Sanofi SA is hoping an oral successor to Astrazeneca plc’s Faslodex (fulvestrant) could be a significant moneyspinner as it seeks to re-establish itself as a major player in oncology – and is pushing ahead with clinical trials to get it to market ahead of rivals. The Paris-based pharma has announced it is to start a new phase III trial of its second-generation oral selective estrogen receptor degrader (SERD) drug, amcenestrant, targeting high-risk patients with early breast cancer who need adjuvant drugs to suppress formation of secondary tumors after surgery.

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology's annual meeting, including: Alligator, Amgen, Antengene, Beigene, Deciphera, Eli Lilly, Exelixis, Gilead, Magenta, Novartis, Phio, Puma, Spectrum, Tarveda, Yingli.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ortho Regenerative Technologies, Pharmaessentia USA, Pharming Group, Regeneron, Visen.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Akoya, Auransa, Bioasis, BMS, Catalyst, Celgene, , Cyclerion, CNS, IGM, Innovent, Kye, Medunik, Pharvaris, Polarisqb, Roche, Surface.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Acadia, Advaccine, Albireo, Alzheon, Beyondspring, Galapagos, Gilead, Mirum, Point, Precision, Valbiotis, Valneva, Vincerx, Virios, Zynerba.

Biopharmas raising money in public or private financings, including: Cyclerion, Imaginab, Monte Rosa, Ocuphire, Social Capital.

New hires and promotions in the biopharma industry, including: Astrazeneca, Delix, Janux, Kura, Ovid.

Preparing for the full implementation of the 2013 Drug Supply Chain Security Act (DSCSA), the FDA finalized two guidances June 3 and released two draft guidances to help supply chain partners comply with the law’s requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.

The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant?olaparib?after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.”