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Sandoz reports on six biosimilar molecules in the Phase III clinical trial/filing prep phase

BY Michael Johnsen

BASEL, Switzerland — Sandoz recently announced that the generic manufacturer continues to advance its biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase. 

For example, Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen’s Enbrel). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. 

Sandoz also completed a Phase III trial for the U.S. registration of biosimilar filgrastim (Amgen’s Neupogen) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen’s Neulasta). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen and Neulasta in breast cancer patients eligible for myelosuppresive chemotherapy treatment. Sandoz is currently preparing to file Filgrastim in the United States, and pegfilgrastim in the United States and Europe.

Sandoz also continues to make strong progress on its other biosimilar clinical development programs, which includes biosimilar versions of rituximab (Roche’s Rituxan/MabThera) and adalimumab (AbbVie’s Humira).

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Government report provides the science behind extended allergy season

BY Michael Johnsen

WASHINGTON — The Obama Administration on Tuesday unveiled the Third U.S. National Climate Assessment, a scientific report about climate changes that are happening now in the United States and how they are impacting the nation’s health, with longer allergy seasons, for example.

"Climate change, as well as increased CO2 by itself, can contribute to increased production of plant-based allergens," the report noted. "Higher pollen concentrations and longer pollen seasons increase allergic sensitizations and asthma episodes, and diminish productive work and school days. Simultaneous exposure to toxic air pollutants can worsen allergic responses. Extreme rainfall and rising temperatures also can foster indoor air quality problems, including the growth of indoor fungi and molds, with increases in respiratory and asthma-related conditions."

Ragweed pollen season length has increased in central North America between 1995 and 2011 by as much as 11 to 27 days in parts of the United States and Canada in response to rising temperatures, the report suggested. Increases in the length of this allergenic pollen season are correlated with increases in the number of days before the first frost. The largest increases have been observed in northern cities. In 2012, a warm winter leading to early pollen production among trees and plants, followed by hot, dry, low-humidity conditions through the spring and summer contributed to wide circulation of aeroallergens and a severe allergy season, according to reports from physicians. 

 

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Sun Pharmaceuticals to close facility in Detroit

BY Ryan Chavis

MUMBAI, India — Sun Pharmaceutical Industries last week announced that it notified the Workforce Development Agency for the State of Michigan regarding its decision to stop manufacturing operations and close the Detroit facility, which is located at Elijah McCoy, Detroit, Mich.

The company provided advance written notice of the closure to the employee union and all affected employees. Additionally, it has ensured that the affected employees will be compensated with more than the regular entitlement under the severance package. Employees also will receive other support services.

The company plans to ensure business continuity and avoid market shortage by transferring the manufacturing of products at this location to other units.

 

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