Gilead hep C combo continues to score high in PhIII; Foundation Medicine partners with MSK; Ambit sets IPO range

 @FierceBiotech: Flemming Ornskov -The 25 most influential people in biopharma today. Profile | Follow @FierceBiotech

 @JohnCFierce: New Shire CEO Ornskov shakes up company after seizing the rein. Article | Follow @JohnCFierce

 @RyanMFierce: Gilead is trading up about 5% on Ph2 news of 95%-plus SVR rates with sofosbuvir + ledipasvir w/ & w/o ribavirin. One patient relapsed. | Follow @RyanMFierce

> Gilead ($GILD) is wasting no time in pushing a closely watched in-house hepatitis C combo through a late-stage program. The biotech said this morning that it is launching a third Phase III for sofosbuvir and ledipasvir. And new interim data on the matchup demonstrates a high rate of success after just four weeks of treatment. "The LONESTAR results suggest that once-daily all-oral therapy with the nucleotide NS5B inhibitor sofosbuvir and the NS5A inhibitor ledipasvir may have the potential to cure most genotype 1 HCV infected patients with a remarkably short treatment duration," said Eric Lawitz, the principal investigator. Bristol-Myers Squibb ($BMY) has complained loudly that Gilead has refused to run a late-stage study of sofosbuvir with its own hep C drug, daclatasvir, which had demonstrated a 100% cure rate for groups that include the hardest-to-treat patients. But Gilead hasn't looked back. Release

> Foundation Medicine will collaborate with Memorial-Sloan Kettering on new diagnostics able to match patients with hematological cancers with the best therapies. Story

> Ambit Biosciences has set a range of $13 to $15 a share for its IPO, which is intended to raise $65 million. Report

Medical Device News

 @FierceMedDev: FDA slaps Class I on Covidien's ventilator battery recall. News | Follow @FierceMedDev

 @MarkHFierce: Smith & Nephew nailed down some M&A in India and launched a $300M share buyback. The goal: renewed growth. Article | Follow @MarkHFierce

 @DamianFierce: St. Jude is studying its next-gen CRT-D with an eye on FDA approval. More | Follow @DamianFierce

> Cardiovascular Systems' Q3 revenue grows. Story

> Study: Zinc may be ideal for bioabsorbable stents. More

> Australian team advances Alzheimer's blood test work. DxExtra

Pharma News

 @FiercePharma: Provigil generics drag Teva profits down; sales off 3.9%. Copaxone up 17%, but how long can that last w/ new MS competition? | Follow @FiercePharma

 @EricPFierce: Pharma cargo thefts spike as robbers hit pharmacy delivery van in "last-mile" attacks. Chances of violence higher. Article | Follow @EricPFierce

> Sanofi sales, profits fall short, but CEO sticks to growth promises. More

> Takeda persuades Actos judge to toss $6.5M jury verdict. News

Pharma Manufacturing News

> China sets rules for excipient makers after scandal. News

> Manufacturing issues trip up approval for Gilead, Impax. Article

> Cargo thefts spike as robbers target pharmacy deliveries. Report

> More recalls as Hospira struggles to right manufacturing. Story

Vaccines News

> H7N9 may have evolved from four origins. Item

> GSK, Sanofi vaccines proving effective in measles outbreak. Report

> U.K. vaccine expansion a boon for GSK and Merck. More

> Merck's Gardasil looks effective in two-shot regimen. Article

> Search goes on for HIV vaccine after NIH trial nixed. Story

And Finally… A new CenterWatch survey ranks INC Research as the top CRO in the industry. Release

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