PharmaShots

Shots: Eli Lilly reported positive topline results from the P-III (ACHIEVE-4) study of Foundayo (orforglipron) vs insulin glargine in ~2,700 pts with type 2 diabetes, and obesity or overweight with elevated CV risk, meeting the 1EP of non-inferiority in MACE-4 events Foundayo demonstrated a 16% lower risk of MACE-4 and 23% lower risk of MACE-3, with a 57% reduction in all-cause mortality (HR=0.43), alongside superior reductions in A1C (-1.6% vs -1.0%) and body weight (-8.8% vs +1.7%) at 52wks.

Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous acquisition of spectral and conventional imaging in a single scan, supporting...

Shots: Aligos has entered into an exclusive license agreement with Xiamen Amoytop Biotech, granting Amoytop rights to develop & commercialize pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection As per the deal, Aligos will receive an $25M upfront & ~$420M in clinical, regulatory, & sales milestones along with tiered, high single-digit royalties, while retaining rights in the US, EU, South Korea, Japan, & all other markets.

Shots: Interna has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute Boston to evaluate its MNM technology as a delivery enhancer for targeted therapeutic modalities As per the deal, the companies will integrate MNM molecules with targeting approaches to enhance intracellular delivery & therapeutic performance, initially focusing on preclinical studies with potential expansion to broader research activities & additional programs; financial...

Shots: The US FDA has accepted LEO Pharma‘s sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev.

Shots: CareDx has entered a definitive agreement to divest its Lab Products business, incl. PCR & NGS-based transplant diagnostics, to EuroBio Scientific for $170M in cash Divestiture aims to streamline operations and refocus on core Precision Medicine Testing Services and digital solutions, while retaining exclusive North America rights to distribute post-transplant monitoring IVD tests, incl.

Shots: The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson’s disease (PD) The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl.

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk is an IV, ultra-short-acting selective beta-1 blocker used in monitored hospital settings, with rapid onset & offset...

Shots: Health Canada has approved ARS Pharma‘s neffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in adults & children (>30kg) In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl.

Shots: The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables TOBY to expand adoption of accessible early cancer detection solutions Ref:...