Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots: The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…

ByRidhi RastogiJuly 27, 2026

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AstraZeneca Reports the P-III Data on Sone-Ve for CLDN18.2-Positive Advanced G/GEJ Cancers

Shots: AZ reported P-III (CLARITY-Gastric01) data evaluating Sonesitatug vedotin (Sone-Ve; 2.2 or 1.8mg/kg, Q3W) vs investigator’s choice in 2L & later-line therapy for advanced or metastatic gastric, GEJ, or EAC with CLDN18.2 expression in ≥25% of tumour cells by IHC at any intensity Stage 2 continued with 2.2mg/kg as the recommended dose, with the trial…

ByRidhi RastogiJuly 27, 2026

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Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Shots: The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD) The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiJuly 27, 2026

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argenx to Acquire Forte Biosciences for $2.2B

Shots: argenx has entered into a definitive agreement to acquire Forte Biosciences, strengthening argenx’s innovative immunology portfolio with FB102 As per the deal, argenx will acquire Forte Biosciences for $77/share in cash, representing a total equity value of ~$2.2B; closing is expected in Q3’26 FB102 is an anti-CD122 antibody showing clinical PoC in vitiligo & celiac disease, with…

ByRidhi RastogiJuly 27, 2026

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NewAmsterdam and Menarini Report the CHMP Positive Opinion for Ubeslo and Evlarco for Primary Hypercholesterolemia

Shots: The CHMP has recommended Ubeslo (obicetrapib 10mg) & Evlarco (10mg obicetrapib + 10mg ezetimibe FDC) for pts with primary hypercholesterolemia, both HeFH & non-familial or mixed dyslipidemia; EC decision expected in H2’26 & will be valid across 30 EEA states Opinion was supported by extensive clinical data assessing obicetrapib, incl. the P-III (BROADWAY, BROOKLYN…

ByRidhi RastogiJuly 27, 2026

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Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Shots: The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEA Approval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHD In two adult studies, both Simtriyo dose groups…

ByRidhi RastogiJuly 27, 2026

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Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Shots: Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…

ByRidhi RastogiJuly 24, 2026

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Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots: The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

ByRidhi RastogiJuly 24, 2026

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Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 &…

ByRidhi RastogiJuly 24, 2026

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Eli Lilly Reports P-III (TRIUMPH-2 and TRIUMPH-3) Results on Retatrutide for Obesity

Shots: TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, while TRIUMPH-3 assessed retatrutide (9 or 12mg, QW) in 1949 pts with severe obesity & CV disease; trials used a stepwise dose-escalation approach at Q4W In TRIUMPH-3, 12mg reduced TGs, non-HDL cholesterol, systolic BP, waist circumference, &…

ByRidhi RastogiJuly 24, 2026

Ridhi Rastogi

Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

AstraZeneca Reports the P-III Data on Sone-Ve for CLDN18.2-Positive Advanced G/GEJ Cancers

Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

argenx to Acquire Forte Biosciences for $2.2B

NewAmsterdam and Menarini Report the CHMP Positive Opinion for Ubeslo and Evlarco for Primary Hypercholesterolemia

Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Eli Lilly Reports P-III (TRIUMPH-2 and TRIUMPH-3) Results on Retatrutide for Obesity

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