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Sanofi & J&J
News

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots: Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…
February 14, 2025

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Pfizer & Astellas
News

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Shots: Pfizer & Astellas have reported follow-up data from P-III (KEYNOTE-A39/EV-302) trial assessing Padcev + Keytruda vs Pt-based CT in previously untreated la/mUCpts (n=886) The 12mos. follow up study (mFU: 29.1mos.) showed reduced risk of death by 49% & decrease in PFS by 52% (mPFS: 12.5 vs 6.3mos.) with improved mOS (33.8 vs 15.9mos.), where OS…
February 12, 2025

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Boehringer Ingelheim
News

Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)

Shots: BI reported topline data from P-III (FIBRONEER-ILD) study assessing nerandomilast (BI 1015550; 9/18mg, BID) vs PBO in PPF pts (n=1178) for ~52wks. with regulatory filings in the US & other regions underway Study met its 1EP of absolute change from baseline in forced vital capacity (FVC; mL) with favorable safety consistent with P-II; full…
February 11, 2025

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Akesobio
News

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

Shots: Akeso has completed patient enrollment in the global P-III (HARMONi-6/AK112-306) trial (1/6 P-III trials) assessing ivonescimab + Pt-based CT vs Tevimbra + Pt-based CT to treat 1L squamous NSCLC in China Multiple P-III trials are underway, incl. HARMONi-3 (vs Keytruda + CT) in 1L sq- & non-sq NSCLC (led by Summit Therapeutics), plus trials…
February 6, 2025

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Viewpoints_Dale Curtis Jr
VIEWPOINTS

Intelligent Automation and Beyond: Dale Curtis Jr from Astrix in an Enlightening Conversation with PharmaShots

Shots:  The biopharma industry faces several challenges, including digital transformation, regulatory compliance, and managing large volumes of data  Intelligent automation plays a vital role in drug discovery, clinical trials, manufacturing, and commercialization, helping optimize operations and better meet customer needs  Astrix CEO Dale Curtis Jr. discusses the role of AI and machine learning in global…
January 31, 2025

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ITM
News

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The P-III (COMPETE) trial assessed ITM-11 (7.5 GBq + nephroprotective amino acid, Q3M × max. 4 cycles) vs everolimus (10mg for ~30mos. or until disease progression) in patients (n=309) with inoperable, progressive, SSTR+ gr 1/2 GEP-NETs. The US FDA’s NDA submission is expected in 2025 The study met its 1EP of improved PFS,…
January 29, 2025

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News

Lisata Therapeutics and WARPNINE Reports Initial Results from P-Ib/IIa (iLSTA) trial of Certepetide Regimen in Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: P-Ib/IIa (iLSTA) trial assessed certepetide (LSTA1; iRGD cyclic peptide) ± SoC CT ± Imfinzi in LA inoperable PDAC pts (N=30) randomized into 3 arms, with A1 (n=5) receiving SoC CT + PBO Imfinzi & PBO certepetide; A2 (n=5) receiving SoC CT + certepetide & PBO Imfinzi; A3 (n=20) receiving SoC CT + Imfinzi &…
January 24, 2025

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