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FDA Clears Roche’s KRAS Mutation Test for Colorectal Cancer Patients

Today, Roche announced that US health regulators have approved its diagnostic test for a certain gene mutation in patients with advanced colorectal cancer. The company said that the US Food and Drug Administration (FDA) approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test …

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FDA Approves Bayer’s Avelox for Treatment of Plague

The US Food and Drug Administration (FDA) has cleared Bayer HealthCare Pharmaceuticals’ Avelox (moxifloxacin) for the treatment of pneumonic plague and septicemic plague. The drug is also approved for prevention of plague in adult patients. “Today’s approval provides an additional therapy for the treatment of plague,” said Edward Cox, MD, …

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FDA Staff Questions Benefit of Vertex’s Combo Cystic Fibrosis Drug

US health regulators released briefing documents Friday morning questioning the benefit of Vertex Pharmaceuticals’ combination therapy for cystic fibrosis patients. Ahead of an advisory panel review, scheduled for Tuesday, May 12, US Food and Drug Administration (FDA) staff reviewers questioned one of the two drugs in the combination cystic fibrosis …

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FDA Grants AbbVie’s Blood Cancer Drug Breakthrough Therapy Status

US health regulators have granted Breakthrough Therapy designation to AbbVie and partner Genentech’s blood cancer drug. AbbVie announced that the US Food and Drug Administration (FDA) granted breakthrough status to its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech …

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FDA Panel Recommends Approval of Amgen’s T-Vec in Melanoma

This week the US Food and Drug Administration (FDA) shared its concerns about the design of Amgen’s study evaluating its experimental melanoma treatment, talimogene laherparepvec (T-VEC), however this did not sway the agency’s advisory panel, which voted overwhelmingly in favor of the drug candidate. The agency’s independent Oncologic Drugs Advisory …

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FDA Issues Three Final Guidance Documents on Biosimilars

The US Food and Drug Administration (FDA) has issued three long-awaited documents with final guidance on biosimilars. In 2010, the agency passed the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act. In 2012, the FDA released the first guidance documents in draft form. …

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Genzyme’s Fabry Disease Drug Granted FDA Fast Track Status

US health regulators have granted a speedy review for Genzyme’s investigational drug for treatment of a rare lysosomal storage disorder. Genzyme, a Sanofi company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy …

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Hospira Highlights the Importance of Extrapolation for Successful Development of Biosimilars Market

Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week. The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration …

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SolaranRx’s Advanced Melanoma Candidate Receives FDA Orphan Drug Status

Today, SolaranRx, Inc. announced that US health regulators have granted orphan drug designation to its lead drug candidate in development for skin cancer. The “theranostics” – the merger between therapeutics and diagnostics – company said that the US Food and Drug Administration (FDA) has granted Orphan Drug status to its …

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