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Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

Shots: Merz has granted Kvvit exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, & Macao for intermittent treatment of OFF episodes in adults with Parkinson’s disease receiving levodopa/dopa-decarboxylase inhibitor Merz will supply Inbrija, oversee global quality & key regulatory activities, & act as Overseas Holder of the Drug Registration Certificate, while…

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Olympus to Acquire BioProtect for ~$270M

Shots: Olympus has entered into a definitive agreement to acquire BioProtect, incl. its Balloon Spacer system designed to protect healthy tissue during prostate cancer radiotherapy As per the agreement, Olympus will acquire BioProtect in a deal valued at ~$270M, with certain amounts held in escrow subject to uninterrupted business operations; closing is expected by the…

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Oticon Medical Launches Ponto Instant Portfolio to Expand Non-Surgical Bone Conduction Hearing Options

Shots: Oticon Medical has launched Ponto Instant, a non-surgical bone conduction hearing portfolio, adding Instant HearBand & Instant SoundConnector to expand wearable options for children & adults Instant HearBand is a lightweight behind-the-head wearable alternative to Softband 5 with customizable sizing, while Instant SoundConnector attaches sound processors to headwears, offering an additional option for lifestyle…

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Eli lilly

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

Shots: Trial assessed Lilly's VERVE-102 (IV; 0.3, 0.45, 0.6, 0.7, 0.8 & 1mg/kg) in 35 adults with HeFH or premature coronary artery disease who required additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapy Single infusion of VERVE-102 led to dose-dependent PCSK9 reductions of 51% (0.3mg/kg) to 88% (1mg/kg), with corresponding mean LDL-C reductions of…

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OSE Immunotherapeutics Reports P-II (TEDOVA) Trial Data on Tedopi Combination in Recurrent Ovarian Cancer

Shots: OSE Immunotherapeutics has reported the topline P-II (TEDOVA/GINECO-OV244b/ENGOT-ov58) trial results evaluating Tedopi (OSE2101) ± Keytruda as a maintenance treatment in pts with Pt-sensitive recurrent ovarian cancer (PSOC)  Trial enrolled 185 pts with PSOC who progressed after or were ineligible for PARP inhibitors & Avastin. Pts achieving CR, PR, or stable disease after Pt-based therapy…

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Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Shots: The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively Pyrukynd will be…

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Pharming Reports the EC approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

Shots: The EC has approved Joenja for pts (≥12yrs.) with APDS syndrome across all 30 EEA states. Initial launch is expected in Germany in Q3’26, with further launches anticipated subject to completion of national reimbursement negotiations Approval was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12yrs.), showing significant improvement in…

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Astrazeneca & Daiichi Sankyo

Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The US FDA has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease…

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