting lots of flack from the USDA and an animal rights group over animal mistreatment. Article | Follow @NesaNFierce

> CMO service pacts needed for success, Baxter says. News

> Kythera seeks $250,000 from Cetero for development delays. Story

> AMRI sees Q1 drops, but maintains positive financial outlook for 2012. More

> Covance sees early development losses, closes Arizona lab. Item

Pharma Manufacturing News

 @EricPFierce: Ranbaxy's stellar first quarter shows the upside of having pharma manufacturing operations tip top. Report | Follow @EricPFierce

> 12-year-old consent decree lifted from Abbott. Story

> FDA critical of Genentech's Avastin production. Article

> Pfizer may announce $129M expansion in Belgium. More

> Patheon exiting most manufacturing at U.K. plant. Item

Vaccines News

> MMR and autism: Italy's courts get involved. Report

> Study: Further insight into Merck HIV vax infection increase. Article

> Pneumococcal vax cuts deaths, but cases tripled. News

> Swine flu vax could offer universal flu protection. Story

And Finally… A cell therapy reversed Type 1 diabetes in a mouse study, giving researchers hope for a cure in humans. Item

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