Gilead goes to Japan for Sovaldi OK; Regeneron's Eylea, Bayer's Stivargo get EU nods; Oil leaks into Teva growth hormone;

@FiercePharma: Top-read on FierceVaccines Thurs: CDC committee recommends AZ's FluMist over flu shot in children. Story | Follow @FiercePharma

@TracyStaton: Here's @JohnCFierce's take on the Vertex VX-809/Kalydeco PhIII, including interview with CEO Jeff Leiden. Story | Follow @TracyStaton

@EricPFierce: This Indian pharma exec understands how to attain quality production & that many of his compatriots do not. Article | Follow @EricPFierce

@CarlyHFierce: ICYMI: Bring out the confetti: 7 of 2013's launches will join Sovaldi, Tecfidera in blockbuster land. More | Follow @CarlyHFierce

> Gilead Sciences ($GILD) has submitted an application in Japan for approval of its wildly successful oral hepatitis C drug Sovaldi. Release

> India's Dr. Reddy's Laboratories has launched in the U.S. its generic version of Eli Lilly ($LLY) blockbuster antidepressant Cymbalta. Report

> Novartis ($NVS) is recalling 109,155 Foradil Aerolizer containing capsules of formoterol fumarate inhalation powder for treating asthma that it makes for Merck ($MRK), because they were out of specification for particle size. Report

> The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Regeneron Pharmaceuticals' ($REGN) Eylea for the treatment of sight problems related to diabetic macular edema (DME). Release

> CHMP has recommended Bayer Healthcare's cancer treatment Stivarga for the treatment of gastrointestinal stromal tumors. Story

Medical Device News

@FierceMedDev: Pharma company Merz to buy ultrasound company to strengthen beautification biz. Story | Follow @FierceMedDev

@StacyALawrence: Philips, to create clinical, cloud-based platform. Story | Follow @StacyALawrence

@MichaelGFierce: Intersect ENT files for $80M IPO to support steroid-delivering sinus implants. More via FierceDrugDelivery | Follow @MichaelGFierce

@EmilyWFierce: Hard verdict to swallow: New York high court shoots down NYC ban on super-sized sodas. More | Follow @EmilyWFierce

> FDA clears first robotic exoskeleton for patients with spinal cord injuries. Story

> Vagus nerve stimulator effective to prevent migraines, study says. Report

> Pharma company Merz to buy ultrasound company to strengthen beautification biz. Article

Biotech News

@FierceBiotech: This week's Chutes & Ladders: Former Avila CEO Bosley signs on to lead MA's Editas. Report | Follow @FierceBiotech

@JohnCFierce: Seriously, who in their right mind would buy Eli Lilly? They don't need protection. Story | Follow @JohnCFierce

@DamianFierce: I went to BIO 2014 and talked to people about the state of partnering. Article | Follow @DamianFierce

@EmilyMFierce: WHO calls 11-nation meeting over Ebola crisis in west Africa. More | Follow @EmilyMFierce

> Shire chief hits the road, talking up an AbbVie-free future. News

> Lilly and Boehringer inch closer to challenging Lantus with EU nod. More

> Retrophin slips on liver woes in rare disease drug's first trial. Article

And Finally... The FDA says Teva Pharmaceutical Industries ($TEVA) is recalling 129,000 cartons of somatropin growth hormone which could be contaminated with silicone oil that leaked from a line during freeze drying. Report