Mylan sues FDA over Celebrex copies; GSK scores EU marketing approval for COPD drug Incruse;

@FiercePharma: Why pay $100B for AstraZeneca? Let Pfizer's CEO count the reasons. Story | Follow @FiercePharma

@TracyStaton: Which Big Pharmas aren't making deal headlines (at least not yet)? Roche. Sanofi. J&J. Bristol-Myers. They're definitely outnumbered. | Follow @TracyStaton

@EricPFierce: Analyst says Bayer may sale plastics biz for $10B, use that to help fund deal for Merck OTC biz, or Zoetis. More | Follow @EricPFierce

@CarlyHFierce: ICYMI Friday... Experts: MERS vaccine is possible--but is it worth it? Article | Follow @CarlyHFierce

> Mylan ($MYL) has filed a lawsuit challenging the FDA's ruling on generic exclusivity for copies of Pfizer's ($PFE) Celebrex. Release

> GlaxoSmithKline ($GSK) has nabbed EU marketing approval for COPD treatment Incruse. Release

> The EU has recommended Bayer's Nexavar as a treatment for thyroid cancer. Release | Report

> A European Commission (EC) committee has endorsed new advice to reduce risks of impaired next-day driving after taking zolpidem-containing sleep aids like Ambien. Release

> Hypermarcas topped Brazil's pharmaceutical market last month and plans to expand its lead, execs said Monday. Report

> Wockhardt says a state regulator in India has lifted its drug ban on the company. More

Medical Device News

@FierceMedDev: Ariosa faces new patent pushback from rival Illumina. Story | Follow @FierceMedDev

@VarunSaxena2: RT from FierceMedicalDevices: Covidien quarterly sales up 3% to $2.6 billion. News | Follow @VarunSaxena2

@EmilyWFierce: New device from scientists @MESImedical could speed up the diagnosis for peripheral artery disease. More | Follow @EmilyWFierce

@MichaelGFierce: Imaging technique maps transdermal drug migration. Item | Follow @MichaelGFierce

> Orbimed, Novo back SI-Bone in $33M round for ortho tech. Story

> LabCorp slips as Medicare bites into revenue. More

> Sorin snags FDA approval for mitral device. Item

Biotech News

@FierceBiotech: Forest lands Furiex and expands GI business in $1.5B buyout deal. Story | Follow @FierceBiotech

@JohnCFierce: Pfizer and AstraZeneca spent a combined $11.5B on R&D last year, with mixed results. You can imagine how much of that would be cut after a merger. | Follow @JohnCFierce

@DamianFierce: Biotech is finally invited to the deal parade: Forest buying Furiex for $1.1B plus an eluxadoline-tied CVR. Release | Follow @DamianFierce

@EmilyMFierce: "We're at a very unique point in biology," says Johns Hopkins Medicine's Aravinda Chakrararti. Biology is complicated but not random. | Follow @EmilyMFierce

> Ignoring harsh lessons, Pfizer pursues $100B deal to buy struggling AstraZeneca. More

> OncoGenex, Teva flag a failed PhIII for prostate cancer drug. Article

CRO News

> Biogen and Quintiles ink a deep-seated deal to boost R&D efficiency. More

> Medidata's sales leap on spike in eClinical demand. Story

> Harlan picks a partner and expands in Southeast Asia. Article

> Catalent ticks up revenue as IPO pends. Report

> Big Pharma megadeals could spell trouble for CROs. News

> Bristol-Myers deepens CMO deal with Samsung. Item

Biotech IT News

> NIH lays out plan to work exome data into clinical research. More

> Wellcome Trust order helps Illumina blast past HiSeq X Ten sale forecasts. Story

> Y Combinator seeking software-enabled biotechs after raising funding limit. Article

> Feds fret over threat of healthcare data theft. News

> U.K. seeks help prioritizing $3.4B of Big Data projects. Report

> Google patents show plans for smart contact lenses. Item

And Finally... Companies are using the "Mighty Mice" drug discovery to make meds that could help rebuild muscle. More (sub. req.)