More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance. Read More
CEO Samantha Singer said Abata Therapeutics Inc. “spent a considerable amount of time finding the right indication” for its approach, which deploys autologous regulatory T cells (Tregs) made to express T-cell receptors (TCRs). That disease is progressive, non-relapsing multiple sclerosis (MS). “We’re going to be able to succeed with these patients where other options have failed,” she told BioWorld. Read More
Tvardi Therapeutics Inc., a company targeting a protein essential to cancer cells' survival and immune evasion, closed a $74 million series B financing. The round will help it advance candidates through multiple midstage trial readouts in cancer and fibrosis, the Houston-based company said. Read More
Glaxosmithkline plc CEO Emma Walmsley has set out further details of the company’s forthcoming split, saying that the firm’s late-stage pipeline could help deliver sales of more than £33 billion by 2031. Read More
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod. Read More
It has been a bumpy rollercoaster ride for many biopharma companies throughout the pandemic, but overall, the 17 firms that make up BioWorld’s Infectious Disease Index are coming out ahead this year with stocks up by 44.8%. Read More
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. Read More
Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines. Read More
The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H). Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm. Read More
New and updated preclinical and clinical data presented by biopharma firms at The International Liver Congress – The Annual Meeting of the European Association for the Study of the Liver, including: Antios, Arrowhead, Assembly, Brii, Durect, Enanta, Mirum. Read More
Biopharmas raising money in public or private financings, including: Bioasis, Biocytogen, Bioxcel, Century, Cyteir, Glycomine, Hutchmed, Immuneid, Orum, Strand, Vita. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aarkus, Aleta, Alzheon, Celsion, Cerecor, Chemomab, Cocrystal, Dermtech, Etherna, Kedrion, Liminal, Mercaptor, Microbiotica, Mynd, Public Health Vaccines, Qu, Recursion, Scancell, Sorrento, SQZ, Tessa, Titan, Tiziana, Xenter. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algenex, Antares, Astrazeneca, Boehringer Ingelheim, Caladrius, Fennec, Grace, Xentria. Read More
