Shots:
The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening
The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…
NEWS
Shots:
Vanda Pharmaceuticals has initiated the Thetis study assessing Nereus (tradipitant) vs PBO for the prevention of vomiting in pts receiving GLP-1 receptor agonist therapies
The Thetis study will assess the proportion of pts free from vomiting episodes as the 1EP, with Vanda expecting topline results by Q4’26 & noting that additional data may be…
Shots:
Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season
Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination
Nuvaxovid…
Shots:
Dyno Therapeutics has reported that Astellas has exercised its option to license an AI-engineered AAV capsid for skeletal muscle delivery, marking the first licensed asset from their 2021 collaboration
The capsid, designed using Dyno’s AI models trained on large-scale in vivo data, demonstrates improved muscle targeting at lower doses, addressing key safety & manufacturing…
Shots:
Garda Therapeutics has entered into a definitive agreement to acquire Assertio, delisting it from Nasdaq
As per the deal, Garda will acquire Assertio for $18/share in cash (~$125.1M) plus a non-tradeable CVR related to potential future milestones for Sprix, with the deal expected to close in Q2’26 & remaining shares acquired later via a…
Shots:
The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs
ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…
Shots:
Halozyme Therapeutics, via its subsidiary Halozyme Hypercon, has entered a global exclusive collaboration & license agreement with Vertex to utilize its Hypercon technology across up to three drug targets
As per the deal, Halozyme will receive $15M upfront, with additional milestone payments & royalties tied to products developed using the technology
Hypercon is a…
Shots:
The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC
NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…
Shots:
The NMPA has approved Exdensur as an add-on therapy for adults with CRSwNP for whom therapy with systemic corticosteroids & /or surgery do not provide adequate disease control, based on P-III (ANCHOR 1 & 2) trials
The ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…
Shots:
Biocon has reported the commercial launch of Bosaya & Aukelso, an interchangeable biosimilar version of Prolia & Xgeva (Denosumab) in the US, following FDA approval in Sep 2025
Bosaya will be available in the 60mg/mL PFS format, while Aukelso will be available as 120mg/1.7 mL (70mg/mL) single-dose vial, both for subcutaneous use
Denosumab is a…

