Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir).
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.
One of 19 children dosed with an experimental gene therapy for Sanfilippo syndrome has died following the treatment, given as part of a phase II/III trial of the medicine run by its developer, Paris-based Lysogene SA. The trial has been on clinical hold since June, but the immediate cause of the death is unknown, the company said.
Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
Voicing the frustrations of an industry alternately battered and lauded amid a politicized pandemic, leaders of the Biotechnology Innovation Organization (BIO) on Tuesday called for substantive changes they said are necessary to maintaining America's biomedical leadership.
Johnson & Johnson said it has temporarily paused further dosing of its adenoviral vector-based COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant. Trial enrollment is also on hold while the company awaits a recommendation on how to proceed from the study's data safety monitoring board.
An NIH-sponsored phase III trial testing Eli Lilly and Co.'s SARS-CoV-2 neutralizing antibody candidate, LY-CoV555, alongside the Gilead Sciences Inc. antiviral Veklury (remdesivir) has been paused at the request of its data safety monitoring board, the company told BioWorld.
Astrazeneca plc said it has received about $486 million from the U.S. government to support the development and supply of a long-acting antibody combination under evaluation for the prevention and treatment of COVID-19. Phase III trials of the candidate, AZD-7442, are slated to begin later this month, the company told BioWorld. One trial will enroll more than 6,000 adults for the prevention of COVID-19 with additional trials set to enroll about 4,000 adults for the treatment of the infection, the Cambridge, U.K.-based company said.
