FDA staffers again wary of ACS use for J&J's Xarelto; Teva: We'll move 45% of Copaxone users to new formula; Gedeon Richter dismisses talk of Forest buyout;

@FiercePharma: Novo Nordisk eyes IPO for its IT subsidiary, taps new CFO to lead review. Story | Follow @FiercePharma

@TracyStaton: Best-read FiercePharma Tuesday: Merck CEO: We'll decide on animal health, consumer biz by year-end. Story | Follow @TracyStaton

@EricPFierce: McKesson fails to get EU drug distributor Celesio. Some see the miss as a shame for both. Story from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: Drug buyers sue Novo Nordisk over 'wrongful' delays to diabetes generic. Yesterday's story  | Follow @CarlyHFierce

> FDA reviewers expressed reservations about a new use for Johnson & Johnson's ($JNJ) anticoagulant drug Xarelto, saying there's not enough evidence that the drug significantly benefits patients with acute coronary syndrome. Report

> Teva Pharmaceutical Industries ($TEVA) figures it will soon win FDA approval for its thrice-weekly version of the multiple sclerosis treatment Copaxone, and that it can convert 45% of current Copaxone patients to the new formula, despite the latter's patent expiration in May. Report

> Hungary's Gedeon Richter brushed off rumors of a takeover by U.S.-based Forest Laboratories ($FRX), its partner on the antipsychotic drug cariprazine. Report

> Germany's Bayer said it would reintroduce a hormonal acne drug Diane-35 in France, where sales had been suspended for 8 months on safety concerns. Report

> South African entrepreneur Brian Joffe says he's confident that he and other Adcock Ingram shareholders can fend off a takeover bid by Chile-based CFR Pharmaceuticals. Report

> A German court ruled in favor of Novartis ($NVS) in a fight over a copycat version of the Swiss drugmaker's eye treatment Lucentis. Report

Medical Device News

@FierceMedDev: Covidien's ventilator recall gets hit with FDA's 'most serious' Class I label. More | Follow @FierceMedDev

@MarkHFierce: The latest weekly edition of FierceDiagnostics is all ready for you, now with added biomarker coverage. Check it out. Issue | Follow @MarkHFierce

@MichaelGFierce: Roche's delivery method 'shuttles' Alzheimer's drugs past blood-brain barrier. Story from FierceDrugDelivery | Follow @MichaelGFierce

@EmilyWFierce: Qiagen and Exosome inked a Dx development deal to create cancer biomarkers. Yesterday's story | Follow @EmilyWFierce

> Struggling Sequenom's Mayo Clinic deal expands the reach of its prenatal Dx. Story

> Medtronic and Edwards take heart valve rivalry to hospital admins. Report

> Omnibus bill would restore FDA user fees; AdvaMed, MDMA applaud. News

Biotech News

@FierceBiotech: Sanofi launches a new antibiotics effort, teams with Fraunhofer. More | Follow @FierceBiotech

@JohnCFierce: Interesting to see Chelsea Therapeautics win the solid backing of the adcomm. Now back to the FDA, where the weather has been much chillier. Odds on OK? | Follow @JohnCFierce

@DamianFierce: Regeneron, Bayer reach for the old Eylea magic with combo AMD deal. Yesterday's story | Follow @DamianFierce

@EmilyMFierce: Omnibus bill would restore $1B in funding to NIH. Story from FierceBiotech Research | Follow @EmilyMFierce

> Bristol-Myers says it's open to dealmaking in the cancer field. Item

> Aduro's combo cancer vaccine combo posts positive survival benefits. Article

> Billionaire Soon-Shiong ties a $75M knot with Celgene, vows R&D revolution. More

> Chelsea soars after FDA AdCom once again endorses bid to OK Northera. News

Drug Delivery News

> Roche's delivery method 'shuttles' Alzheimer's drugs past the blood-brain barrier. Story

> 'On-off' switch in disguised nanoparticles shows delivery potential. Story

> Cynapsus' sublingual strip for severe Parkinson's reduces side effects in a study. Story

> Global nanomed market, driven by brain delivery, is expected to reach $177B by 2019. Item

> Elixir places first DESolve drug-eluting stent in patient. Article

> Amid RNAi buzz, Arcturus touts positive preclinical results. More

Diagnostics News

> J&J will link with a Seattle Dx outfit on a biomarker discovery program. Story

> Ovarian cancer biomarker could predict treatment response and help prevent metastasis. Story

> Microlin Bio files for a $25M IPO to advance cancer Dx and Rx treatments. Story

> Dutch research hospital teams with Probiodrug to assess Alzheimer's biomarker assays. Story

> Dako joins with Merck to concoct cancer treatment companion Dx tests. Article

> Quest seals 3 new Dx development deals. Item

And Finally... How will Medicare identify "abusive" prescribers? Report

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