Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Caribou, Clarity, Genmab, Immorna, Legend, Okyo, Rhythm, Tetra, Triastek.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bioinvent, Carmell, Eli Lilly, Emmaus, Iovance, Iveric, Kempharm, Novavax, Provention, Sanofi.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apim, Blue Water, Iaso, Microvascular,Nona, Nordic Nanovector, Pfizer Replay, Sensei, Umoja, XNK.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Azura, Cocrystal, Editas, Evaxion, Immunic, Kinevant, Kiora, Organicell, Pfizer, Takeda, Visen, Vyne.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180, Aelis, Algernon, Ayala, Beam, Bioxytran, Geneuro, GSK, Humanetics, Horizon, Inhibrx, Midatech, Mineralys, Monopar, Oncosec, Sirona, Skye.

Additional early-stage research and drug discovery news in brief, from: Athira, Biovaxys.

Pfizer Inc. and Biontech SE have initiated a phase I study to evaluate the safety, tolerability and immunogenicity of BNT-162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T-cell responses and potentially broaden protection against COVID-19.

An in-depth investigation of the underlying causes of pulmonary symptoms that in some cases persist for months following recovery from the acute stage of COVID-19 has found a distinctive proinflammatory signature in the plasma and airways of affected patients. The research could provide an explanation for the ongoing interstitial lung disease and fibrosis seen in patients who were hospitalized with severe COVID-19, and also point to neutrophils as a specific therapeutic target.

COVID-19 has vexed researchers, physicians and public health authorities since its emergence with an unexpectedly rapid rate of mutation. In addition to requiring constant adjustment of therapeutics and repeated vaccinations, the ever-changing virus has rapidly made scores of prognostic models irrelevant within months of development. Feinstein researchers appear to have met the challenge with an auto-updating model that predicts 28-day survival in patients hospitalized with COVID-19.