Spotlight On... FDA sets LixiLan decision date for Sanofi-Novo diabetes showdown; Eylea could outshine Bayer's sales forecasts, analyst predicts; Bayer scores EU nod for hemophilia A med Kovaltry; and more...

Sanofi's ($SNY) LixiLan combo candidate is now in the hands of the FDA with a decision deadline set for August. And that means it won't be long before the med--which pairs the French drugmaker's blockbuster basal insulin Lantus with new GLP-1 contender Lyxumia--takes on Novo Nordisk's ($NVO) Xultophy, a marriage between GLP-1 treatment Victoza and new insulin product Tresiba. More from FiercePharmaMarketing

Bayer has been reaping the benefits from hot launcher Eylea since the drug made its European debut in November 2012. But even with the eye med's success so far, Eylea's market potential may be a bit underestimated, one analyst believes. According to Bernstein's Ronny Gal, while the wet age-related macular degeneration market--Eylea's first--"appears to be saturating," there's plenty of room to grow in other indications. In particular, use of so-called VEG-F products such as Eylea in patients with diabetic macular edema is expanding, giving the treatment an opportunity to outshine Bayer's current sales forecasts. More from FiercePharmaMarketing

@FiercePharma: Global group says Zika highlights need for research collaborations across specialties. More from FierceAnimalHealth | Follow @FiercePharma

@EricPFierce: ICYMI from FiercePharmaManufacturing: New York gives $200M for Athenix to build Buffalo plant. Company pledges 900 jobs over 10 years. Report | Follow @EricPFierce

@CarlyHFierce: ICYMI Friday: Perrigo pushes forward with Ireland expansion as sales, earnings lag. Article | Follow @CarlyHFierce

> Bayer won European approval for its hemophilia A drug Kovaltry, the latest in a franchise headed up by Kogenate. Report

> German cost-effectiveness watchdogs said the additional benefits of Sanofi and Regeneron's ($REGN) cholesterol fighter Praluent are "unproven" as it kicks off pricing negotiations on the product. Release

> India's Lupin will sell off two generic drugs to clear antitrust hurdles to its $880 million buyout of Gavis Pharmaceuticals. Report

Medical Device News

@FierceMedDev: ICYMI Friday: FDA warns two diagnostics players for marketing unapproved tests. Article | Follow @FierceMedDev

@StacyALawrence: Philips unveils wearable, wireless vitals patch that goes from hospital to home. News | Follow @StacyALawrence

@VarunSaxena2: ICYMI from FierceDrugDelivery: Early-stage drug delivery implant targeting pancreatic cancer tumors showing promise. Story | Follow @VarunSaxena2

@EmilyWFierce: AstraZeneca bags EU approval for gout drug Zurampic as it eyes $500M in sales. More from FiercePharma | Follow @EmilyWFierce

> Boston Sci nabs first CE mark for drug-polymer combo stent for above-the-knee PAD. Story

Biotech News

@FierceBiotech: ICYMI Friday: Novartis' blood cancer drug bags a 'breakthrough' tag on the way to FDA filing. Article | Follow @FierceBiotech

@JohnCFierce: Chimerix scraps two PhIII trials as it regroups in wake of a setback. News | Follow @JohnCFierce

> Syndax readies its 2nd IPO attempt during a market tempest. News

> Amgen's osteoporosis drug 'romo' comes through with promising PhIII. Article

> Trevena snags a 'breakthrough' tag for its Phase III postoperative pain drug. More

Animal Health News

> Aratana shoots for first European approval with canine arthritis drug. Report

> Global group says Zika highlights need for research collaborations across specialties. More

> U.K. charity sets out to sequence genomes from 50 dog breeds this year. Story

> Study: Fat cats will still love you if you put them on a diet. Item

> Pawprint looks to make its mark with EMR-based mobile app for pet owners. Article

Biotech IT News

> IBM strikes $2.6B deal for Truven to feed Watson's appetite for health data. News

> Ransomware becomes big business as hackers demand $3M to relinquish control of hospital files. Report

> Silicon Valley's biotech scene looks to bounce back from Theranos' 'black eye.' Story

> FDA tallies up 35 security incidents a month as hackers pursue stock-moving details. More

> Gamers crush algorithms in RNA structure design challenge. Article

Pharma Marketing News

> With LixiLan decision date set, Sanofi nears another head-to-head contest with Novo. Report

> Mylan gets one step closer to finally challenging Glaxo's Advair. Item

> Bayer's Aleve and GSK's Flonase top list of OTC TV ad spenders for 2015. Story

> Devicemakers give pharma a run for their money with new DTC ads. More

> Eylea may be giving Regeneron trouble in the U.S., but it's pumping up for Bayer in EU. Article

And Finally... Merck & Co. ($MRK) and GlaxoSmithKline's ($GSK) vaccines against the human papillomavirus have sharply cut rates of HPV infection in teens, a study found. Report