FDA News

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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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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Pfizer’s Antibody-Drug Conjugate Succeeds in Phase 3 Study and its Xalkori Receives Breakthrough Therapy Designation

Pfizer Inc. announced positive news for two of its cancer drugs today. The company said that US health regulators granted its Xalkori (crizotinib) Breakthrough Therapy designation, and, separately, Pfizer announced that its investigational antibody-drug conjugate (ADC) met one of its main goals in a late-stage leukemia trial. The US Food …

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Merck’s Keytruda Demonstrates Positive Results in Three Different Cancers

Merck’s immunotherapy Keytruda (pembrolizumab) demonstrated positive results in three different cancers, including lung cancer, melanoma, and mesothelioma, according to presentations at the American Association for Cancer Research (AACR) conference in Philadelphia. At the cancer research meeting Sunday, Merck presented new Keytruda data, showing an overall response rate (ORR) of 19 …

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