EMA says 'no' again to Pfizer's Xeljanz, but 'yes' to Novartis, Gilead; BMS to boost marketing of Eliquis;

@FiercePharma: Still trending: Our special report on the Top 20 Orphan Drugs by 2018. Report | Follow @FiercePharma

@EricPFierce: CEO Bob Hugin keeps pushing drumaker to new heights. Report | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: GlaxoSmithKline replaces head of business in China amid bribery investigation. Article | Follow @CarlyHFierce

> The EMA has denied an appeal from Pfizer ($PFE) after recommending against approval of its rheumatoid arthritis drug Xeljanz. Story

> The EMA has given approval to Novartis' ($NVS) new lung drug, Ultibro, which analysts say could reach $1.7 billion in sales outside the U.S., as well as to the HIV drug Tybost from Gilead Sciences ($GILD). Story | Story

> The drug market in Iran is poised for growth for Western drugmakers. Report

> The FDA is putting restrictions on Johnson & Johnson's ($JNJ) antifungal medicine, Nizoral tablets, warning it can cause severe liver damage and adrenal gland problems and can also result in dangerous drug interactions. Story

> The FDA has accepted a second NDA from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) for their new Type 2 diabetes drug Forxiga. Story

> Alexion ($ALXN) intends to open a laboratory and office in Dublin and hire 50 people as part of its plan to create a global supply chain. Report

Medical Device News

@FierceMedDev: If you missed it earlier this week, check out the "Top 10 Med Tech Investments of Q2" special report on FierceMedDev: Feature | Follow @FierceMedDev

@MarkHFierce: A blood diagnostic to predict sepsis death may be within reach. More | Follow @MarkHFierce

@DamianFierce: Cepheid wins FDA nod for combo TB test. Article | Follow @DamianFierce

 @MichaelGFierce: Silk brain implant releases seizure-reducing epilepsy drugs. Story | Follow @MichaelGFierce

> MC10, Reebok launch brain-impact sensor. News

> Edwards' Sapien valve drives a heady second quarter. Report

> Brain implant made from silk stems epileptic seizures. Item

Biotech News

@FierceBiotech: From FierceCRO.com: Icon ticks up guidance as revenue leaps another 21%. Item | Follow @FierceBiotech

@RyanMFierce: Lots of CHMP news today, notable win for Novartis in COPD and loss for Pfizer in RA. More | Follow @RyanMFierce

@EmilyMFierce: Antibody effective at fighting norovirus in chimps. Story | Follow @EmilyMFierce

> Novartis COPD drug gets European backing. Article

> Forest Labs wins FDA approval for antidepressant Fetzima. News

> U.K. biotech PolyTherics scores $20.1M in funding for Antitope merger. More

> GlaxoSmithKline, Biogen Idec strike antibody deals with biotech startup Adimab. Article

> Vertex shares slide after FDA slaps partial hold on hepatitis C drug. Report

And Finally... Bristol-Myers Squibb will put more marketing dollars behind bloodthinner Eliquis--which so far has failed to live up to expectations--as well as behind its diabetes portfolio. Story

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