Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…

ByRidhi RastogiJune 29, 2026

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Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…

ByRidhi RastogiJune 29, 2026

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Shots: The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I…

ByRidhi RastogiJune 29, 2026

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Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The CHMP has recommended Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Opinion was backed by the global P-III (TROPION-Breast02)…

ByRidhi RastogiJune 26, 2026

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Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi RastogiJune 26, 2026

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LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand

Shots: LENZ has entered into an exclusive license & commercialization agreement with Arrotex to register & commercialize Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in Australia & New Zealand As per the deal, Arrotex will obtain exclusive commercialization rights for Vizz for the treatment of presbyopia in Australia & New Zealand. In return,…

ByRidhi RastogiJune 26, 2026

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Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Shots: The EC has granted ODD to ABO-101 for the treatment of primary hyperoxaluria ABO-101 is being evaluated in an open-label global P-I/II (redePHine) study assessing safety, tolerability, PK/PD, & preliminary efficacy of a single dose of ABO-101 in pts with PH type 1 ABO-101 is a one-time, liver-directed gene-editing therapy that uses an Acuitas-licensed…

ByRidhi RastogiJune 26, 2026

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Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026 Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…

ByRidhi RastogiJune 26, 2026

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CStone Pharmaceuticals Partners with Arrotex to Commercialize Sugemalimab across Australia and New Zealand

Shots: CStone Pharmaceuticals has entered into an exclusive commercialization agreement with Arrotex for the commercialization of sugemalimab in Australia & New Zealand As per the deal, Arrotex will be responsible for regulatory submissions & obtain exclusive commercialization rights for sugemalimab in Australia & New Zealand across all approved & future indications In return, CStone will…

ByRidhi RastogiJune 26, 2026

NEWS

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Shots: The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of…

ByRidhi RastogiJune 25, 2026

Ridhi Rastogi

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand

Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

CStone Pharmaceuticals Partners with Arrotex to Commercialize Sugemalimab across Australia and New Zealand

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

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