FDA advisers give Baxter's HyQvia a second look; Orexigen delays CHMP response on weight drug;

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

> FDA advisers are meeting today to review Baxter's HyQvia, an experimental therapy for primary immunodeficiency diseases. Approved in Europe, the treatment was earlier rejected by the FDA. Story

> Facing a variety of requests related to its European filing for the weight drug NB32, Orexigen ($OREX) says it will delay its response to the Day 180 List of Outstanding Issues by a month, filing them in Septermber. Release

Medical Device News

@FierceMedDev: Editor's Corner from @HollmerMark: In Q2, diagnostics venture investment showed some signs of life. Article | Follow @FierceMedDev

@StacyALawrence: Edwards stock surges on strong sales, profits due to legal settlement. Article | Follow @StacyALawrence

@VarunSaxena2: Johnson & Johnson to call for voluntary return of morcellators. WSJ story | Follow @VarunSaxena2

@MichaelGFierce:  Scientists test a nanoparticle "alarm clock" to awaken immune systems put to sleep by cancer. Release | Follow @MichaelGFierce

@EmilyWFierce: Boston Scientific wins first vaginal mesh case to go to trial. Article | Follow @EmilyWFierce

> FDA advisory panel to consider PMA of TissuGlu surgical adhesive. Article

> Ablatherm ultrasound prostate cancer treatment rebuffed by FDA panel. More

> Fat freezer Zeltiq turns a surprise profit and climbs almost 30%. 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 FiercePharmaMarketingReport | 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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