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

The CHMP Grants BMS’ with Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma 

Read More: BMS                                                                  

GSK’s Omjjara (momelotinib) Receives the European Commission Approval for the Treatment of Severe Anaemia 

Read More: GSK                                                                      

The Pharmacy and Poisons Board of Hong Kong Approves HUTCHMED’s Elunate (fruquintinib) for Metastatic Colorectal Cancer (CRC)

Read More HUTCHMED                                                                        

The US FDA Approves Takeda’s GAMMAGARD LIQUID to Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Read More Takeda                                                                                                                              

The US FDA Accepts AstraZeneca and Daiichi Sankyo’s sBLA for Enhertu and Grants Priority Review for the Treatment of HER2-Expressing Solid Tumors 

Read More AstraZeneca & Daiichi Sankyo                                                                                       

The US FDA Grants IND Clearance to Gracell Biotechnologies’s GC012F to Treat Multiple Myeloma

Read More Gracell Biotechnologies                                                               

Daiichi Sankyo Submits sNDA to the Japan MHLW for Ezharmia as a Treatment of Peripheral T-Cell Lymphoma (PTCL) 

Read More Daiichi Sankyo                                                               

Astellas Submits sNDA for Padcev in Combination with Keytruda to the Japan MHLW for the Treatment of Advanced Bladder Cancer 

Read More Astellas                                               

The US FDA and Japan MHLW Accept BMS’ sBLA for Breyanzi to Treat Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)

Read More BMS                                                                                                                             

USGI Medical’s POSE2.0 Incisionless Weight Loss Procedure Receives US FDA’s IDE Approval for Primary Obesity

Read More USGI Medical                                                                                           

SeaStar Medical’s Selective Cytopheretic Device Technology Obtains Canadian Patent 

Read More SeaStar Medical                                                         

Merck Highlights the P-III Trial Data for Keytruda (Pembrolizumab) as an Adjuvant Therapy for Urothelial Carcinoma

Read More: Merck                                                                

Vertex Highlights Results from Two P-III Analysis of VX-548 for the Treatment of Moderate-to-Severe Acute Pain

Read More Vertex                                                                 

Genentech Presents Results from P-III (BALATON and COMINO) Studies of Vabysmo for Macular Edema

Read More Genentech                                                         

Sensorion Completes Patient Recruitment in the P-IIa Study of SENS-401 for Residual Hearing Preservation After Cochlear Implantation

Read More Sensorion                                                                                

Sirius Therapeutics Initiates P-I Trial of SRSD107 for Treating Thromboembolic Disorders

Read More Sirius Therapeutics                     

Qilu Pharmaceutical Publishes Results from the P-II Trial of QL1706 for Non-Small Cell Lung Cancer (NSCLC) in Signal Transduction and Targeted Therapy            

Read More Qilu Pharmaceutical                                                        

Glenmark Signs a Collaboration Agreement with Jiangsu and 3D Medicines to Develop Envafolimab (KN035) for the Treatment of Cancer Indications 

Read More: Glenmark                                                                                                            

Synthekine Signs a Collaboration Agreement with Sanofi to Develop Selective IL-10 Agonists for the Treatment of Inflammatory Diseases

Read More: Synthekine & Sanofi                                                                                                      

Agilent and Incyte Sign a Collaboration Agreement to Advance the Development of Companion Diagnostics

Read More Agilent & Incyte                                                                            

Abbott Introduces Protality to Help Adults Lose Weight

Read More Abbott                                                                                           

Kiora Pharmaceuticals and Théa Open Innovation Have Collaborated to Develop and Commercialize KIO-301 for Retinal Diseases

Read More Kiora Pharmaceuticals & Théa Open Innovation                            

Inmagene Biopharmaceuticals to License HUTCHMED’s IMG-007 and IMG-004 Under the Agreement 

Read More HUTCHMED & Inmagene Biopharmaceuticals                   

Ceva Santé to Acquire Scout Bio

Read More: Ceva Santé & Scout Bio                                                                                                      

Merck Animal Health Introduces Allflex CleanVax Nozzles and Shields for Intranasal Vaccine Administration in Cattle

Read More Merck Animal Health                                                                       

Orion Enters into a Collaborative Agreement with Newel Health to Develop ODD-403 for Chronic Pain

Read More: Orion & Newel Health                                                                             

The US FDA Grants 510(k) Clearance to Copan Diagnostics’ Colibrí to Expand Automated ID/AST Capabilities

Read More: Copan Diagnostics                                                            

NuvoAir’s Air Next Spirometer Receives the US FDA’s 510(k) Clearance for In-Home Use

Read More NuvoAir                                                                                     

Boston Scientific’s Farapulse Pulsed Field Ablation System Receives the US FDA’s Approval for Atrial Fibrillation

Read More Boston Scientific                                                               

The US FDA Clears Hologic’s Genius Digital Diagnostics System to Identify Pre-Cancerous Lesions

Read More Hologic