NEWS

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)…

23 hours ago

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…

24 hours ago

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,…

1 day ago

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…

1 day ago

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…

1 day ago

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…

1 day ago

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…

2 days ago

Merck KGaA to Acquire Bio-Techne for ~$11.3B

Shots: Merck KGaA has entered into a definitive agreement to acquire Bio-Techne, bringing together two companies with complementary portfolios spanning research tools, diagnostics, bioprocessing, and advanced therapeutics As per the deal, Merck KGaA will acquire Bio-Techne for $73/share in cash, representing a total enterprise value of ~$11.3B; closing is expected by late 2026 or early…

2 days ago

Ionis Inks ex-US Deal with Recordati for Zilganersen in Alexander Disease

Shots: Ionis has granted Recordati exclusive rights to develop & commercialize zilganersen for Alexander disease outside the US, while Ionis retains US commercialization rights & will continue to lead global development Ionis will receive $30M upfront & additional milestone payments, with tiered royalties of up to the mid-20% range on annual net sales. Recordati will…

2 days ago

Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

Shots: Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the…

2 days ago

NEWS

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

Merck KGaA to Acquire Bio-Techne for ~$11.3B

Ionis Inks ex-US Deal with Recordati for Zilganersen in Alexander Disease

Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

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