Two major papers on repurposed drugs for COVID-19 by researchers from Brigham and Women’s Hospital face intense skepticism from the research community, prompting the editorial boards of TheNew England Journal of Medicine and The Lancet to publish Expressions of Concern on the validity of the underlying data. Such expressions are often the first step toward an outright retraction. Read More
Prilenia Therapeutics BV, a private company developing an experimental therapy for Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS), has raised $62.5 million in a series A financing round to support new trials in the indications, both of which are expected to yield top-line data by the end of 2022, CEO Michael Hayden told BioWorld. Read More
LONDON – With results of its first phase I trial imminent, inflammasome specialist Nodthera Ltd. has raised $55 million in a series B round, providing funding for phase II proof-of-concept studies and to advance a second, brain-penetrant, compound to the clinic. Read More
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong. Read More
Security and safety, like beauty, are in the eye of the beholder, especially in the time of a politicized pandemic. “The U.S. drug supply chain is safe, and the supply chain is secure,” Judith McMeekin, associate commissioner for regulatory affairs at the FDA, testified before the Senate Finance Committee Tuesday. Read More
New interim phase II data from Replimune Group Inc., of Woburn, Mass., show RP-1 and Opdivo (nivolumab, Bristol-Meyers Squibb Co.) produced multiple complete responses and a high rate of deep responses in anti-PD-1/anti-CTLA-refractory melanoma. Read More
HONG KONG – China’s Shanghai Junshi Biosciences Co. Ltd. has struck a deal with Merck KGaA for a clinical trial program in China to investigate the efficacy and safety of Junshi’s anti-PD-1 monoclonal antibody (MAb), Tuoyi (toripalimab) in combination with Merck’s Erbitux (cetuximab) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck (SCCHN). Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allakos, Amgen, Aprea, Astrazeneca, Beyondspring, BMS, Complexa, Horizon, Innovent, Janssen, Lilly, Novartis, Replimune, Spring Bank, Valerion. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Clarity, FSD, Genmab, Novartis, Pierre Fabre, Revive, Specialised Therapeutics, Treadwell, Trevena. Read More
