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The companies have decided to pull the application as no Japanese patients were included in two longer 52-week exacerbation studies of FF/VI and the six-month clinical data on

The approval also includes a companion test to identify appropriate patients. Gilotrif is indicated for NSCLC patients whose tumors express specific types of epidermal growth factor receptor (EGFR)

Simplifying testing and increasing performance of the process, the new capsules remove the need for costly, incompetent pooling of multiple batches for primary separations/prefiltration, secondary clarification, cell culture

Features of the new platform include automation-layer integration, equipment modeling and non-order work-flow management, which boosts manufacturing execution system (MES) impact and enhance time-to-results. Besides, it also assists

The US regulator approved the company’s abbreviated new drug applications (ANDA) for Repaglinide tablets, 1mg and 2mg, which are therapeutic equivalents of Novo Nordisk’s Prandin tablets. Indicated as

Following the approval by the USFDA of Dr. Reddy’s ANDA for Decitabine for Injection 50mg is available as a single dose vial. Decitabine that belongs to a class

The open label, parallel group study had randomized 132 type 1 diabetes patients with either BIOD-123 or Humalog to use as their mealtime insulin during a treatment period

During a preliminary interrogation, the suspected executives from GSK along with unspecified travel agencies admitted using fake receipts in tax crimes. The ministry has charged that GSK’s staff

Pulmonologists, who are the respiratory specialists treating the rare autoimmune disorder, will be targeted in the pilot effort. Questcor chief operating officer Steve Cartt, "We will hire a