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The Germany-based company registered the Injex30 with the help of its exclusive distributor Hangzhou Hema Medical Equipment. The approval process, which took more than 1.5 years, has required

In addition to the CRL, the multi-specialty health care company has already received draft labeling from the FDA and expects minimal revisions to the labeling. In the CRL,

Santaris’ proprietary Locked Nucleic Acid (LNA) drug platform will be used in the discovery and development of the novel medicines. The LNA Drug platform combines the company’s LNA

The efficacy of MM-121 in combination with paclitaxel compared to paclitaxel alone in the neoadjuvant setting of HER2-negative breast cancer will be assessed in the study. MM-121 is

As part of the expansion, the company is expecting to construct new facility for hormone development, clinical trial manufacturing and commercial manufacturing operations besides adding around 25 employees.

More than 500 patients with inoperable liver metastases from primary colorectal cancer were enrolled and the primary results are expected in 2014. Sirtex Medical president Mike Mangano said

The therapy agent with AAV9 viral vector will deliver multiple genes such as Factor H, neural growth factors and regulators of TDP-43 to treat neurodegenerative disease ALS. Neuralgene

The company offers a range of trial-related services including regulatory approvals, medical writing, feasibility assessments, monitoring, project management and warehousing. Cromos Pharma chief executive officer Dr. Vladimir Bogin

The warning was based on ongoing inspection that raised lack of sterility assurance concerns in the facilities related to both the companies. A voluntarily recall of all sterile