AstraZeneca gets European OK for olaparib; Xencor soars after Novo inks $175M antibody discovery deal; Scioderm raises $20M for rare disease drug;

@FierceBiotech: From FierceDrugDelivery: RNAi specialist $ALNY to focus on three therapeutic areas. Article | Follow @FierceBiotech

@JohnCFierce: Merck beefs up its cancer drug pipeline in $375M OncoEthix buyout. News | Follow @JohnCFierce

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> AstraZeneca ($AZN) has won European approval of olaparib for ovarian cancer, a big milestone for a drug that has had a rocky history in the clinic. The drug failed a Phase III study for ovarian cancer, but AstraZeneca--which pegged peak sales of this drug at $2 billion--has been touting subpopulation data underscoring its efficacy among a group of patients with germline BRCA mutations. An FDA advisory group recently voted overwhelmingly against an accelerated approval in the U.S., leaving many analysts expecting the agency to force the pharma giant to wait for new Phase III data to make its case. The drug will be sold as Lynparza in Europe. It is the first PARP inhibitor to reach the market. Story

> Shares of Xencor ($XNCR) shot up 30% this morning after Monrovia, CA-based biotech spread the word that it had inked a discovery deal with the Danish powerhouse Novo Nordisk. The biotech will put its bispecific antibody tech to work to come up with new therapies for an undisclosed target of Novo's choosing. And Xencor will get up to $175 million for a package of milestones and an undisclosed upfront--which are typically modest when it comes to discovery-level pacts. And Xencor signaled its readiness to do more deals like this. "This collaboration marks the first time we have used our new XmAb bispecifics technology, which consists of stable and easily expressed heterodimeric Fc domains that allow us to build robust molecules in a variety of formats that preserve many beneficial features of antibodies. The combination of our bispecific Fc domains with our unique FcγRIIb targeting technology allows us to create novel molecular structures and to explore a range of functional properties during discovery," said Bassil Dahiyat, Xencor's president and chief executive officer. Release

> Durham, NC-based Scioderm raised $20 million in Series B cash, with the Redmile group leading the round. The money is being earmarked for SD-101, an experimental therapy for Epidermolysis Bullosa, a rare condition that makes skin fragile. Release

> The Medicines Company and SciClone Pharmaceuticals forged a strategic partnership for two cardiovascular products in China. Release

Medical Device News

@FierceMedDev: ICYMI yesterday: Covidien, Stryker tout stroke study that used their stents. Story | Follow @FierceMedDev

@EmilyWFierce: San Francisco startup is reinventing the chicken egg with $90M in tow. Wired story | Follow @EmilyWFierce

> FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring. News

> AliveCor aims for widespread consumer adoption with new tech, reduced price. Article

> Myriad Genetics stymied in BRCA breast cancer test patent battle. Report

Pharma News

@FiercePharma: Top-read special report in pharma Wednesday was our newest, The top 10 patent losses of 2015. Check it out. | Follow @FiercePharma

@EricPFierce: With a 2nd plant on the AstraZeneca chopping block, 430 jobs on two continents now at stake. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: This week in #Vaccines: $GSK shingles candidate hits PhIII mark; Baxter backs out of vaccines. More | Follow @CarlyHFierce

> AstraZeneca snags EU approval for first-in-class cancer fighter Lynparza. News

> Flush-with-cash Shire revisits deal for NPS Pharma. More

> GlaxoSmithKline's shingles shot scores in 16,000-patient study. Item

Vaccines News

> Baxter backs away from vaccines with Vero tech sale to Nanotherapeutics. Report

> Study: Universal dengue vaccine may be possible thanks to antibody discovery. More

> Finnish scientists ID link between GSK's swine flu vaccine and narcolepsy. Story

> GSK shingles candidate hits its mark in hefty Phase III study. Article

> China green-lights domestic Ebola shot for clinical trials. Item

Pharma Manufacturing News

> FDA finds issues with Hovione plant in Portugal. Article

> Onyx Pharmaceuticals facility evacuated but no problems found. Item

> Owners, employees of compounder NECC indicted over lethal meningitis outbreak. News

> Pozen gets a second CRL as its API supplier awaits FDA reinspection. Story

> AstraZeneca targets U.K. plant for closure. Repor

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