Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
GSK took Blenrep off the market last year after the multiple myeloma drug failed its confirmatory study. But GSK now says it has interim data showing Blenrep beat a blockbuster Johnson & Johnson drug in a head-to-head Phase 3 study testing it as an earlier line of therapy.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.
Tenpoint Therapeutics’ name refers to the time it takes for an image to hit the retina and be processed by the brain. The regenerative medicine startup is developing cell therapies it hopes restore that vision capability for patients with degenerative eye disorders.
An AstraZeneca and Daiichi Sankyo cancer drug achieved one of the main goals of a Phase 3 study in non-small cell lung cancer. But patient deaths were also reported in the study, and the companies disclosed few details about them.
AstraZeneca is paying $85 million to kick off an alliance with Quell Therapeutics focused on developing new cell therapies for autoimmune diseases. Type 1 diabetes and inflammatory bowel disease are the focus of the research collaboration.
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FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.
Syena, the latest company formed by startup creator Replay, is developing cancer treatments based on a type of immune cell called a natural killer cell. This NK cell therapy technology, licensed from The University of Texas MD Anderson Cancer Center, could overcome many of the limitations facing first-generation cell therapy.
The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.
GSK drug otilimab failed a Phase 3 test in rheumatoid arthritis. Though the antibody drug met the main goal in two other pivotal studies, GSK said the limited efficacy in the third study means the company will not seek regulatory approval.
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Respiratory syncytial virus has no approved vaccines anywhere in the world, but the chase to bring the first one to the market is heating up. GSK reported Phase 3 data that position it for regulatory submissions the pharma giant is planning for later this year. Pfizer is also on track to seek regulatory approvals for its RSV vaccine candidate.
When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the business. Pfizer said that selling its ownership in Haleon is keeping with its focus on developing innovative new medicines and vaccines.
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with its $2.1 billion acquisition of Affinivax. That biotech’s Phase 3-ready vaccine candidate addresses more bacterial strains than any pneumococcal vaccines currently available.
GlaxoSmithKline is further building out its cancer drug portfolio by acquiring Sierra Oncology, a biotech whose FDA-ready myelofibrosis drug has clinical data showing advantages over a blockbuster product marketed by Incyte. The deal comes as GSK prepares a spinoff of its consumer products as part of a broader strategy to hone its focus on specialty medicines and vaccines.
An Eisai drug that produced disappointing data in a myelodysplastic syndrome study is getting another shot under a newly launched Roivant Sciences subsidiary, Hemavant. Roivant executives say the small molecule could be a safer, more effective alternative to MDS therapies marketed by Bristol Myers Squibb.