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Merck
News

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Shots:Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…
February 7, 20250Comments

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News

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Shots:The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25 Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…
February 7, 20250Comments

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News

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots:The US FDA has granted FTD to ADI-001 for treating  adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…
February 6, 20250Comments

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ThoughtSpot_Carla Adams
THOUGHTSPOT

How Pharma and Social Work Can Collaborate on Chronic Disease Management

Chronic diseases like diabetes, heart disease, and hypertension are among the leading causes of death worldwide. These conditions affect millions of people, placing a significant strain on individuals, families, and healthcare systems. While pharmaceutical advancements have revolutionized treatment options, they cannot address every aspect of a patient’s journey. To tackle the complex challenges of chronic disease…
February 6, 20250Comments

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Astrazeneca
News

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…
February 6, 20250Comments

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Gradalis
News

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots:The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…
February 6, 20250Comments

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Imagene & Tempus
News

Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC

Shots:Imagene & Tempus AI have collaborated to advance lung cancer diagnostics by enhancing biomarker prediction, integrating AI tools into clinical workflows, & allowing commercial access to diagnostic solutions Collaboration will integrate Imagene's AI multi-gene panel for rapid NSCLC biomarker prediction from biopsy images with Tempus' clinical reach & real-world data, creating a unified…
February 6, 20250Comments

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