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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test
Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…
May 27, 2026
Eli Lilly Builds Infectious Disease Pipeline With 3 Acquisitions Valued ~$3.8B
Shots: Eli Lilly will acquire 3 companies, Curevo, LimmaTech Biologics, & Vaccine Company, to build its infectious disease portfolio through differentiated vaccine & platform technologies The deals incl. Curevo’s P-II shingles vaccine candidate amezosvatein, LimmaTech’s P-I vaccine LTB-SA7 targeting S. aureus infections, & Vaccine Company’s preclinical EBV vaccine platform leveraging proprietary in vivo nanoparticle technology As…
May 26, 2026
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…
May 26, 2026
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…
May 26, 2026
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…
May 26, 2026
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…
May 26, 2026
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…
May 25, 2026
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…
May 25, 2026
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