Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea.
The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea. Other big pharmas, including Switzerland’s Novartis AG, Denmark’s Novo Nordisk A/S and China’s Wuxi Biologics (Cayman) Inc., are also making multimillion-dollar investments in the Asia-Pacific region, according to company announcements made in March 2024.
Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.
The RNAi therapeutic zilebesiran, which was the focus of a 2023 $2.8 billion deal between Alnylam Pharmaceuticals Inc. and Roche Holding AG, demonstrated significant systolic blood pressure reductions in patients with mild to moderate hypertension who were part of the Kardia-2 phase II study.
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.
Blueprint Medicines Corp. found a new U.S. commercialization home for Gavreto (pralsetinib) through an agreement with Rigel Pharmaceuticals Inc. potentially worth $117.5 million, now that Roche Holding AG has relinquished all rights. The product, a once-daily oral small-molecule kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions, received accelerated approval in 2020 by the U.S. FDA, under priority review and with orphan drug designation, to treat adults with metastatic RET fusion-positive non-small-cell lung cancer.
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”
Weeks after Roche Holding AG paid a $40 million milestone payment to partner Repare Therapeutics Inc. when the first cancer patient in the phase II Tapistry trial was dosed with camonsertib, the Basel, Switzerland-based pharma backed out of the 20-month-old deal.
