Biologics

CBER Approved Therapeutic ‘Firsts’ in FY 2017

CBER director Peter Marks says the Center approved several therapeutic “firsts” in FY 2017, representing significant achievements in fulfilling its mission to ensure that safe and effective biological products and related devices are available to the public. In the Center’s annual report, Marks identifies the new therapies as Novartis’ Kymriah (tisagenlecleucel), the first gene therapy approved in the U.S. to treat patients up to age 25 with some B-cell precursor acute lymphoblastic leukemia; Vericel’s MACI (autologous cultured chondrocytes on porcine collagen membrane), the first FDA approved product for repairing knee cartilage defects in adults that is grown from cells on scaffolds using healthy cartilage tissue from the patient’s own knee; ALK’s Odactra (dermatophagoides farinae and dermatophagoides pteronyssinus), the first allegenic extract to be administered under the tongue for treating house dust mite-induced nasal inflammation; and CSL Behring’s Haegarda (C1 esterase inhibitor subcutaneous (human)), the first subcutaneous preventive treatment option for hereditary angioedema.

Marks says the Center also “played an important role in protecting and promoting the public health against emerging infectious diseases such as Zika and Ebola.” In FY 2017, he writes, CBER completed expedited reviews of seven INDs for Zika vaccines and continues to advise HHS and international regulatory partners on Zika virus vaccine development. It also continued to provide strategic direction to national regulatory authorities addressing safety and efficacy concerns related to Ebola virus vaccines in development, Marks says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome