J&J heads to the FDA with a Gilead-aided HIV combo drug; Tetraphase bags fast-track status for its antibiotic;

@FierceBiotech: Stallergenes beats Merck to market as the FDA OKs its allergy pill. More | Follow @FierceBiotech

@JohnCFierce: Analysts, experts are dazzled by the blockbuster potential of Novartis' LCZ696. News | Follow @JohnCFierce

@DamianFierce: MannKind jumps ~125% after positive panel vote, reaching a four-year high. Story | Follow @DamianFierce

@EmilyMFierce: Most popular at FierceBiotechResearch.com: Committee finds 'scientific misconduct' in blockbuster stem cell papers. Article | Follow @EmilyMFierce

> Johnson & Johnson ($JNJ) is seeking FDA approval for a fixed-dose combination of its HIV treatment darunavir and Gilead Sciences' ($GILD) investigational cobicistat. News

> Tetraphase Pharmaceuticals ($TTPH) secured the FDA's fast-track designation for both oral and intravenous formulations of its antibiotic eravacycline, designed to treat complicated urinary tract and intra-abdominal infections. More

> Alzheimer's drug developer EnVivo Pharmaceuticals has changed its name to Forum Pharmaceuticals. Item

Medical Device News

@FierceMedDev: Four months later 23andMe's clash with the FDA over regulation of OTC genetic tests remains unresolved. Story | Follow @FierceMedDev

@MarkHFierce: Check out the latest FierceDiagnostics, with news involving Pfizer, colon cancer tests and HIV Dx funding. Report | Follow @MarkHFierce

@MichaelGFierce: In drug delivery, it's the little things that count. Looking back on the year in nanotech drug delivery. Special report | Follow @MichaelGFierce

@EmilyWFierce: Researchers at Cornell delve into "cereal box psychology" with new study on supermarkets and spokes-characters. Article | Follow @EmilyWFierce

> Thoratec smacked with FDA Class I recall concerning heart pump backup controllers. More

> Boston Scientific touts promising trial data for its transcatheter valve. Story

> Cepheid's 60-minute HPV test is now available in Europe. Item

Pharma News

@FiercePharma: Industry predicts dire consequences from FDA's generic labeling proposal. News | Follow @FiercePharma

@TracyStaton: GSK ditches ovarian cancer plans for Votrient after failed study. More | Follow @TracyStaton

@EricPFierce: GSK attacks African market with combo of goodwill, R&D and plant projects. Article | Follow @EricPFierce

@CarlyHFierce: Biogen's Alprolix nod is just the first tremor in a hemophilia market shake-up- FiercePharmaMarketing. Story | Follow @CarlyHFierce

> Amarin triples size of Vascepa sales force with Kowa promo deal. More

> ViiV adds pricey new HIV drug Tivicay to patent pool. News

> Can Auxilium's ED hopeful Stendra score with provocative March Madness ads? Item

Drug Delivery News

> Enzyme micropumps deliver insulin in response to glucose levels. Story

> Hydrogel delivers inhibitors directly to reduce damage after a heart attack. Article

> Harvard researchers create method to measure nano exposure for safety, delivery. News

> Water excited by infrared light melts nanoparticles to release drugs. Article

> DNA nanorobot delivers drugs through flap that opens and closes. Story

> Wearable data-storing 'electronic skin' could deliver drugs for epilepsy, Parkinson's. Brief

Diagnostics News

> Pfizer leads $21M Series B for a Michigan molecular Dx startup. News

> Exact Sciences' and Epigenomics' colon cancer tests clear FDA panel with mixed results. News

> New septic shock biomarker Dx could produce better care and smoother drug trials. Article

> U.K. team scores with blood test that might spot children likely to become obese. Story

> Zyomyx snags $7.5M from WHO's UNITAID to fund HIV/AIDS test in emerging markets. News

> Finding: 2 biomarkers for head and neck cancer can help predict radiation therapy resistance. Brief

Pharma Marketing News

> Sanofi aims for outcomes with brand-new Chief Patient Officer. Story

> Eli Lilly's sales force finds CRM harmony in the cloud. Article

> Biogen's Alprolix nod is just the first tremor in a hemophilia market shake-up. Story

> Can statin-maker Kowa help Amarin jump-start Vascepa sales? Article

> Auxilium aims Stendra's sexy March Madness ads at stiff ED competition. Story

> ViiV opens up brand-new HIV med Tivicay for cheap copies in poor countries. Brief

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