LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published in Nature Feb. 2. Read More
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics. Read More
Gilead Sciences Inc. is making a one-time $1.25 billion payment, with a commitment for a royalty that analysts predict could add as much $1.5 billion more, to Viiv Healthcare Ltd., in a deal designed to resolve all global pending or potential patent infringement claims relating to sales of HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The initial payment, recorded in the fourth quarter of 2021, put a significant dent in Gilead’s earnings per share but removes the uncertainty of a trial outcome and clears the way for future bictegravir-containing products. Read More
The U.S. Department of Justice (DOJ) reported Feb. 1 that it had recouped more than $5.6 billion in settlements in connection with False Claims Act litigation (FCA) in 2021, with $5 billion of that amount derived from action against the health care industry. Read More
The FDA has placed Logicbio Therapeutics Inc.’s phase I/II clinical trial of LB-001, an investigational AAV genome-editing therapy for treating pediatric patients with methylmalonic acidemia (MMA), on a clinical hold. So far, four patients have been dosed in the study and two have had serious adverse events related to the candidate, the company’s lead asset. Read More
Amid pressure to get a COVID-19 vaccine authorized for infants and toddlers sooner than later, Pfizer Inc. and Biontech SE initiated a rolling submission seeking to amend the U.S. FDA’s emergency use authorization for their mRNA vaccine to include children 6 months through 4 years of age. Read More
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president. Read More
HDT Bio Corp. looked at the world and saw health care inequity, so it built itself to help countries with developing economies help themselves. The company is bringing RNA technology for handling COVID-19 to underserved areas such as Brazil so they can develop, manufacture and distribute their own vaccine instead of relying on big pharma or developed-nation governments. Read More
The ultra-rare skin disease X-linked hypohidrotic ectodermal dysplasia (XLHED) can be a heavy burden for children, affecting structures in the skin including sweat glands, respiratory glands, and hair as well as teeth. Though lacking a specific treatment to date, a pivotal clinical trial planned by the Geneva-based nonprofit Esperare Foundation and Pierre Fabre SA could now help bring one about. Read More
New hires and promotions in the biopharma industry, including: Aclaris, Bluejay, Design, Diamedica, Iecure, Kronos, Kura, Mesoblast, Pfizer, Relief, Teclison, Vifor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aldeyra, Anavex, Arcutis, Biofrontera, Clarity, Cytokinetics, Immunitybio, Lava, Minerva, Neuvivo, Oncorena, Reviva, Sellas, Trevi, Windtree, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech Holdings, Anakuria, Atea, Aveta Biomics, Biosanapharma, Brickell, Carna, CSIR-Central Drug Research Institute, Eversana Life Science Services, Evoke, Janssen, Johnson & Johnson, Juvena, Mosaic Immunoengineering, Navitor, Neximmune, Novartis, Oak Hill, Pimera, Rutgers, Skye, SQZ, Takeda, Veru. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azafaros, Brand Institute, Denovo, Immune-Onc, Janssen, Moderna, Mydecine, Ose, Pharmather, Veloxis, Viiv. Read More
