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news.Meda’s NDA for new formulation of allergy drug accepted by FDA
Anders Lonner, CEO of Meda, said: “This product has the potential to become the first once-a-day nasal antihistamine in the US. Beside better tolerance with the new formulation
Anders Lonner, CEO of Meda, said: “This product has the potential to become the first once-a-day nasal antihistamine in the US. Beside better tolerance with the new formulation
According to the company, the initial personalized medicine services facilitate improved diagnostic, prognostic and therapeutic decision making for rheumatologists treating patients with rheumatoid arthritis (RA). Avise PG is
The Phase II study compared safety and efficacy of oral and intravenous forms of PTK 0796 to Zyvox in the treatment of patients with complicated skin and skin
The trial, conducted in accordance with FDA requirements, was a controlled, randomized, double-blind, partial cross-over study that compared Kamada’s intravenous alpha-1 antitrypsin (AAT) with a comparator product. Approximately
The Phase III study of almost 4,000 people 65 years of age and older compared the high-dose influenza vaccine with the standard inactivated influenza vaccine formulated for the
When choosing a high-energy device, physicians often must make trade-offs among device size, battery longevity and features. According to the company, the Cognis cardiac resynchronization therapy defibrillator and
The multicenter, double-blind, randomized, placebo-controlled Phase I study was designed to assess the safety and immunogenicity – a patient’s ability to generate an immune response – of four
This Phase II randomized study enrolled 253 patients with postsurgical pain. Three doses of ARRY-797 (200mg, 400mg and 600mg) were compared to placebo and celecoxib (400mg). In the
Results from the 50-patient placebo-controlled trial demonstrated that three of the four doses of INCB18424 evaluated (15mg BID, 25mg BID and 50mg QD) produced impressive clinical benefits and
AI-525 is a preclinical-stage injectable formulation of celecoxib using Acusphere’s proprietary Hydrophobic Drug Delivery System technology. The transaction is expected to close in approximately 10 days. The $15