A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade. Read More
As the Sept. 21 PDUFA date looms for arimoclomol from Zevra Therapeutics Inc. in Niemann-Pick type C (NPC), the U.S. FDA’s newly formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) decided in favor of the drug. Read More
Tokyo-headquartered Otsuka Pharmaceutical Co. Ltd. said Aug. 1 that it will acquire Boston-based Jnana Therapeutics Inc. through a potential $1.125 billion M&A deal. Under the terms, Otsuka will work to close the transaction by the third quarter of 2024, with $800 million paid out to Jnana shareholders, along with up to $325 million in additional development and regulatory milestones payments. Read More
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920. Read More
To be successful, CAR T-cells need a balance between being effective and overkill. Researchers from the University of Pennsylvania and Vittoria Biotherapeutics Inc. have eliminated the CD5 signaling pathway of their CAR Ts to prevent the immunosuppressive brake effect. In return, this improved their proliferation and antitumor activity in T cell lymphomas. Read More
Biopharma financings soared to $73.76 billion in the first seven months of 2024, marking a substantial 102% jump compared to the $36.47 billion accumulated in the same period in 2023. This amount places 2024 just behind the record-setting years of 2020 ($80.42 billion) and 2021 ($80.74 billion) in terms of funds raised through July. The $2.04 billion secured in July also is an increase from the $1.87 billion raised in June. Read More
Vir Biotechnology Inc.’s focus will look a little different for the latter half of 2024, as the San Francisco-based firm disclosed a restructuring that will cut about a fourth of its workforce and phase out programs targeting influenza and COVID-19 as well as vaccines developed using its T-cell-based viral vector platform. Read More
Karen Carey, BioWorld managing editor and chief analyst, takes a look at the numbers from the first half of 2024. She finds the first six months to be healthy for the biopharma market while the rest of the year is populated with question marks that include the U.S. presidential election and potential interest rate cuts. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, ALX, Eli Lilly, Kiromic, Neurosense, Otsuka, Regenxbio, Sound. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Biogen, Cerevel, Hillevax, Limmatech, Merck KGaA, Milliporesigma, Mirus, Paratek, Valneva, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Celltrion, Corvus, Healx, Immuneering, PDS, Prestige. Read More
