PHARMACY

Boehringer Ingelheim Pharmaceuticals starts phase-3 trial of HCV drug

BY Alaric DeArment

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

BI Pharmaceuticals is conducting the "HCVerso" trial of an HCV drug that combines faldaprevir, the experimental compound BI 207127 and ribavirin. The company has established trial sites in more than 25 states.

"We are proud to announce that the first patients are now enrolled in our phase-3 HCVerso program, including at U.S. trial sites," BI Pharmaceuticals VP clinical development and medical affairs Peter Piliero said. "Patients infected with HCV may benefit most from an individualized treatment approach since a person’s genetics, type of virus and stage of liver disease vary from patient to patient."

Previous trials of the drug have found that patients have been essentially cured of the virus a few months after starting treatment with the drug.


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PHARMACY

FDA approves sterile blood-plasma product

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma’s Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

"For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma and provides a reduced risk of certain viral transmissions," FDA Center for Biologics Evaluation and Research director Karen Midthun said.


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Report finds ‘innovative and robust’ global drug pipeline

BY Alaric DeArment

WASHINGTON — More than 5,000 medicines are under development, of which 70% are potentially the first of their class, according to a new report.

The Pharmaceutical Research and Manufacturers of America announced Thursday the release of a report developed by the Analysis Group that called the drug pipeline "innovative and robust." The pipeline includes 158 drugs under development for ovarian cancer, 19 for sickle cell disease and 41 for small-cell numb cancer.

"Biopharmaceutical companies, working with other partners in the American research ecosystem, have made incredible progress in helping confront some of the most challenging and costly diseases facing patients around the world," PhRMA president and CEO John Castellani said. "With more than 5,000 medicines in development for patients suffering from a wide range of diseases, there is a palpable excitement around the biopharmaceutical pipeline and the future opportunities for new, cutting-edge medicines to improve patient care and bring value to the entire U.S. healthcare system."

The report also noted that personalized medicines accounted for an increasing proportion of the pipeline, with the number of potential new medicines for rare diseases averaging 140 per year in the last 10 years, compared with 64 per year in the previous decade.


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