Orthofix slapped with another class-action lawsuit; NxStage medical urges CMS payment reform;

@FierceMedDev: Siemens Dx test panel recall draws FDA's "most serious" label. Story | Follow @FierceMedDev

@MarkHFierce: FierceDiagnostics has some great new stories--check them out! FierceDiagnostics | Follow @MarkHFierce

@MichaelGFierce: Laser system gives clear, real-time image of brain tumors for surgery. Item | Follow @MichaelGFierce

> Orthofix International ($OFIX), barely past a 2012 Medicare kickback scandal, got hit with another class-action lawsuit involving its need to restate more than two years of revenue. Item

> NxStage Medical ($NXTM) is urging the Centers for Medicare and Medicaid Services to reform what it says are "insufficient and inequitable" payments for home hemodialysis training. Release

> Ireland's Apica Cardiovascular nailed down a CE mark for its Access, Stabilization and Closure System, a surgical tool designed to aid transcatheter aortic valve implantation procedures. Item

> Abyrx of Irvington, NY, gained the FDA's 510(k) clearance for its new resorbable hemostatic bone putty. Item

> Devon Medical, a device company specializing in wound care, has hired industry vet Chip Ross as its new president. Item

> Canada's Nordion ($NDZ), which provides isotopes for medical imaging, reported a big jump in third-quarter profit, thanks to the sale of its targeted therapies business. Story

> Slashing the time it takes to treat heart-attack patients after they arrive at the hospital hasn't reduced deaths, according to new research published in the New England Journal of Medicine. Story

Biotech News

@FierceBiotech: Troubled Rigel axes 30 staffers as it maps a comeback R&D strategy. Story | Follow @FierceBiotech

@JohnCFierce: Trending on FierceBiotech: In big setback, GlaxoSmithKline's cancer immunotherapy MAGE-A3 flunks PhIII goal. Article | Follow @JohnCFierce

@RyanMFierce: In growing diabetes market, Sanofi looks beyond iPhone for mobile glucose testing. More from FierceBiotechIT | Follow @RyanMFierce

@EmilyMFierce: Matter: A Catalog for all the World's Viruses? More from the NY Times | Follow @EmilyMFierce

> Otonomy banks $46M VC round for PhIII programs on inner-ear drugs. Story

> MacroGenics trumpets cancer immunotherapies in $60M IPO pitch. Article

> Otsuka bags Astex cancer drug programs and R&D for $886M. News

> Sanofi nabs U.S. rights to a safer aspirin in $35M Pozen deal. Report

Pharma News

@FiercePharma: ICYMI: Yesterday's top story: Onyx CEO will score $58M on Amgen deal. Other execs also to collect millions. More | Follow @FiercePharma

@EricPFierce: New AstraZeneca aseptic manufacturing facility at Macclesfield would add 3 dozen jobs. News | Follow @EricPFierce

@CarlyHFierce: From FierceVaccines: Will increased #flushot options confuse patients? Story | Follow @CarlyHFierce

> With $886M Astex buy, Otsuka joins Japanese rivals in overseas dealmaking. More

> Eli Lilly expects no clarity on Alimta monopoly till 2014. Story

> EU leaders slam China for targeting foreign drugmakers. Article

Pharma Manufacturing News

> PhRMA, BIO, GPhA lose suit against drug-disposal law. More

> AstraZeneca plant expansion would add 3 dozen jobs. Story

> Mylan expansions roll on. Article

> Plant in Spain gets warning letter for failing to test products. News

> Merck plant gets FDA nod for bulk varicella. Report

> Last-mile thefts grow dramatically this year. Item

Vaccines News

> PATH defends itself against Indian criticisms of HPV project. Story

> CDC reports strong uptake of Merck's Gardasil in boys. More

> Researchers promise renewed push to build on Thai HIV trial success. Article

> Doctors warn plethora of flu vaccines may confuse patients. News

> FDA clears Merck plant to produce shingles vaccine ingredient. Report

> Israel may drop planned HPV vaccination program. Item

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