In a move that is sure to raise debate about the path forward for biosimilars, Abbott Laboratories has filed a citizen’s petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis. On what grounds? Abbott argues that the FDA would have no choice but to use trade secrets submitted to the agency when approval for Humira was first sought.
If you like this story, please see our blog titled “Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”
The U.S. government will help drug companies find treatments for a host of diseases through a new collaboration in which researchers will test experimental drugs provided by manufacturers.
If you like this story, please see our blog titled “The Market for Cell Culture Media Continues Expansion”
Novavax started enrollment of a Phase I clinical trial of its A/H5N1 vaccine to prevent bird flu. The vaccine is part of the company’s $179 million contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (HHS BARDA) to develop a vaccine against a potential bird flu pandemic.
If you like this story, please see our blog titled “First Cell Culture Based Vaccine Plant in the US”
Profectus Biosciences won a $5.4 million five-year grant from the National Institute of Allergy andInfectious Diseases (NIAID) to support the development of a trivalent vaccine that protects against infection by all major strains of the Ebola andMarburg filoviruses.
If you like this story, please see our blog titled “Safer Vaccine Manufacturing Defined Animal-free Media for the Production of Vaccines from Diploid Cells”
Researchers at UPMC and Stanford University hope they can enhance recovery by infusing millions of stem cells directly into patients’ brains. Using cells developed by a San Francisco-area company called SanBio, the two institutions have carried out the procedure on six patients so far and plan to enroll another 12 in a two-year safety trial of the new therapy.
If you like this story, please see our stem cell blog titled “Exciting Treatment Possibilities With Stem Cells What is the Best Cell Culture Method”
The stem cell specialist ReNeuron said it had successfully raised over £6 million to fund its ongoing research and development programme.
If you like this story, please see our blog titled “Culture and Expansion of Stem Cells in Stirred Suspension Bioreactors Could Provide Key in Large Scale Manufacturing”