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PharmaShots Weekly Snapshots (March 31, 2025 – April 04, 2025)

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Weekly Snapshot

PharmaShots Weekly Snapshots (March 31, 2025 – April 04, 2025)

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

 

Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases 

Read More: Eli Lilly 

AstraZeneca Reports the Data from PURSUIT P-IIb Study Evaluating AZD0780 

Read More: AstraZeneca 

Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS) 

Read More: Axsome Therapeutics 

Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer 

Read More: Daiichi Sankyo 

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors 

Read More: BridgeBio Oncology Therapeutics 

 

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC 

Read More: BMS 

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL) 

Read More: AstraZeneca 

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer 

Read More: Genmab and Pfizer 

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B 

Read More: Alnylam Pharmaceuticals and Sanofi 

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease 

Read More: Pfizer 

Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3G and Primary IC-MPGN 

Read More: Apellis Pharmaceuticals 

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease 

Read More: Averoa 

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN) 

Read More: Novartis 

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD) 

Read More: Amgen 

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC) 

Read More: Daiichi Sankyo and AstraZeneca 

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Read More: AstraZeneca

 

Lexicon Enters a Global Licensing Agreement with Novo Nordisk for LX9851 

Read More: Lexicon and Novo Nordisk 

Ono Enters into an Option Agreement with Reborna Biosciences for RNA-Targeting Small Molecule to treat CNS Disorders 

Read More: Ono and Reborna Biosciences  

Sanofi Licenses an Undisclosed Nurix Therapeutics’ Drug Program for Autoimmune Diseases 

Read More: Sanofi and Nurix Therapeutics 

Eli Lilly Enters a ~$1.4B Licensing Agreement with Sangamo Therapeutics for its STAC-BBB Capsid 

Read More: Eli Lilly and Sangamo Therapeutics 

 

Visby Medical Reports the US FDA’s De Novo Authorization of its Women's Sexual Health Test for Over-the-Counter Use 

Read More: Visby Medical 

Echo IQ Enters into Strategic Partnership And Integration Agreements With ScImage And MedAxiom for EchoSolv AS 

Read More: Echo IQ, ScImage and MedAxiom 

The US FDA Grants 510(k) Clearance to Teleflex’s AC3 Range Intra-Aortic Balloon Pump (IABP) for Cardiac Patient Mobility 

Read More: Teleflex 

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform 

Read More: Medivis 

AVITA Medical Launches Cohealyx for Wound Healing in the US 

Read More:  AVITA Medical 

 

Siemens to Acquire Dotmatics for $5.1B, Strengthening its Position in Life Science Market 

Read More: Siemens and Dotmatics 

 

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen in the US 

Read More: Organon and Biogen 

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) 

Read More: Accord Healthcare 

  

Spirited Paw Launches Calm Chewable Wafers for Dogs and Cats 

Read More: Spirited Paw 

 

NetraMark Join Forces with Worldwide Clinical Trials to Redefine Clinical Trial Design Using NetraAI Platform 

Read More: NetraMark and Worldwide Clinical Trials 

 

Related Post: PharmaShots Weekly Snapshots (March 24, 2025 – March 28, 2025) 


Ridhi Rastogi

Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.

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