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Pearce IP BioBlast®: w/e 16 July 2021

by | Jul 19, 2021

12 Jul 21 | Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

13 Jul 21 | As published in Nature Communications, Australian researchers from the Doherty Institute and Peter MacCallum Cancer Centre were successful in harnessing CRISPR to target the virus that causes COVID-19 and suppress viral replication in mammalian cells.

14 Jul 21 | US | The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro injection compared to a prefilled syringe. Amgen must provide a written response within 15 working days from the date of receipt of the letter.

14 Jul 21 | UK | The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

15 Jul 21 | Bio-Thera Solutions announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).

16 Jul 21 | Celltrion announced pre-clinical in vivo studies of CT-P59 (regdanvimab) demonstrated strong neutralising activity against the Delta variant of COVID-19. Celltrion reported a 100% survival rate after a clinically relevant dose compared to 0% for the placebo group, with significant protection against body weight loss after viral challenge. A therapeutic dosage of CT-P59 also significantly reduced the viral load and inflammation in the lungs compared to non-treated controls.

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