Spotlight On... Novimmune wins 'breakthrough' tag for rare disease drug; Novo gets an FDA date for diabetes combo; and more...

Swiss biotech Novimmune picked up the FDA's coveted breakthrough therapy designation for its treatment for rare immune disorder, promising the company preferred access to regulators as it works through Phase II development. The breakthrough tag applies to Novimmune's NI-0501, a potential therapy for hemophagocytic lymphohistiocytosis, or HLH, which is a rare disease that results in overproduction of infection-fighting cells and often proves fatal. The FDA's nod gives Novimmune a shot at early approval for its lead candidate. The company raised about $30 million in January to pay NI-0501's way through Phase II. More

@FierceBiotech: MIT team demonstrates potential of cancer combo for kinase inhibitors in mice. More from FierceBiotechResearch | Follow @FierceBiotech

@JohnCFierce: Biotech Lesson: Be overtly transparent. If you're hiding something bad, you're asking for it. , etc. | Follow @JohnCFierce

> Novo Nordisk ($NVO) is slated to appear before the FDA's independent committee of diabetes experts on May 25 to make the case for a fixed-dose combination of its blockbuster GLP-1 treatment Victoza and the recently approved insulin Tresiba. Item

> Tiny Microlin Bio is trading 6.7 million shares and $1 million in cash for Marina Biotech's pipeline of nucleic acid treatments, led by a Phase I therapy for the genetic disorder familial adenomatous polyposis. News

Medical Device News

@FierceMedDev: Dexcom integrates its latest CGM into the Apple Watch. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: FDA panelists to focus on use of Abbott's Absorb in small vessels during deliberations. More | Follow @VarunSaxena2

@EmilyWFierce: Good news, hep C drugmakers: VA stops rationing your pricey treatments. FiercePharmaMarketing story | Follow @EmilyWFierce

> AliveCor discloses EKG band for Apple Watch, upgrades existing a-fib app. Report

Pharma News

@FiercePharma: Activist Ackman vows to intervene after disastrous day at Valeant. Story | Follow @FiercePharma

@EricPFierce: ICYMI: Vertex, committed to continuous manufacturing, has Hovione build plant to complement the one it already has. Article | Follow @EricPFierce

@CarlyHFierce: I've wasted a solid part of my morning just staring at pg. 42 in disbelief. More | Follow @CarlyHFierce

> CDC guidelines call for drastic cuts in opioid painkiller use. Story

Pharma Marketing News

> GlaxoSmithKline's nicotine franchise pairs up with smoking cessation app. Report

> Good news, hep C drugmakers: VA stops rationing your pricey treatments. More

> Getting serious about digital: Takeda walks the walk with its digital accelerator model. Story

> Takeda dumps weight loss med Contrave, leaving Orexigen in the lurch. Article

Biotech Research News

> Novartis-allied scientist at Penn creates a new CAR-T model for solid tumors. More

> HDAC/PI3K inhibitors could treat common childhood cancer. Report

> MIT team demonstrates potential of cancer combo for kinase inhibitors in mice. Story

> New insights into Parkinson's disease. Item

> HIV drug increases therapeutic window for skin cancer by slowing drug resistance. Article

Vaccines News

> Journal walks back 'seriously flawed' study critical of Merck's Gardasil. More

> Analyst: Mitsubishi Tanabe's tobacco-based flu jab could have 'significant impact' on market. Story

> Health agencies inform on Zika vaccine timeline. Report

> Valneva scores $42M supply contract with DOD. News

> Duke, NIAID track HIV evolution with eyes on creating a vaccine. Article

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