FDA extends deadline on Afrezza decision; Gilead gets quick FDA review for hep C combo;

@FierceBiotech: Little Deciphera raises its cancer R&D flag in Boston's bustling biotech hub. More | Follow @FierceBiotech

@JohnCFierce: Agios shares spike on enthusiastic response to small, early-stage leukemia study. Story | Follow @JohnCFierce

@DamianFierce: Here's FierceBiotech's look at every drug developer IPO from the first quarter. Report | Follow @DamianFierce

@EmilyMFierce: 40% of the world's population is at risk from dengue. More in WHO's report for World Health Day. Report | Follow @EmilyMFierce

> The FDA has extended MannKind's ($MNKD) PDUFA date for the inhaled insulin Afrezza, which just won the backing of a large majority of agency advisors. The new decision date is July 15. MannKind's shares dropped 15% on the news. Release

> Gilead ($GILD) is getting a priority review from the FDA for its high-profile combination hep C therapy. A marketing decision on the combination of Sovaldi and ledipasvir should arrive by October 10, probably paving the way for the first big matchup to tackle an array of genotypes without the need to use interferon. Story

> Mersana Therapeutics has struck a collaboration deal with Takeda's Millennium unit to develop antibody-drug conjugates. Financial details were not disclosed. Release

Medical Device News

@FierceMedDev: CyVek immunoassay technology gets $10M investment. Story | Follow @FierceMedDev

@VarunSaxena2: ICYMI: After a successful IPO, LDR looks to raise more cash. News | Follow @VarunSaxena2

@MichaelGFierce: DNA nanorobot delivers drugs through flap that opens and closes. More from FierceDrugDelivery | Follow @MichaelGFierce

@EmilyWFierce: Motorized, sensor-driven wheelchair could provide a new level of mobility for those with severe disabilities. Article | Follow @EmilyWFierce

> Edwards Lifesciences wins CE mark for aortic valve system. More

> Roche snags diagnostics outfit IQuum in $450M deal. Story

> Medtronic buys out a distributor as it cozies up to Turkey. News

Pharma News

@FiercePharma: Top-read story this weekend: Novartis fighting two-pronged legal battle in India on Galvus patent. Story | Follow @FiercePharma

@TracyStaton: FiercePharma's best-read marketing story: Sanofi aims for outcomes with new Chief Patient Officer. Article | Follow @TracyStaton

@EricPFierce: Daiichi Sankyo hinted months ago it was tired of Ranbaxy's issues. Buyout means Sun Pharma takes them on. More | Follow @EricPFierce

@CarlyHFierce: Novartis meningitis B vaccine Bexsero receives FDA breakthrough therapy designation in the U.S. Release | Follow @CarlyHFierce

> GlaxoSmithKline confronts new bribery allegations, this time in Iraq. News

> Sanofi misled investors with rosy Lemtrada predictions, lawsuit alleges. More

> Mallinckrodt bets $5.6B on Questcor and its controversial Acthar drug. Story

CRO News

> Clinipace signs up to get a brain-stimulating device on the U.S. market. Article

> WuXi bets on anti-counterfeiting tech with an eye on drug safety. More

> Actavis picks Particle Sciences for generics development. Story

> AMRI expects its $41M Cedarburg deal to pay off right away. News

> Evotec lands two more deals to share risks and rewards of R&D. Report

> Charles River wraps up $179M deal for Galapagos' CRO biz. Item

Biotech IT News

> Merck KGaA and Pfizer tap into Broad Institute's data skills for lupus project. Story

> Tufts survey shows social media still on fringes of clinical trials. More

> Billionaire-backed startup puts Big Data, AI at the heart of drug discovery. News

> Merck vaccine plant taps R&D's Big Data platform to solve yield conundrum. Article

> IMS Health stock jumps after second biggest U.S. IPO of 2014. Item

> Europe to create public clinical trial results database after passing law. Report

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