Novartis study finds Xolair combats hives; Merck to pay $8.5M for PA marketing allegations;

@FiercePharma: Reckitt Benckiser's heroin addiction drug Suboxone gets 2 generic rivals, despite co's attempt to block them. More | Follow @FiercePharma

@EricPFierce: Qualicaps, which Mitsubishi is buying, is investing $26 million to expand a plant in North Carolina. Article | Follow @EricPFierce

@AlisonBFierce: The FDA rejected Dynavax's Heplisav, an adult hepatitis B vaccine, causing shares to slide as much as 38 percent. News | Follow @AlisonBFierce

> Novartis ($NVS) said omalizumab controlled itching and hives in two-thirds of patients in a new trial, compared with 19% of placebo patients; co-developed with Roche ($RHHBY), the drug is marketed under the brand name Xolair to treat asthma. Release

> Merck ($MRK) will pay the Commonwealth of Pennsylvania $8.5 million to settle allegations that it improperly marketed the now-withdrawn painkiller Vioxx. Report

> Europe's Committee for Medicinal Products for Human Use recommended extending use of GlaxoSmithKline's ($GSK) human papillomavirus vaccine Cervarix to prevent precancerous lesions. Report

> AbbVie ($ABBV) hired Publicis Groupe's Spark agency to handle its $365 million advertising business, including online and offline media buying and planning. Report

> India's pharma industry is lobbying the government to exempt all pharma products from customs duties when imported into the country. Report

Medical Device News

 @FierceMedDev: Intersect ENT pulls in $30M Series D for sinusitis-implant sales push. More | Follow @FierceMedDev

 @MarkHFierce: Another successful post-marketing test will help fuel adoption of CardioDx's coronary artery disease Dx. News | Follow @MarkHFierce

 @DamianFierce: Despite the uptick in scrutiny, Indian clinical trial deaths were about the same in 2012 as in 2011. Story | Follow @DamianFierce

> Philips spinout grabs $9.9M for Parkinson's DBS trial. Article

> Biotronik nabs FDA nod for single-lead ICD. Report

Biotech News

 @FierceBiotech: In case you missed it last week: Fierce's Top 10 Biotech Techies - 2013. Special Report | Follow @FierceBiotech

@JohnCFierce: Royalty offer of $6.5B for Elan is smart. Investors can choose cash or Kelly Martin? No brainer. Just sweeten and stir. News | Follow @JohnCFierce

@RyanMFierce: Genentech opens mobile app playbook for tablet fans. Story | Follow @RyanMFierce

> Merck KGaA reports another R&D setback with PhIII brain cancer failure. News

> Dynavax regroups after FDA turns thumbs down on hep B vaccine Heplisav. Story

CRO News

> Chinese CRO ShangPharma one step closer to going private. Item

> Moody's says Quintiles is worth $4B, but IPO price remains mystery. Story

> Lonza inks $6.9M stem cell supply deal with NIH. News

> After Warnex buy, Biotrial jumps into bioanalytics. More

> Indian clinical trial deaths unchanged from 2011. Report

Biotech IT News

> Genentech opens mobile app playbook for tablet fans. News

> Medidata grabs software deal with Purdue Pharma. Article

> Ex-Merck dreamer Friend sharpens open science nonprofit with 'competition' edge. Story

> Boost in sales, customers pumps up Medidata's 2012 revenue. More

And Finally... Too many Americans still drink too much, according to a new study. Report

Suggested Articles

The triple combo era in cystic fibrosis is here thanks to Vertex' new OK. Five months ahead of schedule, the FDA green-lighted Trikafta Monday.

On the heels of settling bellwether cases for $45 million, Teva is offering $250 million cash and $23 billion in drugs to end all its opioid lawsuits.

Under assault in the anti-inflammatory market, J&J has focused on expanding Stelara beyond dermatology—and it just took a big step in that direction.