FDA reviewers question new Xarelto use; Shire predicts EPS at top end of forecast; Forest asks FDA for pediatric extension on Namenda;

@FiercePharma: Valeant, Mylan, and Actavis eye Pfizer's brand-new generics unit for buyout: Reuters. Story | Follow @FiercePharma

@TracyStaton: Top story at FiercePharma Monday: Look for an M&A scramble as pharma cash chases higher prices. Story | Follow @TracyStaton

@EricPFierce: India's Aurobindo is looking for more sterile injectable capacity and Actavis has some in the EU for sale. Deal? Story from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: Chinese corruption probe expands as officials detain former Sinopharm exec. More | Follow @CarlyHFierce

> Johnson & Johnson ($JNJ) could face an uphill climb for a new indication for its bloodthinner Xarelto, with FDA reviewers skeptical of its benefits. Report

> Shire ($SHPG) expects 2013 earnings growth to bump up against the top end of its forecasts, aided by a strategy shift and cost cuts. Report

> Forest Laboratories ($FRX) asked the FDA to extend its market exclusivity on the Alzheimer's drug Namenda, under the agency's pediatric-study program. Release

> Vivus ($VVUS), which makes the new Qsymia weight-loss pill, will collaborate with health insurer Aetna on a weight-loss program comprising drugs and lifestyle interventions. Release

> Colombia's Biotoscana inked a deal to buy a Brazilian pharma group, United Medical, to broaden its product portfolio and extend its commercial reach in South America. Release

> Portland, OR-based Galena Biopharma ($GALE) and India's Dr. Reddy's have teamed up to develop Galena's gastric cancer treatment NeuVax for sale in India. Release

> Mississippi-based Pharma Pac, which specializes in cream and ointment formulas, laid off 75 employees, or almost half its workforce. Report

Medical Device News

@FierceMedDev: JPM 2014: GlySure CEO hits SF to advance the company's ICU glucose monitoring device.  | Follow @FierceMedDev

@MarkHFierce: Phillips is in trouble with the FDA, in part, for conducting a recall and not informing regulators about the details. Warning letter | Follow @MarkHFierce

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

@EmilyWFierce: Hate getting shots? You might be able to try this painless drug injector soon. Article | Follow @EmilyWFierce

@GalenMoore: Covidien puts Almeida's JPM '14 words into practice with a brace of deals in emerging markets. Report | Follow @GalenMoore

> St. Jude's CEO is still betting on renal denervation, despite Medtronic's setback. Story

> Carlyle Group reportedly nears deal to grab J&J's Ortho Clinical Diagnostics unit. Item

> Qiagen and Exosome pair up for a Dx development deal. News

Biotech News

@FierceBiotech: Jazz bets up to $397M on Aerial's narcolepsy drug. Story | Follow @FierceBiotech

@JohnCFierce: I predict that today we'll move from deal talk to bold CEO projections at JPMorgan 2014. It is a fun spectator sport. | Follow @JohnCFierce

@DamianFierce: For its next trick, Moderna splits in two with $20M cancer venture. News | Follow @DamianFierce

@EmilyMFierce: Investigators find a way to keep stem cells' options open until they're needed. More | Follow @EmilyMFierce

> Bristol-Myers looks to rival Gilead for the key to conquering the hep C market. More

> Allergan CEO preps multibillion-dollar deal spree to swell pipeline. News

> Regeneron, Bayer reach for the old Eylea magic with combo AMD deal. Article

> AstraZeneca's Soriot faces off against skeptics, preaches late-stage R&D revival. Coverage

Biotech Research News

> Embryonic-like stem cells created from frozen tissue of Alzheimer's patients. More

> Scientists capture key protein structures that could aid malaria vaccine design. News

> Low doses of cancer drug prevent Type 1 diabetes in mice. Story

> Investigators find a way to keep stem cells' options open until they're needed. Article

> Mimetas, Galapagos partner on organs-on-chip technology. Piece

> European industry-academic partnership seeks miRNA therapies for neurodegenerative diseases. Item

Pharma Manufacturing News

> 11 compounders tell the FDA to bring it on. Report

> Aurobindo is looking to buy API plants from Actavis. More

> China corruption probe takes a turn into domestic drug distribution business. News

> Ranbaxy manufacturing drama continues with FDA action on API plant. Story

> McKesson recalibrates its EU strategy after Celesio deal nosedives. Article

> Wockhardt hires a new compliance exec in the face of FDA bans. Item

And Finally... High-tech facial reconstructions aren't just for humans anymore; they're going to the dogs (and cats). Report (sub. req.)

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