Spotlight On... Shire's Ornskov signals a pause in dealmaking after a $50B buyout streak; On a roll, Novartis files Neulasta biosimilar in Europe; and more...

Shire CEO Flemming Ornskov

Shire ($SHPG), awaiting the close of its $32 billion merger with Baxalta ($BXLT), is planning to move away from its penchant for acquisitions and focus on developing and launching products, CEO Flemming Ornskov said. Speaking to the Financial Times, Ornskov said the Irish drugmaker has "more than enough to do right now" after spending billions on NPS Pharma and Dyax over the past year. Shire has said the Baxalta acquisition will help it grow revenue to $20 billion by 2020, and the company's biggest priority moving forward "is to get internal growth drivers to succeed," Ornskov said. Story

@FierceBiotech: ICYMI: Just how well do you think biopharma is handling the gender diversity issue? - interesting comments coming in. Article | Follow @FierceBiotech

@JohnCFierce: Two more IPOs out. It's like the Great Escape: AveXis and Proteostasis survive the market storm, raise $145M for R&D. Story | Follow @JohnCFierce

@DamianFierce: No better illustration of the monstrousness of capitalism than the fact that we're all at work on a Kanye album release day. | Follow @DamianFierce

> Novartis has filed for an EU application for its knockoff of Amgen's Neulasta, which earned about $4.7 billion last year. This is the pharma giant's 5th biosimilar application in Europe, marking the promised halfway point for its plans to rack up 10 approvals in the fast-growing field. Story

> Iowa's KemPharm (KMPH) says its NDA for the pain drug KP201/APAP has been accepted and granted priority review. Release

Medical Device News

@FierceMedDev: ICYMI yesterday: Israeli upstart raises $15M for U.S. pivotal trial of bioresorbable cartilage implant. Article | Follow @FierceMedDev

@EmilyWFierce: In this week's Dx Digest, $ILMN strikes a new sequencing deal and the Obama admin. calls for more Zika testing. More | Follow @EmilyWFierce

> Health system UPMC leads $17M financing for mental health wellness services app. Story

> Walgreens threatens to cancel its alliance with Theranos. Article

Pharma News

@FiercePharma: Phibro disappoints as quarterly results reflect shift away from antibiotics. FierceAnimalHealth story | Follow @FiercePharma

@EricPFierce: FDA warning letter says data falsification rampant at IPCA. Some senior managers involved. FiercePharmaManufacturing article | Follow @EricPFierce

@CarlyHFierce: Novartis bolsters its home-turf advantage in psoriasis with Cosentyx DTC push. FiercePharmaMarketing story | Follow @CarlyHFierce

> Big Pharma shells out big campaign dollars to presidential candidates. Report

> Mylan snags Meda, advances its OTC ambitions, with $7.2B deal. Article

CRO News

> Catalent posts flat revenue as currency woes bite into growth. Article

> Genomics England picks Icon as its first CRO partner. Report

> Quintiles bets on a big 2016 as revenue rolls in. More

> Recipharm commits $45M to counteract fake drugs. Story

> CRO Pharmaron acquires U.K.-based Quotient Bioresearch. Article

Pharma Manufacturing News

> Recipharm puts up $45M to enhance track-and-trace capabilities. Report

> Regulator suspends Spanish drugmaker over 'critical quality defects.' News

> Qualicaps gets Latin American foothold with acquisition of Brazil's Genix. More

> Regulator suspends Spanish drugmaker over 'critical quality defects.' Story

> Catalent France plant that was victim of sabotage getting back online. Article

Pharma Asia News

> FDA maintains tight grip on Indian and Chinese products. Report

> China drug safety improving, CFDA says. Item

> Sanofi banks on Philippines to lead public Dengvaxia rollout. More

> Japan's Sumitomo Dainippon ready for U.S. acquisitions. Story

> Chugai Alecensa PhIII trial halted early as patients show significant improvement. Article

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