Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose. Read More
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world. Read More
Vigil Neuroscience Inc. CEO Ivana Magovčević-Liebisch said the just-raised $90 million in series B money will let the company reach “a lot of value-generating milestones,” having been “moving extremely fast” in the year since it was founded. Read More
Bioworld’s Drug Developers Index is at its highest point this year, up 4.99%, despite some index members receiving FDA complete response letters and reporting lower-than-expected sales within the last month. Moderna Inc., with its mRNA-1273 COVID-19 vaccine gaining more traction worldwide, is largely responsible for the rise, with its own shares (NASDAQ:MRNA) up nearly 285%. Read More
Jnana Therapeutics Inc. closed a $50 million series B round and took the covers off its lead program, a small-molecule inhibitor of the solute carrier transporter SLC6A19, which it is prepping for clinical trials in phenylketonuria (PKU). Read More
Immunitas Therapeutics Inc., a company leveraging single cell analysis to identify and validate new drug targets, has closed $58 million in series B financing led by Agent Capital. The funds will be used to advance its lead program, the CD161 inhibitor IMT-009, into the clinic for testing against both solid tumors and hematological malignancies, pending approval of a forthcoming IND filing next year. Read More
Exevir Bio NV is honing its attack on the crowded market for COVID-19 antibodies, beginning clinical development of a potential subcutaneously administered drug targeting outpatients with early symptoms who are at risk of further progression. Read More
Voot Yin, co-founder and chief scientific officer of the Bar Harbor, Maine-based Novo Biosciences Inc., reached a settlement with U.S. Health and Human Services’ Office of Research Integrity over allegations that he faked data while conducting government-funded research at the Mount Desert Island Biological Laboratory in Maine. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptevo, Azurrx, Cabaletta, Cidara, Cinclus, Citryll, Exevir, Galecto, Geron, Innovent, Istari, Kintara, Kyowa Kirin, Marinus, Mei, Receptor, Telix, Tiziana, Transcenta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Agios, Amo, Anaptysbio, Angel, Beigene, Biomind, Biontech, BMS, Corvus, Diamond, Emmaus, Eusa, GSK, Moderna, Nflection, Novartis, Pfizer, Roche, Virpax. Read More