Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
Buying out Immunogen Inc. in a whopper cash deal valued at about $10.1 billion, Abbvie Inc. has major plans for an expanded label on the antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx), already approved for treating platinum-resistant ovarian cancer.
Companies have invested billions for decades to crack the problem of treating the deep complexities involving stromal cancers, Phenomic AI CEO Girish Aakalu told BioWorld. Now he and his company are on the receiving end as they enter a new collaboration with Boehringer Ingelheim GmbH.
Reports of T-cell malignancies, including lymphoma, have the U.S. FDA investigating the risks for patients who received certain autologous CAR T-cell immunotherapies.
Cancer Research UK (CRUK) is worried that rising prices and its total dependence on public donations mean its funding model is becoming unsustainable. The charity is calling on the U.K. government to step in and plug a £1 billion (US$1.23 billion) shortfall it said will open up over the next decade, in order to maintain investment at 2019 levels in real terms.
Springworks Therapeutics Inc.’s nirogacestat became the first drug indicated specifically for desmoid tumors, as well as the first gamma-secretase inhibitor to win marketing approval, winning a U.S. FDA nod on the anticipated PDUFA date of Nov. 27. Branded Ogsiveo, nirogacestat has breakthrough therapy, fast track and orphan designations.
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
Boehringer Ingelheim GmbH has acquired T3 Pharmaceuticals AG for CHF450 million (US$507.5 million) to gain access to a technology that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor microenvironments.
Morphosys AG’s rare blood cancer treatment hit its phase III primary endpoint but missed statistical significance on a secondary endpoint, sinking the stock for the day. Top-line data from the study treating JAK inhibitor-naïve patients who have the rare blood cancer myelofibrosis showed the combination of pelabresib, a BET inhibitor, and the JAK inhibitor ruxolitinib produced a statistically significant improvement in spleen volume reduction, which was the primary endpoint.
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