FDA adds infection risk to TNF-alpha boxed warnings; Hospira still struggling to fix N.C. plant woes;

@FiercePharma: Once again ... RT @Loftus: Drugs Beat Stents Against Stroke Recurrence in Study, via @WSJ. Item | Follow @FiercePharma

> The FDA has updated the boxed warning for TNF-alpha inhibitors to include risk of infection with Legionella and Listeria bacteria. The agency received 100 reports of infections in patients using the drugs, which include Remicade, Enbrel, Humira, Cimzia and Simponi. News

> Hospira ($HSP) expects sales growth to lag as it continues to work on problems at its North Carolina plants, a project expected to cost $65 million over three years. The company is eyeing M&A to move into fast-growing emerging markets. Item

> A U.S. District Court invalidated the patent on Acorda Therapeutics' spasticity drug Zanaflex, paving the way for Apotex to gain approval for its generic version. Story

> French officials may mandate conflicts-of-interest disclosures for regulators who review drugs for approval. Article

> Johnson & Johnson ($JNJ) faces safety questions from an FDA advisory committee about its surgical mesh product, which is now the subject of some 500 patient lawsuits. News

> Pharmacy services firm Omnicare ($OCR) has taken its $15-per-share bid for PharMerica to shareholders. Report

Biotech News

  @FierceBiotech:  Aura BioSciences banks $4.5M from private backers. Report  | Follow @FierceBiotech

@JohnCFierce: In matchup with Humira, tofacitinib pill lines up on efficacy, nothing new on safety BloombergNews | Follow @JohnCFierce

@RyanMFierce:  Sounds like bad news for Seattle-area biotech. Dendreon $DNDN has a conf. call this afternoon to discuss restructuring. Report | Follow @RyanMFierce

> BARDA continues support of pre- and post-exposure Anthrax vax. Report 

> Protalix showcases PhIII data for rare-disease drug in Pfizer pact. Article

> Aura BioSciences banks $4.5M from private backers. News 

> Pfizer lays out its pivotal case for oral RA pill against blockbuster Humira. Item 

> Dendreon banks on restructuring after stock craters. Story

Vaccines News

> Cuba announces launch of world's first lung cancer vax. News 

> Dendreon cancels GSK Provenge contract. Article

> Related bacterium could create viable TB vax. Story

> Merck finishes animal vaccine plant overhaul. News

> HIV envelope protein approach elicits vaccine immune response. Item

Manufacturing News

>  Price overlap blurs quality between generic, substandard drugs. Story

> Pfizer pushes iPads toward factory floor. News

> Brioschi antacid on a comeback, bringing manufacturing jobs to NY. Article

> Labor follows lead of Genzyme, others in green tie-up. Report

> Pharma's cold need is opportunity in all parts of supply chain. Story 

> Study finds quality risk gap between U.S., Puerto Rico plants. News

And Finally... A study found that patients implanted with Boston Scientific's stent for brain arteries experienced more strokes than those given standard medical treatment. Report

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