@FierceBiotech: Ambit joins biotech IPO queue, seeks $58M as AML drug nears PhIII. News | Follow @FierceBiotech
@JohnCFierce: Manhandled by FDA in 2011, now a "no" in Europe. Gentium shares wrecked by fresh round of regulatory woes for lead drug. More | Follow @JohnCFierce
> A new Reuters poll of analysts found that the vast majority believe that Novo Nordisk's ($NVO) long-acting insulin Tresiba will be approved, but not for several years. The average projection was for a 2016 approval, which will cost Novo a considerable amount of revenue that had been expected from the U.S. market. The FDA stunned many with its recent rejection of Tresiba, raising fears that the agency is ratcheting up already high safety standards. The FDA demanded more studies before it would approve the therapy. Story
> San Diego-based Ventrix says that it's now prepping for human studies of VentriGel, a hydrogel designed to repair hearts following a heart attack. The treatment has been positive in animal studies using pigs. Story
> Regenerative med company Cytomedix is raising $27.5 million in loans and equity investments. Release
@FierceMedDev: Report: Middle East, North Africa poised for major device and Dx growth. Item | Follow @FierceMedDev
@MarkHFierce: Interesting challenge to the supremacy of surgical robots for a key procedure. News | Follow @MarkHFierce
@DamianFierce: Allergan won FDA approval for its new breast implant, but the agency wants quite a bit of post-market data. Story | Follow @DamianFierce
> Boston Scientific reaches into Japan with spinal deal. Article
> Cheap blood test measures Hodgkin lymphoma chemo success. More
Pharma News
@FiercePharma: Warning to Roche execs: Don't drink too much at a conference. Your peers are watching (and may report you). More | Follow @FiercePharma
@EricPFierce: Yet another pharmaceutical supplier makes a move on India to get in on the growing market there. News | Follow @EricPFierce
@AlisonBFierce: Rising vaccine prices mean fewer children are immunized. But competition from small vaccine makers could lower costs. Story | Follow @AlisonBFierce
> China leaps ahead of U.S. with plans for track-and-trace system. Item
> German cost agency spurns Xalkori, Komboglyze. Story
Pharma Manufacturing News
> Drug shortages play role in growth at West Pharmaceutical. Story
> Mylan closes on oncology API plant as it rolls through India. Report
> China mandates track and trace while U.S. dithers. Article
> Dutch excipient player makes move on India. More
Vaccines News
> Rising vaccine prices mean fewer children immunized. News
> Indian court: Sanofi doesn't owe taxes on Shantha merger. Report
> Universal flu vaccine still 5 to 10 years away. Item
> HealthMap helps patients locate nearby vaccination sites. Article
> Australia begins vaccinating boys for HPV. Story
And Finally… Investigators at Rutgers have shed new light on chemo-brain, offering clues for the mental fog that can descend on patients. Release