Baxalta submits immunodeficiency drug to FDA; Alnylam advances a metabolic treatment;

@FierceBiotech: Patrick Soon-Shiong plucks another cancer drug out of Amgen's pipeline. Story | Follow @FierceBiotech

@JohnCFierce: Lipstick on a pig: XenoPort plunges as investors sour fast on "positive" psoriasis data. Article | Follow @JohnCFierce

@DamianFierce: Reminder that $NVO is risking billions of dollars on Tresiba data that management ~hasn't actually seen~. More from Reuters | Follow @DamianFierce

> Baxalta ($BXLT) submitted an FDA application for a new immunoglobulin therapy designed to treat primary immunodeficiencies. News

> Alnylam ($ALNY) is moving forward with an early-stage treatment for a rare metabolic disorder after charting positive signs in a Phase I study. More

> Genfit is developing a diagnostic test for nonalcoholic steatohepatitis (NASH). Item

Medical Device News

@FierceMedDev: Study: close management of blood pressure reduces cardiac disease, deaths. Article | Follow @FierceMedDev

@VarunSaxena2: UPDATED: FDA begs manufacturers to participate in global single audit pilot, says next stage may not be voluntary. More | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: Advera Health Analytics: Merck statins linked to more muscle side effects than rest of class. Report | Follow @EmilyWFierce

> Olympus, Sony focus on JV with high-def endoscope launch. Report

> Med tech IPOs fall into place: Penumbra, Symetis, Novocure and Adesto. Story

> Philips, Salesforce develop diabetes app, system to marry consumer and medical data. Article

Pharma News

@FiercePharma: Regulatory challenges top of mind at inaugural ACI animal health forum. FierceAnimalHealth story | Follow @FiercePharma

@EricPFierce: ICYMI: Sun targets Ranbaxy plant in Ireland as it prepares to trim manufacturing network. More | Follow @EricPFierce

@CarlyHFierce: ICYMI: Boehringer's Ofev, chasing a Roche rival, wins backing from NICE. Story | Follow @CarlyHFierce

> Payer hardball cuts price growth, with biggest hits in diabetes, COPD and hep C. Report

> Lilly gets preliminary NICE thumbs-down for Cyramza in stomach cancer. Story

> AbbVie edges closer to Imbruvica deal payoff with another FDA filing. Article

Drug Delivery News

> Novo, MIT's Langer Lab announce research alliance aimed at creating novel drug delivery devices. More

> Gene delivery player to go public this week, aiming to raise $100M. Item

> U.S.-Irish collaboration picks up $4.4M in pursuit of pancreatic cancer nanomeds. Report

> New surface protein found on cancer cells offers specific drug targeting, could spare fertility. Story

> Study finds ultrasound contrast agents can improve delivery of chemotherapy drugs. Article

Pharma Manufacturing News

> Abbott run-in with Indian regulators illustrates India's shortcomings: Reuters. More

> Endo's Qualitest recalls blood pressure, gout drugs. News

> California law requires drug info in 6 languages. Item

> U.K.'s Abzena shells out $8.4M for San Diego-based CDMO. Story

> FDA bans India's Polydrug plant, following actions by EMA and Canada. Article

Pharma Asia News

> China plans public health push on cancer, wants to expand screening. Report

> Japan's Eisai to present papers on Lenvima clinical data at European Cancer Congress. More

> Takeda crosses Actos settlement threshold as 96% of plaintiffs seek resolution. Story

> China plans medical exchange league with Arab states. Item

> Indian generics bid to challenge Gilead's Sovaldi patent dropped. Article