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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

FDA Law Blog: Biosimilars

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. 112-144 (2012). Importantly, because FDA has sovereign immunity from damages claims, sponsors trapped in S.

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Immuno-oncology market set to grow in billions, but access concerns remain

Pharmaceutical Technology

While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23. was powered by the advent of immune-checkpoint inhibitors, added Chalk.

Immunity 105
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GSK, Verily-backed Galvani starts trials of bioelectronic arthritis therapy

pharmaphorum

Lab studies have suggested that this type of stimulation can alter immune cells made in the spleen switching them from a pro-inflammation to an anti-inflammation state. Galvani is using its device to stimulate the splenic nerve, which sends signals to the spleen.

Immunity 109
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Women’s History Month Spotlight: Brigitte Askonas

Big Molecule Watch

Born one hundred years ago, Dr. Askonas contributed to our understanding of the origin and synthesis of antibodies and the body’s immune response. In 2007, she was awarded the Robert Koch Gold Medal, the leading international scientific prize in microbiology, and in 2012, an Honorary Doctorate by Cambridge University.

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The role of data science and text mining in the search for new therapies

pharmaphorum

“Text mining was also able to highlight new insights into the mechanisms of pancreatic cancer’s immune evasion, which refers to cancer cells’ ability to evade an immune response” . This was only discovered in 2012 and is a currently active area of research within pancreatic cancer.

Immunity 105
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Moderna Litigation Against BioNTech and Pfizer Stayed Pending IPR

Big Molecule Watch

Pfizer and BioNTech’s IPR petitions allege that the ‘127 and ‘600 patents are directed to “the use of mRNAs encoding any spike protein or spike protein subunit of any betacoronavirus, formulated in a broadly claimed lipid delivery system, to induce an immune response.”

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Transforming oncology with antibody therapeutics

European Pharmaceutical Review

Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity. 4 BsMAb amivantamab was designed to enhance adherence of tumour cells to macrophages and natural killer cells, to improve immune-cell mediated killing of cancer cells. 2012; 23(8): 6 – 9.