As Merck & Co. Inc.’s whopper proposal to take over Prometheus Biosciences Inc. for $10.8 billion faded from the ever-churning headlines, officials of the pharma heavyweight set about answering questions with regard to plans for the newly gained PRA-023, a humanized monoclonal antibody that targets tumor necrosis factor-like ligand 1A (TL1A). Read More
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR). Read More
Pipeline Therapeutics Inc., which received U.S. FDA approval to move into a phase Ib/IIa study of PIPE-307 in relapsing-remitting multiple sclerosis (RRMS) last year, will be advancing the oral, small-molecule muscarinic M1 receptor antagonist in collaboration with Janssen Pharmaceutica NV in an agreement that could be worth more than $1 billion. Read More
Despite concerns about a limited dataset to study, the urgent need to treat one of the toughest and most deadly infections propelled a U.S. FDA advisory committee to unanimously support the NDA for Entasis Therapeutics Inc.’s sulbactam-durlobactam (Sul-Dur). Sul-Dur, an injectable combination of beta-lactam antibiotic and beta-lactamase inhibitor for treating adults with hospital‐acquired bacterial pneumonia and ventilator‐associated bacterial pneumonia caused by susceptible strains of carbapenem-resistant Acinetobacter baumannii infections, has a May 29 PDUFA date. Read More
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine. Read More
Complement Therapeutics GmbH raised €72 million (US$79.4 million) in a series A round to move into the clinic a novel gene therapy for treating geographic atrophy secondary to dry age-related macular degeneration. It’s the largest series A round completed in Europe so far this year. Read More
Heterogeneity, in both tumors and their microenvironment, limits the success of current cancer treatments. But it also provides opportunities. Heterogeneities “are not barriers to therapy, they are vulnerabilities to be exploited,” was how David DeNardo described his take at the 2023 annual meeting of the American Association for Cancer Research (AACR) on Sunday. Read More
The artificial intelligence-first approach to drug discovery may be boosting productivity but has also exposed the fact that in silico design can only go so far. At some point it will be necessary to revert to the conventional method and synthesize a protein and do an experiment. Now newco Adaptyv Bio aims to smooth this transition by applying cell-free systems and micro fluidics to enable proteins to be synthesized and validated at nano scale. Read More
New hires and promotions in the biopharma industry, including: Amarin, Biohaven, Cormedix, Enlivex, Foresee, HLS, KBI, Rapid Dose, Regeneron. Read More
New and updated clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: 23andme, Affimed, Astrazeneca, Genentech, Harbour Biomed, Humanigen, Immune-Onc, Innovent, Mina, Morphosys, Pieris, Quanta, Renovorx, Tempest. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Gilead, Mindmedicine, Minghui, Ocugen, Sunstone, Travere, Zenshine. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affini-T, Akthelia, Argenx, Athenex, Biomed, Caris, Eisai, Enzolytics, Flare, Genmab, Geovax, Gilead, Graf, Navidea, Meilleur, Nkgen, Smart Immune. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Eli Lilly, Horizon, Ips, Minghui, Nicox, NS, Ocumension, Pfizer, Soligenix. Read More
