Shots:
GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012
As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
Shots:
Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights
As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones
XH-S004 (DPP-1 inhibitor, PO) is being investigated…
Shots:
GSK will obtain an exclusive global license to HRS-9821, an add-on maintenance therapy for COPD, along with exclusive option rights to develop & commercialize ~11 more programs in oncology, respiratory, immunology, & inflammation globally (excl. mainland China, Hong Kong, Macau, & Taiwan for both)
Each of the ~11 additional programs will have its own…
Shots:
Merck has entered into a definitive agreement to acquire Verona Pharma incl. its asset Ohtuvayre (ensifentrine), expanding its cardio-pulmonary pipeline & portfolio
As per the deal, Merck will acquire Verona Pharma for $107 per American Depository Share (ADS), each representing 8 ordinary Verona shares, for an aggregate of ~$10B; closing expected in Q4'25
Ohtuvayre…
Shots:
P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies
AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
Shots:
Viz.ai has entered into a multi-year collaboration with Sanofi & Regeneron to deploy and evaluate its AI-powered chronic obstructive pulmonary disease (COPD) workflow solution
Sanofi, Regeneron, and Viz.ai collaborated on an AI-powered solution to improve care for high-risk COPD pts, focusing on how the Viz COPD module can enhance EHR workflows, access to care,…
Shots:
The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions
Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…
Shots:
Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD
The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels
Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…
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The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same
Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function…
Shots
While sharing the details on Fasenra, Andrew highlights the unmet medical need in the healthcare sector as there’s only one approved treatment for EGPA
With mepolizumab as the comparator drug for the trial, Andrew shares the positive results in achieving remission rates. Andrew sheds light on the unique mechanism of benralizumab that directly targets…

