FDA reduces device user fees; Transluminal gets CE mark for vascular closure device;

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> The FDA announced a slight decrease in fees it will charge medical device manufacturers in Fiscal Year 2015. More

> Transluminal Technologies received a CE mark for their Velox CD vascular closure device, a single-use device that is applied after percutaneous femoral procedures to shorten patient time-to-ambulation. Story

> Vascular Solutions and Boston Scientific ($BSX) have reached a settlement after a lawsuit in which both companies claimed patent infringement of guide extension catheter design. Release

Biotech News

@FierceBiotech: Nominations are open for our 2014 Women in Biotech report. More | Nomination form | Follow @FierceBiotech

@JohnCFierce: Love this stuff--Sanofi, Regeneron seize a regulatory shortcut in blockbuster PCSK9 race with Amgen. Story | Follow @JohnCFierce

@DamianFierce: Just wait until $GALT finds out what people on Friendster are saying. Story via Yahoo! Finance | Follow @DamianFierce

@EmilyMFierce: Merck aims to boost HPV vaccination rates amid lagging numbers. Story | Follow @EmilyMFierce

> Cold Genesys rakes in $13.6M for its cancer-fighting virus. News

> AstraZeneca dials up its immuno-oncology focus with blockbuster hopes. Article

> Gene therapy biotech Avalanche banks $102M in an up-sized IPO. Story

Pharma News

@FiercePharma: ICYMI: Novartis reports high Bexsero uptake as it pushes ahead in open market. FierceVaccines story | Follow @FiercePharma

@TracyStaton: On $PFE, the market's focus is on EPS beat. 58 cents vs. expected 57. Shares up 1.3% pre-market. Release | Follow @TracyStaton

@EricPFierce: Run-ins with the FDA continue to chew up the earnings at India's Ranbaxy. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: ICYMI: This week's full issue of FiercePharmaMarketing. Report | Follow @CarlyHFierce

> Eyeing consumer health, Meda nabs Italy's Rottapharm in long-sought $3B deal. Article

> Novartis apologizes for lax business practices in Japan as side-effects scandal widens. More

Vaccines News

> Kenya study reveals new malaria vaccine targets. More

> Flu season should return Sanofi to double-digit vaccines growth, CEO says. Item

> Novartis reports high Bexsero uptake as it pushes ahead in open market. Story

> Merck aims to boost HPV vaccination rates amid lagging numbers. Article

> Pfizer finally lands vaccines bulk-up with $635M Baxter buy. News

Pharma Manufacturing News

> Pfizer buys a portion of a vaccine plant from Baxter, J&J sells a vax facility to PaxVax. Item

> Hospira's Rocky Mount plant meets FDA goals, but one in India does not. Article

> Ranbaxy rings up another loss as regulatory problems chew away profits. Story

> Spectacular warehouse burglary left extensive collateral damage for Eli Lilly. Article

> Manufacturing takes it on the chin in Amgen cuts. More

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