An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.

Intellia’s gene editing approach yields positive early data in HAE, shows further promise in ATTR amyloidosis

Intellia Therapeutics Inc. reported impressive, though very early stage, clinical data showing NTLA-2002, its systemically administered CRISPR candidate for hereditary angioedema (HAE), could substantially reduce levels of the kallikrein protein as well as the incidence of HAE attacks. The company also reported updated data from its lead in vivo genome editing candidate, NTLA-2001, in patients with transthyretin amyloidosis, further supporting efforts to develop the drug as a one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein in AATR amyloidosis. The data appear to bode well for further advancement of Intellia’s therapeutic approach, though shares (NASDAQ:NTLA) slipped Sept. 16, trading down 6% at midday.

Astrazeneca’s danicopan hits phase III endpoint as add-on therapy in PNH

A prespecified interim analysis revealed that Astrazeneca plc’s oral factor D inhibitor danicopan met the primary endpoint of a phase III trial as an add-on therapy for patients with paroxysmal nocturnal hemoglobinuria (PNH) who were also taking a C5 inhibitor, but who still experienced extravascular hemolysis. The company is not disclosing the data, so the magnitude of the treatment effect and its likely impact on patients’ quality of life is not clear at present. But the study appears to have generated what it was looking for.

WHO pulls COVID-19 recommendations from GSK-Vir, Regeneron antibodies

Newly updated guidelines from the World Health Organization (WHO) caution against the COVID-19 treatments sotrovimab from GSK plc-Vir Biotechnology Inc. and Regeneron Pharmaceuticals Inc.’s Regen-Cov (casirivimab + imdevimab). Omicron, the group said, has rendered the monoclonal antibodies ineffective.

Sex differences in brain tumor metabolism suggest the need to adapt treatments

Sex differences at the cellular level could explain why men respond less well to glioblastoma (GBM) treatments, according to a study led by the Washington University School of Medicine. The researchers found that male and female GBM tumor cells had different metabolic needs. GBM cells from male surgical samples absorbed more glutamine and had different nutritional preferences for amino acids.

The BioWorld Insider Podcast: $1B+ biopharma deals keep values afloat, even amid muted volume

BioWorld writers bring you the details of new R&D alliances, financings, IPOs and M&A every day. These stories are the heartbeat of the relationships between industry giants and their smaller, more innovative peers. But what's the top-line read for dealmaking these days? With nearly 1,000 biopharma deals completed through early August amid a volatile economic climate, there's a lot to talk about. Join the BioWorld Insider podcast as we talk with Senior Analyst Karen Carey, whose data-driven research delivers a detailed picture of the ups and downs.

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AB Science, Alnylam, Aro, Ascletis, Benitec, Biojiva, Brainstorm Cell, Bristol Myers Squibb, Cage, Candel, Celsion, Celularity, Curevo, Eloxx, Enzolytics, Evofem, Excision, Gilead, GSK, Imara, Inhibikase, Inversago, J Ints, Jasper, Kymera, Lipocine, Mallinckrodt, Navidea, Omeros, Peptistar, Pfizer, Pharvaris, Quince, Regeneron, Revance, Sorrento, Syros, Tagcyx, Tyme