PharmaShots Weekly Snapshots (February 19 – February 23, 2024)

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


The US FDA Approves Roche’s Xolair for Food Allergies

Read More: Roche                                                                               

The US FDA Approves AstraZeneca’s Tagrisso, in Combination with Chemotherapy, for Treating EGFRm Advanced NSCLC

Read More: AstraZeneca                                                                  

Iovance Receives the US FDA’s Accelerated Approval for Amtagvi (lifileucel) as a Treatment for Metastatic Melanoma (MM)

Read More: Iovance                                                                            

The US FDA’s Accepts Daiichi Sankyo and AstraZeneca’s BLA for Datopotamab Deruxtecan to Treat Non-Small Cell Lung Cancer

Read More: Daiichi Sankyo & AstraZeneca                                          

The European Commission Approves Pfizer’s Velsipity (etrasimod) for the Treatment of Severely Active Ulcerative Colitis

Read More: Pfizer                                                                            

The US FDA Accepts and Grants Priority Review to argenx’s sBLA of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Read More: argenx                                                                           

The US FDA Grants FTD to Certa Therapeutics’ FT011 for the Treatment of Systemic Sclerosis 

Read More: Certa Therapeutics                                                       

The US FDA Accepts and Grants Priority Review to Merck’s sBLA for Keytruda Plus Chemotherapy to Treat Endometrial Carcinoma

Read More: Merck                                                                            

The US FDA Accepts and Grants Priority Review to BMS’ sNDA for Krazati & Cetuximab Combination to Treat Colorectal Cancer (CRC)

Read More: BMS                                                                        

RAPT Therapeutics Reports the US FDA’s Clinical Hold on the Studies Investigating Zelnecirnon

Read More: RAPT Therapeutics                                                   

The US FDA Approves Mabwell’s IND Application for 7MW3711 as a Treatment for Solid Tumors

Read More: Mabwell                                                                   

The US FDA Approves Johnson & Johnson’s sBLA of Tecvayli for Treating Relapsed/Refractory Multiple Myeloma

Read More: Johnson & Johnson                                                               

The US FDA Accepts and Grants Priority Review to Sanofi’s sBLA of Dupixent for the Treatment of COPD with Type 2 Inflammation

Read More: Sanofi                                                                            

The US FDA Grants FTD to Artiva Biotherapeutics’ AlloNK (AB-101) for the Treatment of Lupus Nephritis

Read More: Artiva Biotherapeutics                                                            

The CHMP Grants Positive Opinion toCSL Vifor and Travere Therapeutics’ Sparsentan for the Treatment of IgA Nephropathy

Read More: Artiva Biotherapeutics               


Almirall and Novo Nordisk Collaborate to Develop NN-8828 for Treating Dermatological Diseases

Read More: Almirall & Novo Nordisk                                           

Immune-Onc Therapeutics and Roche Partner to Assess IO-108 for the Treatment of Advanced Hepatocellular Carcinoma

Read More: Immune-Onc Therapeutics and Roche                       

Biocytogen and Gilead have Signed a Multi-Target Antibody Collaboration Agreement to Select and Develop Therapeutic Targets for the Treatment of Multiple Disease

Read More: Biocytogen & Gilead                                                     

Mainz Biomed Collaborates with TomaLab for Enhancing the Diagnosis of Colorectal Cancer Using ColoAlert 

Read More: Mainz Biomed & TomaLab                                                     

Immunocore and BMS Collaborate for the Development of IMC-F106C in the P-III Trial for the Treatment of Melanoma

Read More: Immunocore & BMS                                                       

AbbVie and Tentarix Biotherapeutics Collaborate to Develop Biologics for Oncology and Immunology

Read More: AbbVie & Tentarix                                                     


Boehringer Ingelheim Collaborates with Sleip AI to Utilize AI-technology for Detecting Lameness in Horse

Read More: Boehringer Ingelheim & Sleip AI                              

Ono Pharmaceutical and InveniAI Sign a Research Collaboration Agreement for the Identification of Novel Therapeutic Targets Using AI and ML

Read More: Ono Pharmaceutical & InveniAI             


Innovent Highlights the P-III (RESTORE-1) Trial Results of IBI311 to Treat Thyroid Eye Disease (TED) 

Read More: Innovent                                                                    

ViiV Healthcare (GSK & Pfizer’s Global Specialist HIV Company) Highlights P-III (LATITUDE) Trial Results of Cabenuva (cabotegravir + rilpivirine) for HIV 

Read More: ViiV Healthcare                                                   

Aleta Biotherapeutics Doses First Patient with ALETA-001 in P-I/II Trial for the Treatment of R/R B-Cell Malignancies

Read More: Aleta Biotherapeutics                                                      

CymaBay Publishes P-III Results for Seladelpar as a Treatment of Primary Biliary Cholangitis in the New England Journal of Medicine 

Read More: CymaBay                                                                     

SynAct Pharma Highlights Further Analysis from the P-IIb (EXPAND) Study Supporting the Development of Resomelagonin for Rheumatoid Arthritis

Read More: SynAct Pharma                                                                        


Mabwell Publishes the P-III Study Results of MW032 (Biosimilar, Denosumab) for Solid Tumors in JAMA Oncology

Read More: Mabwell