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  • AdvaMed casts a skeptical eye at FDA's new expedited approval idea

    AdvaMed is taking a wait-and-see approach on the FDA's just-released draft guidance that describes a new program known as Expedited Access PMA for groundbreaking medical devices that are intended to treat or diagnose life-threatening or irreversibly debilitating conditions.

Varian's profits slip as revenue ticks up slightly

Devicemaker Varian Medical Systems watched its net earnings fall nearly 18% in its fiscal second quarter, as a spike in R&D expenses wiped away slight gains in revenue.

Zimmer, Biomet to join forces in $13.4B deal

Zimmer and Biomet signed a deal to combine forces and form an orthopedics giant in the $45 billion musculoskeletal industry. The companies had combined revenues of $7.8 billion in 2013.

Breast cancer screening company Quantason files for Chapter 11

Los Angeles-based Quantason, which was working to develop an advanced ultrasound to screen for breast cancer, filed for Chapter 11 bankruptcy protection with an eye on finding a buyer.

BioFire buy boosts bioMérieux earnings

France's bioMérieux reported a rise in quarterly earnings of 3.3%, compared to the first three months of 2013, to $512.50 million.

Lombard Medical revives stateside IPO plans with a $55M debut

Lombard Medical revived plans to go public with a revised stateside IPO. The news comes less than two weeks after the company decided to postpone its public offering, citing poor market conditions.

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FiercePharma

After Tuesday's precedent-setting deal announcement, today's earnings release from Novartis had to be an anticlimax. And it was: Adjectives used to describe the results were unexciting words like "solid" and "flat" and "nice" and "largely in line."

FierceBiotech

Orphan drug outfit Hyperion Therapeutics has struck up a deal to acquire Israel's Andromeda Biotech, handing over as much as $570 million in cash and stock with eyes on a Phase III diabetes treatment.