As expected, Viela Bio Inc. won FDA clearance for the humanized anti-CD19 monoclonal antibody Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a rare neuroinflammatory disease. Read More
Selecta Biosciences Inc., of Watertown, Mass., and Stockholm’s Swedish Orphan Biovitrum AB (Sobi) signed a licensing agreement for SEL-212, which is designed to control serum uric acid, reduce immunogenicity and allow for repeated monthly dosing when treating chronic refractory gout. Read More
Although the general markets have bounced around in June and the BioWorld Biopharmaceutical index has dipped almost 5% in the period, the uncertain capital environment has not affected investor appetite for biopharma IPOs. Read More
BEIJING – CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. raised another $100 million this week after securing $90 million in series A round in 2018. The funds will continue to go toward its lead program, JWCAR-029, a CAR T-cell product targeting CD19 that is now in a phase II study. Read More
LONDON – EU health ministers have given the go-ahead for the European Commission to negotiate COVID-19 vaccines contracts on behalf of all 27 member states, approving the use of a €2.3 billion (US$2.6 billion) emergency fund for down payments. Read More
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete. Read More
Whole genome sequencing is not part of treating patients in practice – or even involved in most clinical trials of drug candidates. But C2i Genomics Inc. is working to make that a reality. It applies pattern recognition to whole genome sequencing to create an individualized fingerprint for a given patient’s tumor. The New York-based startup has raised a $12 million series A round to back the development of its technology, which came out of Cornell and the New York Genome Center. Read More
BioWorld looks at translational medicine, including: Prozac for infectious disease; How CDK comes unglued; Macrophages rewire cholesterol metabolism for bacterial toxin defense; ApoE4’s role in Alzheimer’s blood vessels; HRAS-driven translation helps skin prevent tumors; Discovering pharmacological enzyme activators; Broad-spectrum antiviral has activity against Zika; Lifespan synaptic atlas gives developmental insights; NETS and mets. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Atox, Aura, Bone Therapeutics, Cytodyn, Lilly, Noveome, Novo, Octimet, Otsuka, Pulmocide, Respivant, Verrica. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agios, BMS, Celgene, Dcprime, Revive, Royalty, Scopus, Tonix, Trigemina. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Biovie, Kite, Leap, Viela, ZZ. Read More
A number of clinical trials hit primary endpoints in May, despite the COVID-19 pandemic, which still accounted for about 30% of the phase I through phase III news flow during the month. Read More
