FDA goes to work on Merck's app for new allergy treatment; Oncolytics shares jump;

 @FierceBiotech: From FierceBiotechResearch.com: New drug could combat resistant #malaria strains. Story | Follow @FierceBiotech

@JohnCFierce: 3 yrs after its first CRL, A.P. Pharma gets another. Insists it can do a quick turnaround, but wrong again on FDA: News | Follow @JohnCFierce

@RyanMFierce: With big RNA deal, AstraZeneca's Soriot signals yen for risky science. More | Follow @RyanMFierce

> The FDA has begun a review of Merck's ($MRK) new treatment for grass pollen allergy, which is designed to block symptoms over time rather than just temporarily stop the sneezing, as current treatments do. The company, which mounted a slate of studies to set up an approval for a mass market, says it expects to get a decision from regulators in the first quarter of 2014. Story

> Shares of Canada's Oncolytics Biotech ($ONCY) jumped on their claim that a mid-stage study of the lung cancer drug Reolysin proved positive. Story

Medical Device News

 @FierceMedDev: CMO adds 200 medical device jobs in Ireland. Report | Follow @FierceMedDev

 @MarkHFierce: A new FMD feature--this week in FDA med tech violations, the device industry's police blotter. More | Follow @MarkHFierce

 @DamianFierce: Abbott won the FDA's OK for a diagnostic that detects birth defects and testicular cancer progress. News | Follow @DamianFierce

> T2 reels in $40M Series E for Candida assay trial and launch. Article

> U.K.'s Consort Medical mulls Dx expansion. Report

> Bacterin 2012 revenue climbs but losses also grow. Item

Pharma News

@FiercePharma: Conquering the complexities of biologics to get to biosimilars. Special report | Follow @FiercePharma

@EricPFierce: Alexion files 8-K saying FDA is not impressed with its manufacturing at its Rhode Island plant. 8-K filing | Follow @EricPFierce

> Rose-colored glasses off for many of 2012's new drugs, report shows. More

> Drugstores push for access to secret PBM pricing-and-reimbursement info. Story

Vaccines News

> GSK vaccine plant helps U.S. arm for biodefense. Report

> Taboo topics: Sex, politics, religion... and vaccines? Article

> Swedish study adds to data linking GSK vax to narcolepsy. Item

> FDA moves decision day for GSK pandemic vaccine, but why? More

Pharma Manufacturing News

> Alexion gets warning letter for Soliris plant. Report

> FDA lifts ban on some Aurobindo antibiotics. News

> Injection point: BD, Teva, Hikma target sterile injectables. Story

> GSK gets OK for $91M vaccine plant with Texas A&M. Article

And Finally… Investigators at Northwestern Medicine say they have ID'd a component of the herpes virus that "hijacks" machinery inside human cells, allowing the virus to rapidly and successfully invade the nervous system upon initial exposure. Release

 

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