Spotlight On... Incyte shares slip as PhII flop signals new problems ahead; Manchin says he'd filibuster Califf's nomination to head FDA; FDA approves Takeda's GERD drug; Human Longevity buys LifebankUSA; and more...

Incyte ($INCY) took a nasty hit on its share price today after it reported that a combo study of Jakafi (ruxolitinib) and regorafinib (Bayer's Stivarga) failed a Phase II study on colorectal cancer. An interim analysis of the data concluded that the trial was a flop and analysts concluded that the risk of failure for pancreatic cancer, as well solid tumors in general, has gone up considerably. Incyte's shares dropped about 10% on the news. Not all analysts are so bearish, but in today's bear market for biotech stocks bad news is heavily amplified. Release

@FierceBiotech: UT Southwestern team IDs next-gen approach to fighting pancreatic cancer. FierceBiotechResearch article | Follow @FierceBiotech

@JohnCFierce: Turn out the lights, the party is over: Gov't finds Theranos lab poses 'immediate jeopardy to patient safety.' CNBC article | Follow @JohnCFierce

> Robert Califf is facing growing opposition to his nomination as the new head of the FDA. West Virginia Senator Joe Manchin said he would filibuster the nomination, joining a group of lawmakers who have attacked Califf for his past ties with the pharma industry. Story

> The FDA has approved Takeda's Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole used to treat GERD. Release

> The genomics company Human Longevity has struck a deal to acquire LifebankUSA, which is involved in placental and cord blood banking. Release

Medical Device News

@FierceMedDev: Israeli VC backed by Philips and Teva looking to invest $26M in promising med tech startups. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Sony, Carlyle Group, KKR among bidders for Toshiba's imaging unit, expected to fetch $3B+. Article | Follow @VarunSaxena2

@EmilyWFierce: Dog flu sweeps the U.S. with two more confirmed cases in Washington state. FierceAnimalHealth story | Follow @EmilyWFierce

> Investor urges J&J to spin out poor-performing device, consumer businesses. Report

> HeartWare succumbs to activist investors, calls off planned Valtech purchase. Story

> CMS draws blood, says Theranos poses 'immediate jeopardy to patient health.' Article

Pharma News

@FiercePharma: No obvious China baby bump for J&J as one-child policy ends. FiercePharmaAsia article | Follow @FiercePharma

@EricPFierce: Novartis is revamping its manufacturing after having disposed of 25 plants. FiercePharmaManufacturing article | Follow @EricPFierce

@CarlyHFierce: ICYMI: U.K. cost watchdog nixes pricey biologics for moderate rheumatoid arthritis. Article | Follow @CarlyHFierce

> Riding Q4 diabetes growth, Lilly aims for even more with Jardiance. Report

> State AG's protest against Gilead pricing destined to fail, legal observers suggest. Story

> Big investor pushes 'underperforming' J&J to step up or split up. Article

CRO News

> PRA recruits a U.K. marketing firm to help it reach more patients. Report

> In the midst of cuts, Parexel signs new research deal. More

> Parexel dims its revenue expectations despite a solid quarter. Story

> Icon launches new tech with promise to simplify adaptive trials. News

> BioClinica notches up another deal, this time with EPS. Article

Pharma Manufacturing News

> Lilly closing two animal health manufacturing plants picked up from Novatis. Article

> Baxter recalls saline, other products, contaminated by cardboard, cloth and skin. News

> Novartis revamping manufacturing after hiving off 25 plants. More

> GSK production coming up short for meningitis B vax, causing some shortages. Item

> Recipharm wrapping up its $105M deal for Indian sterile injectables maker Nitin. Article

Pharma Asia News

> India's Supreme Court allows Cipla move in Roche patent case. News

> Sino Biopharma's asset management deal drawing negative reviews. Report

> 3SBio buys a larger stake in CP Guojian Pharma for $150M. Story

> Novartis expects India's Sun to meet February U.S. generic Gleevec launch. More

> Another legal test for U.S. in case of Chinese scientists accused of stealing GSK secrets. Article

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