German cost watchdogs shoot down Novo's Tresiba; India's Cipla wins FDA OK for HIV drug-delivery system;

@FiercePharma: India's pharmacies launch pre-emptive protest to online drug sales. FiercePharmaAsia article | Follow @FiercePharma

@EricPFierce: India's Wockhardt believes FDA issues at 2 key plants can be resolved sometime next year. Story from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: It's Stanley Cup Finals day!! And I just slipped "power play" into a headline. | Follow @CarlyHFierce

> Germany's cost watchdogs have said Novo Nordisk's ($NVO) next-gen insulin product Tresiba offers no additional benefit over other diabetes meds. Report

> Cipla has won FDA approval for a new drug-delivery system that can be used in treating infants and children suffering from HIV. Report

> Poor compliance management, internal controls, secured data and quality systems and lack of skilled resources are major concerns for India's drugmakers, a new Deloitte survey shows. More

> Medications-by-mail company PillPack says it's raised $50 million in funding. Report

> Mylan ($MYL) has rolled out a knockoff of Teva's ($TEVA) Seasonique in the U.S. Release

> Mylan has launched a generic of Shire's ($SHPG) Intuniv in the U.S. Release

> Ipsen has initiated a share buyback program. Report

Medical Device News

@FierceMedDev: Merck teams up with NanoString to find genes that predict response to Keytruda. FierceDiagnostics article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Ishrak plays up four-point integration plan during Medtronic's earnings call. Story | Follow @VarunSaxena2

@EmilyWFierce: LabCorp strikes liquid biopsy deal with Sysmex for cancer drug development. FierceDiagnostics article | Follow @EmilyWFierce

> FDA clears first 'smart' spirometer, enabling continuous tracking of lung function via tablet. Story

> Former Stryker R&D exec spins off new company with novel bone adhesive. Report

> Aussie startup gets $11.5M to market FDA-cleared, wearable Parkinson's disease tracker. Article

Biotech News

@FierceBiotech: Takeda uprooting its U.S. vaccines operations, joining the R&D migration to Boston. Report | Follow @FierceBiotech

@JohnCFierce: Trending: With a crucial CAR-T trial looming for Cellectis, a confident André Choulika is laying it all on the line. More | Follow @JohnCFierce

@DamianFierce: $FOLD plans to market the Fabry drug migalastat as Galafold. Release | Follow @DamianFierce

> Soon-Shiong raises $75M for another oncology player in his murky empire. Report

> Lilly's latest lung cancer contender lines up for FDA scrutiny. Item

> Ardelyx buys its troubled sodium drug back from AstraZeneca with Phase III in sight. Article

Pharma Marketing News

> Eyeing Xofigo growth, Bayer launches 'speak up' campaign in prostate cancer. News

> Big Pharma grapples with idiosyncrasies of orphan drug marketing. Story

> Novo Nordisk spins cycling into diabetes awareness with pro racing team. Article

> GSK's Flonase zooms to top of allergy category after DTC push. Item

> High-profile Huntington's disease film scores on social media, but where was pharma? More

Biotech Research News

> NCI matchmaker study explores uses of targeted drugs. Item

> Circadian rhythm research spotlights a possible cancer drug target. Report

> Aging researchers at McMaster flag role of a key protein in muscle loss. More

> Regenerative med researchers advance work on recycling discarded kidneys. Article

> Northeastern team solves mystery of recurring Lyme disease, offers a solution. Story

Diagnostics News

> Roche's Ventana teams up with Halozyme for pancreatic cancer companion Dx. Story

> Invitae slashes prices for full menu of genetic tests. Item

> LabCorp strikes liquid biopsy deal with Sysmex for cancer drug development. Article

> Merck teams up with NanoString to find genes that predict response to Keytruda. Story

> France's Labco sells out to Cinven for $1.3B after abandoning IPO. Report

And Finally... The White House convened representatives of hospitals, food producers, professional medical societies and restaurant chains on Tuesday and extracted pledges to cut down the use of antibiotics, overuse of which is creating resistance. More (sub. req.)

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