Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna. Read More
How to get reasonable efficacy in cancer without toxicity – problematic especially in older patients – is a dilemma made ever more poignant by the advent of CAR T therapies and bispecific antibodies, which have been showing overall response rates of about 70%, but with side effects that can severely limit their use. Invariant natural killer T cells may provide an answer, and New York-based Mink Therapeutics Inc. aims to find out. Read More
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome. Read More
Lee’s Pharmaceutical (HK) Ltd. and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., expanded their rights to lucinactant Surfaxin, lyophilized lucinactant Surfaxin LS and Aerosurf from Windtree Therapeutics Inc. in a $78.9 million global license deal to develop and commercialize the candidates for the treatment of preterm infants with respiratory distress syndrome and other potential indications. Read More
Having initiated its first two clinical trials in non-small-cell lung cancer since January, Nuvalent Inc. said it expects to unveil preliminary dose-escalation data before year-end. Ahead of the data, Nuvalent's phase I/II Arros-1 trial evaluating NVL-520, a kinase inhibitor, in patients with advanced ROS1-positive NSCLC and other solid tumors, continues to enroll participants. Read More
With financings, U.S. FDA approvals and mergers and acquisitions all tracking behind last year, why would clinical data be any different? According to BioWorld research, clinical trial reports are down by 16.2% this year. The number of efforts targeting the COVID-19 pandemic, as well as the proportion of data focused on infectious diseases, are also dropping. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Astrazeneca, Biomarin, Biontech, Century, Erytech, Iovance, Janssen, Moderna, Pfizer, Savara, Therapeutic Solutions. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avadel, AVM, Biocryst, Biocytogen, Clearmind, Elevatebio, Emerald, Finch, Jazz, Merck & Co., Skye, Stoke, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Astrazeneca, Biomarin, Biontech, Century, Erytech, Iovance, Janssen, Moderna, Pfizer, Savara, Therapeutic Solutions. Read More
