Shots:
EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors
The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer
Preclinical data showed robust anti-tumor activity across…
NEWS
Shots:
The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year
NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…
Shots:
Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs
Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization
The collaboration…
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,…
Shots:
Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.)
Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week
Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
Shots:
Radiopharm Theranostics has reported that the final patient has been dosed in its US P-IIb imaging trial of RAD 101, evaluating recurrent brain metastases in patients with solid tumors. 1EP readout is expected in Jun’26, with plans to advance RAD 101 into a US P-III pivotal trial
The P-IIb trial is assessing 18F-RAD101 in…
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…
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…
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…
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. chronic hand eczema (CHE); regulatory review is ongoing in the EU
sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

