The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinuvel, Genmab, Moderna, Oryzon, Polaryx, Seagen.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atyr, Celltrion, China SXT, Dnatrix, Dyno, Exscientia, Gain, GSK, Incyte, M6P, Macrogenics, Mindmed, Mindshift, Nuvation, Olix, Panacea, Portage, Protalix, Renji, Rentschler, Repertoire, Sandoz, Sarcomed, Vyne.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Acer, Actinium, Almirall, Artios, Athenex, Benevolentai, Kite, Mesoblast, Olatec, Outlook, Urovant.

Biopharmas raising money in public or private financings, including: Adagene, Allarity, Applied Therapeutics, Athira, Biondvax, Cyteir, FSD, GT Biopharma, Iterum, Kadmon, Kalvista, Medincell, Moleculin, Neximmune, Ocugen, Predictive Oncology, Pulmatrix.

New hires and promotions in the biopharma industry, including: Antios, Biodelivery Sciences, Contrafect, Kromatid, Recro, Retrotope, Sophia Genetics, Surface Oncology, Tryp.

Quarterly snapshots from biopharma companies with marketed products, including: Alkermes, Alnylam, Exelixis, Karyopharm, Vanda.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adnab, Aerami, Algernon, Alterity, Antibe, Apollomics, Applied Biomath, Arch, Area, Azurrx, Basilea, Bostongene, Camargo, Cellular Biomedicine, Chance, Charles River, Compass Pathways, Edison, Eikonizo, Eloxx, Evotec, Freeline, Hengrui, Herantis, Homology, Hoth, Jemincare, Jubilant, Lannett, Lassen, Merck & Co., Nanoform, Nuance, Otsuka, Pfizer, PPD, Respirerx, Revitope, Sigilon, Sorrento, Stemedix, Synaptogenix, Taysha, Tmunity, Tryp, Yingli.

In its first decision on excessive drug pricing, the European Commission (EC) accepted a commitment Feb. 10 from Aspen Pharmacare Holdings Ltd. to immediately drop the price of six essential cancer drugs in Europe by an average of 73% and to continue to supply the drugs for at least the next five years.