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Genentech
NEWS

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…
November 18, 2025

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Ionis and Otsuka
NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…
November 17, 2025

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ITM
NEWS

ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The US FDA has accepted an NDA of 177Lu-edotreotide (ITM-11) for the treatment of GEP-NETs, with a PDUFA goal date of Aug 28, 2026 NDA was supported by the P-III (COMPETE) trial assessing ITM-11 vs everolimus (N=309) as a 1/2L treatment of inoperable, progressive, SSTR+ Grade 1 or 2 GEP-NETs, which met its 1EP of…
November 13, 2025

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Novartis
NEWS

Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria

Shots: The P-III (KALUMA) trial assessed KLU156 (ganaplacide/lumefantrine, or GanLum) vs Coartem for treating acute, uncomplicated malaria due to Plasmodium falciparum in 1,668 adults & children (≥10kg) across 12 African countries Trial showed non-inferiority to the SoC (1EP), achieving a PCR-corrected adequate clinical & parasitological response (APCR) of 97.4% vs 94% (post hoc per-protocol cure…
November 13, 2025

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NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…
November 12, 2025

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Genentech
NEWS

Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

Shots: Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks. Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…
November 10, 2025

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Merck
NEWS

Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

Shots: Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25 Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
November 10, 2025

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