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Big CROs are booming, but can it last?

The world's largest CROs are reaping the benefits of two major market trends: Big Pharma is finally getting back to spending big on R&D after some lean years post-downturn, and biotech is enjoying a protracted bit of bullishness that has lined pockets around the industry.

Charles River debuts new testing tech for quality control

Charles River Laboratories has unveiled a new technology it says can better test for impurities by combining two common methods into a single product, making for a flexible solution.

A glitch in bioequivalence software puts trial results in doubt

Observed glitches with Thermo Fisher's popular drug development software have led to concerns that data used to win approvals may have been faulty, and the company is working alongside regulators to figure out just how widespread the issue may be.

Roche taps DKSH to move its products in Asia

DKSH, a well-heeled pharma marketing operation, has reupped with Roche, expanding a long-standing agreement to include more of Asia.

PPD pairs off with Sellas to pick up the pipeline pace

PPD has signed a master service agreement with Swiss biotech Sellas, lending its drug development expertise to the company's efforts to advance a portfolio of treatments.

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FierceMedicalDevices

Cardiovascular device company Sorin Group has invested $20 million in Respicardia. The financing is to be used to fund ongoing clinical testing of the startup's remede System, which is a pacemaker-like device for central sleep apnea that delivers electrical pulses via an implantable lead to the phrenic nerve.

FiercePharma

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.