The ACTIV-3 phase III study testing Eli Lilly and Co.’s COVID-19 antibody candidate, LY-CoV555, which was paused two weeks ago following a participant’s unexplained illness, has now been halted, the company reported Oct. 26.

The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atai Life, Cytodyn, Edigene, Exelixis, Kala, Moderna, Nektar, Pfizer, Prevail, RDIF, Vanda.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alterity, Alzamend, Amerimmune, Appili, Bioinvent, CASI, Compugen, Daewoong, Effector, Eloxx, Essa, Fusion Antibodies, Hemogenyx, Histogen, Immunoprecise, Immunos, Lodo, Neximmune, Novasep, Ology, Phosplatin, Probiogen, Regenxbio, Roche, Sareum, Sensorion, Twist, Vaxil.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerpio, Alligator, Alzheon, Amgen, Bridgebio, Catabasis, Eisai, Ellodi, Genetx, Iveena, Lilly, Novavax, Olatec, Oncolytics, Pfizer, Phoenix Tissue Repair, Prilenia, Rafael, Reata, Scholar Rock, Sumitomo Dainippon, Syntrix, Takeda, Transgene, Ultragenyx.

Interest in testing the mettle of three widely available drugs against COVID-19 gained traction Monday, led by suggestions that daily low-dose aspirin might lower the risks of complications and death from the disease.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Bayer, Bioinvent, Bioxcel, Forte, Janssen, Nicox, Nitric Oxide Innovations, Passage, Santen, Sesen, Spectrum, Tracon, Y-mabs.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allakos, Anaptysbio, Astrazeneca, Biovaxys, Cohbar, Collegium, Contrafect, Cytodyn, Geovax, GSK, Lidds, Moderna, Novartis, Olema, Quell, Resverlogix, Revolution, TFF, Titan.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Allakos, Allergy, Amarin, Ana, Arcutis, Atyr, Biocardia, Biophytis, Biosig, Cingulate, Crinetics, Exelixis, Forma, Galera, Glycomimetics, Gmax, Hifibio, Kiniksa, Mustang, Nanobiotix, NBE, Novartis, PTC, Regeneron, Rexgenero, Sanofi, VBI.

With more than two months left in 2020, it is imminently clear that the $147.3 billion in biopharma projected deal values will likely rise above last year’s record of $160.3 billion, considering the average value per month more than covers the gap. Mergers and acquisitions are currently tracking in fifth place over the past seven years with projected values at $134.7 billion.