Here are the latest stories being discussed in biopharma today:
Janet Woodcock Reflects on FDA Tenure
As her tenure at the Food and Drug Administration (FDA) comes to an end, long-time official Janet Woodcock reflects on her time at the agency. Woodcock, who has served in numerous leadership roles including acting commissioner, deputy commissioner, and director of the Center for Drug Evaluation and Research (CDER), shared her thoughts on a number of topics, including the advisory committee system, preparedness for the next pandemic, and the controversial approval of Sarepta’s drug eteplirsen in 2016.
Geron’s MDS Drug to Undergo FDA Review in March
The FDA has scheduled an Oncologic Drugs Advisory Committee in March for Geron’s myelodysplastic syndromes (MDS) drug imeletelstat. The injectable drug is designed to treat anemia in adult patients dependent on transfusions. The FDA’s decision is expected by June 16.
GSK Targets Expanded RSV Label in Europe to Compete with Pfizer’s Abrysvo
GSK is eyeing an expanded respiratory syncytial virus (RSV) vaccine label in Europe to include adults aged 50 and above. If approved, it would make its vaccine the first in Europe to extend protection to this age group. Pfizer’s Abrysvo is also approved for this demographic, as well as newborns.
FDA Updates Clinical Trials Reporting Guidelines
The FDA has released draft guidance advising clinical trial sponsors to include race and ethnicity information in proposed product labeling. The document also extends its scope to include observational studies within guidance for clinical trials.
New FDA Guidelines for CAR-T and Gene Therapies Back Accelerated Approval
The FDA finalized two guidance documents to assist sponsors developing gene therapies using genome editing and ex-vivo manufactured CAR-T cell products.
Natera Awarded $96M in Patent Lawsuit Against CareDx
The genetic testing company Natera has been awarded $96M+ in a patent lawsuit against CareDx. The lawsuit stemmed from a dispute over blood tests that detect kidney transplant rejections. CareDx has vowed to contest the judgment.
