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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In our EuroBiotech roundup this week, NEC and Vaximm ink cancer vaccine pact, Compugen posts cancer data and Lunac raises cash.

Biotech venture fund ATAI Life Sciences has partnered with artificial intelligence drug discovery specialist Cyclica to form a new JV.