As the conflict in Ukraine intensifies following the Russian invasion, hundreds of clinical trials could be in jeopardy amid the chaos and destruction of war, with pharma giant Merck & Co. Inc. saying it is putting recruitment for dozens of studies on hold. Read More
Partners Sanofi SA and Swedish Orphan Biovitrum AB (Sobi) said regulatory submissions are expected this year for once-weekly factor VIII therapy efanesoctocog alfa in hemophilia A following top-line success in a pivotal phase III study, which showed a clinically meaningful prevention of bleeds in people with severe disease receiving prophylaxis over 52 weeks. The drug, also known as BIVV-001, has fast track and orphan designations in the U.S., and the companies are banking on its extended half-life to go up against blockbuster bispecific antibody Hemlibra (emicizumab) from Roche Holding AG as well as a potential gene therapy from Biomarin Pharmaceutical Inc. Read More
Ahead of data due any day from Turning Point Therapeutics Inc. with repotrectinib (repo) in ROS1-positive non-small-cell lung cancer (NSCLC), CEO Athena Countouriotis said her firm’s product already is differentiating itself from the likes of Xalkori (crizotinib, Pfizer Inc.) and Rozlytrek (entrectinib, Roche Holding AG). Read More
An analysis of brain scans of participants in the UK Biobank has shown there are significant differences between the condition of the brain before and after mild COVID-19 infection. These included a reduction in overall brain size, reduction in grey matter thickness in the orbitofrontal cortex and hippocampal gyrus, and changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex. Infected participants also showed, on average, a larger cognitive decline than participants who had not contracted COVID-19. Read More
Inxmed Co. Ltd. has raised $50 million in a series B round to support clinical trials of its lead candidate, IN-10018, for the treatment of multiple cancers in both the U.S. and China. Inxmed plans to use the funds to invest in trials of IN-10018, bring more stroma-targeting candidates into clinic trials, and improve the firm’s R&D capabilities. Read More
After more than 50 years of trying, the U.S. FDA is finally withdrawing approval of Potaba (potassium aminobenzoate) tablets, capsules, powder, and other forms as well as any identical, related or similar products. Read More
If the U.S. SEC goes forward with amendments it proposed March 9 to enhance and standardize cybersecurity-related disclosures, public biopharma and med-tech companies will have more reporting to do. Read More
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Akeso, Apex, Genmab, Inventiva, Ixaka, Revance, Seelos, Tetra. Read More
