Spotlight On... Shire scores a patent victory for Lialda, but Bass-spurred PTO review looms; GSK, Bayer nab Japanese approvals; Mylan rolls out copycat form of Valeant's Ultram; and more...

Shire ($SHPG) has scored a victory in its quest to protect its patent on ulcerative colitis med Lialda. Tuesday, it said the U.S. District Court for Southern Florida had upheld Lialda's IP shield, determining after a lengthy journey through the court system that a copy from Allergan's ($AGN) generics unit infringed on that patent. But while Shire may be breathing easier now, it's not completely out of the woods. Pharma patent challenger Kyle Bass, utilizing the U.S. Patent Trademark Office (PTO) inter partes review system, in October scored a review of Lialda's patent protection, meaning that the Patent Trial and Appeal Board could nix that IP within the year. Release | More

@FiercePharma: Could J&J get an image boost from new health-oriented research? Experts say yes. FiercePharmaMarketing story | Follow @FiercePharma

@EricPFierce: Construction begins on Novo Nordisk's first US, API plant and first outside of Denmark. Report from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Looking for a respiratory edge, Boehringer teams with Propeller to test 'smart inhaler' for adherence. Article | Follow @CarlyHFierce

> GlaxoSmithKline ($GSK) won Japanese approval for its new biologic respiratory drug Nucala, which targets a specific, severe form of asthma. Release

> Bayer's hemophilia A drug Kovaltry and prostate cancer therapy Xofigo both won approval from Japanese regulators. Release | Release

> Mylan ($MYL) launched its new generic version of Valeant Pharmaceuticals' chronic pain drug Ultram. Report

> Keryx Biopharmaceuticals ($KERX) said its drug to treat iron deficiency anemia in chronic kidney disease patient hit its primary goal in a new late-stage study. Report

Medical Device News

@FierceMedDev: Former Apple exec leading consumer-focused wellness blood testing startup Cor. Article | Follow @FierceMedDev

@EmilyWFierce: Veracyte brings in $45M to spur growth for molecular diagnostics business. Article | Follow @EmilyWFierce

> Rock West Medical scores $1.25M to advance ingestible endoscope. Article

> Affymetrix spurns bid by former execs in favor of $1.3B offer from Thermo Fisher. Report

Biotech News

@FierceBiotech: Sanofi hires research veteran to 'rejuvenate' its R&D division. Article | Follow @FierceBiotech

@JohnCFierce: This Merck/Harvard preclinical deal was my no.1 story last week. Which is cool. Report | Follow @JohnCFierce

> Baxalta, Medicxi back upstart's work on building a better T cell for immuno-oncology. News

> Alexza literally at end of days as its cash pile set to run out by May. Story

> Sanofi recruits AstraZeneca research veteran to 'rejuvenate' its R&D division. Report

Drug Delivery News

> On top of strong efficacy data, Alder migraine med shows potential for differentiated drug delivery. Item

> FDA encourages generic abuse-deterrent opioids in latest effort to tackle prescription drug abuse. Report

> Vygon opens Portuguese plant for manufacture of oncology devices that deliver chemotherapy. Story

> Capsugel eyeing IPO or sale for $5B+; Bayer, Danaher, Thermo Fisher and others interested. More

> Antibiotics get a boost from stabilizing frog foam delivery. Article

Pharma Manufacturing News

> FDA cites Lupin Indian plants for what drugmaker calls 'minor' issues. More

> PuraCap gets Puerto Rico plant with buyout of Blu Pharmaceuticals. Report

> Natco plant closed during floods written up by FDA. Story

> Novo starts construction on $1.8B plant in U.S. Article

> Boehringer Ingelheim snags second client for its China CMO operation. Item

Pharma Asia News

> Samsung Bioepis offers a glimpse at biosimilar manufacturing prowess. More

> Biocon wins key Japan approval for Lantus biosimilar. Story

> South Korean startup biotechs gain government, banking funding lift. Article

> Prosecutors heap more woe on OBI Pharma as 'insider trader' investigation deepens. Report

> India releases guidelines on biosimilar approval, manufacturing. Item

And Finally... Google's ambitious new life sciences business Verily has lost a series of top managers and engineers. Report

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