This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below: 

Amgen Reports P-III (DeLLphi-304) Trial Findings of Imdelltra for SCLC

Read More: Amgen  

Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Read More: Pfizer

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Read More: BriaCell

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Read More: Telix Pharmaceuticals

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Read More: Eli Lilly

Endevica Bio Reports the First Patient Dosing in P-II Study Evaluating TCMCB07 (B07)

Read More: Endevica Bio

The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

Read More: BMS

Roche's Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Read More: Roche

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Read More: Eisai, Biogen and BioArctic

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Read More: InnoCare Pharma

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Read More: Neurelis

The US FDA Accepts sBLA Priority Review for Regeneron's EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Read More: Regeneron

China’s NMPA Approves Akeso's Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque

Read More: Akeso

Astellas Collaborates with Chromatin Bioscience to Develop Cell-Selective Synthetic Promoters

Read More: Astellas and Chromatin Bioscience

Cue Biopharma Collaborates with Boehringer Ingelheim to Develop B cell-Targeting Bispecifics for Autoimmune and Inflammatory Diseases

Read More: Cue Biopharma and Boehringer Ingelheim

Merck Signs a ~$493M Deal with Cyprumed to Develop Oral Peptide Therapeutics

Read More: Merck and Cyprumed

Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Read More: Oak Hill Bio and Roche

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Read More: Sanofi and Earendil Labs

Hikma Pharmaceuticals Acquires Novugen's US FDA ANDA Approved Trametinib

Read More: Hikma and Novugen

BigHat Biosciences Collaborates with Eli Lilly to Advance AI-Driven Antibody Therapeutics

Read More: BigHat Biosciences and Eli Lilly

Innoblative Secures the US FDA’s IDE Approval of SIRA Electrosurgical Device for Breast Cancer Patients

Read more: Innoblative

Bruno Vision Care’s Deseyne Contact Lens Secures the US FDA’s Approval for Dry Eye Disease

Read More: Bruno Vision Care

The US FDA Grants Conditional Approval to Initiate Second Cohort of the EFS Study of CARMAT’s Aeson Artificial Heart

Read More: CARMAT

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Read More: Ceribell

Intas Pharmaceuticals Acquires Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)

Read More: Intas Pharmaceuticals and Coherus BioSciences

RadNet to Acquire iCAD for ~$103M

Read More: RadNet and iCAD

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Read More: Celltrion

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Read More: Biocon Biologics and Regeneron

The US FDA Approves Zoetis’ Simparica Trio to Prevent Flea Tapeworm Infections in Dogs

Read More: Zoetis

Vivani Medical & Okava Pharmaceuticals Extend Collaboration to Develop OKV-119 for Canine Cardiometabolic Diseases

Read More: Vivani Medical & Okava Pharmaceuticals

Related Post: PharmaShots Weekly Snapshots (April 07, 2025 – April 11, 2025)