FDA fast-tracks Shire's Vyvanse for binge eating; Merck starts shipping Keytruda;

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@FiercePharma: Tops in FP this weekend: Analysts: Pfizer execs say they're locked-and-loaded on tax inversion, and open to targets. Article | Follow @FiercePharma

@EricPFierce: Apotex, which has had plenty of cGMP issues of its own, is recalling generic Paxil made at GSK plant. ICYMI from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI: This week's issue of FierceVaccines. To get it every week, subscribe here. | Follow @CarlyHFierce


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

> Shire's ($SHPG) ADHD drug Vyvanse scored a priority review at the FDA for a potential new use to treat binge eating disorder. Report

> Merck ($MRK) has already started shipping its brand-new cancer immunotherapy Keytruda, approved last week to treat melanoma. Report

> Patient groups put Germany at the top of the list of countries with the best access to medicines, with the U.S. tied for 7th place. Report

> A potential antidote to quickly reverse the blood-thinning effects of Boehringer Ingelheim's Pradaxa is moving into a clinical trial, to be conducted in emergency rooms in 35 countries. Report

Medical Device News

@FierceMedDev: ICYMI: ReWalk squeaks by with $36M IPO as oncology device player Mevion files to raise up to $69M. Article | Follow @FierceMedDev

@MichaelGFierce: HIV-fighting intravaginal ring research nets $20M from NIH. FierceDrugDelivery story | Follow @MichaelGFierce

> Medtronic launches wearable cardiac monitor acquired from Corventis. Article

> iPod touch to be used for diabetes monitoring following launch of HealthKit. Story

> Medtronic unveils new study showing 2-year success of its TAVR device. More

Biotech News

@FierceBiotech: Arch, Polaris back a $20M round for Scholar Rock's immune system R&D platform. Article | Follow @FierceBiotech

@JohnCFierce: This $AVNR "drug" is what gives biotech a bad name--simply awful. | Follow @JohnCFierce

@DamianFierce: ICYMI: $BIIB and $ABBV plan to market the monthly MS shot daclizumab as Zinbryta, filing in 2015. Release | Follow @DamianFierce

@EmilyMFierce: Well, this is an interesting development. Nature reviewers not persuaded by initial STAP stem cell papers. More from Science | Follow @EmilyMFierce

> Avanir skyrockets as its controversial generic combo claims a hit in PhII Alzheimer's study. Report

> Cancer R&D stars pitch an $86M biotech IPO for Kolltan Pharma. Story

> Roche's Genentech triggers its PhIII program for blockbuster AMD contender. News

CRO News

> Evotec signs a Huntington's deal as diabetes project falls through. Report

> Quintiles homes in on small biotechs with new service offering. More

> Recruitment specialist Trialbee snags a deal with AstraZeneca. Item

> Icon and Medidata unite to give patients a louder voice in clinical trials. Article

> PRA swings for $375M in the next big CRO IPO. News

Biotech IT News

> Wearables project aims to provide new source of data for MS trials. Story

> Application of regulatory handbrake to 23andMe offers cautionary tale to Silicon Valley. Report

> NCI turns to Dell for pediatric cancer research project. More

> AstraZeneca taps Trialbee for online patient recruitment. Article

> Mayo Clinic to apply IBM's Watson to matching patients to trials. Story

Animal Health News

> FDA seeks input on conditional approvals for new animal health products. Report

> Merck launches new vaccine to fight PRRS in pig herds. More

> European Commission adds new proposals for use of veterinary meds and medicated feed. Story

> Alivira snaps up 60% stake in Turkey's Provet Veterinary Products. Article

> Dechra Pharmaceuticals reports gains in full-year profit. Report

And finally ... Indian officials plan to sit down with Big Pharma execs worried about the country's patent-fighting policies to hear their concerns. Report