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…
NEWS
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…
Shots:
The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease
Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…

