@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