PharmaShots Weekly Snapshots (December 04 – December 08, 2023)

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PharmaShots Weekly Snapshots (December 04 – December 08, 2023)

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

The NMPA Approves Everest Medicine's IND Application for Zetomipzomib

Read More: Everest Medicine                                                                     

The TGA Accepts Shanghai Junshi’s Toripalimab for Treatment of Nasopharyngeal Carcinoma

Read More: Shanghai Junshi                                                                     

The US FDA Approves Eli Lilly’s Jaypirca for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Read More: Eli Lilly                                                                                   

The US FDA Accepts BMS’s sBLA for Opdivo-Based Combination Therapy for Priority Review to Treat Urothelial Cancer

Read More: BMS                                                                                 

The US FDA has granted FTD and BTD to CG Oncology’s Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Read More: CG Oncology                                                                                

The US FDA has Granted Approval to Novartis’ Fabhalta (iptacopan) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

Read More: Novartis                                                                                

BMS' Abecma has Obtained sNDA Approval in Japan for Early Lines of Therapy in R/R Multiple Myeloma (RRMM)

Read More: BMS                                                                                          

Sosei Group Secures MFDA’s Marketing Approval of Pivlaz (clazosentan sodium) for Aneurysmal Subarachnoid Hemorrhage (aSAH)

Read More: Sosei                                                                                    

Roche Announces the Acquisition of Carmot Therapeutics ~$3.1B

Read More: Roche                                                                                     

For About $8.7B, AbbVie to Acquire Cerevel Therapeutics

Read More: AbbVie & Cerevel Therapeutics                                             

Vanda Pharmaceuticals Sings an Agreement with Janssen to Acquire the US and Canadian Rights for Ponvory from Janssen to Treat Relapsing Multiple Sclerosis 

Read More: Vanda Pharmaceuticals, Janssen & Actelion                     

Nona Biosciences entered into collaboration with Lycia Therapeutics to develop Protein Degradation Technology

Read More: Nona Biosciences                                                                   

Palvella Therapeutics and Ligand Pharmaceuticals are Expanding their Strategic Partnership to Expedite the P-III Development Of Qtorin Rapamycin 

Read More: Palvella Therapeutics & Ligand Pharmaceuticals              

Absci and AstraZeneca Sign a Collaboration Agreement to Discover AI-Driven Cancer Treatment

Read More: Absci & AstraZeneca                                                         

AQEMIA and Sanofi have Signed Multi-year Collaboration of $140M

Read More: AQEMIA & Sanofi                                                                     

AbbVie Sings a Collaboration Agreement with BigHat Biosciences to Discover and Develop Therapeutic Antibodies

Read More: AbbVie & BigHat Biosciences                                          

Innovent Biologics Expands its Licensing Agreement with Synaffix for the Development of Antibody Drug Conjugates (ADCs) 

Read More: Innovent Biologics & Synaffix                                           

The US FDA Renews Conditional Approval for Jaguar Health's Canalevia-CA1 for Chemotherapy-Induced Diarrhea in Dogs

Read More: Jaguar Health                                                                      

Gallant Therapeutics is Set to Initiate the JEDI Study to Evaluate Allogeneic Stem Cell Therapy for Feline Chronic Gingivostomatitis (FCGS) in Cats

Read More: Gallant Therapeutics                                                             

GE HealthCare and AirStrip are going to Integrate their Expertise for Patient Monitoring and Cardiac Data Visualization

Read More: GE HealthCare & AirStrip                                                         

Clinical Trial

The US FDA Approves Tonix Pharmaceuticals’ IND Application for TNX-2900 to Treat Prader-Willi Syndrome

Read More: Tonix Pharmaceuticals                                                             

Genentech Highlights P-III Results for Inavolisib Combination Therapy to Treat Breast Cancer

Read More: Genentech                                                                        

Merck KGaA Highlights the P-III Results for Evobrutinib to Treat of Relapsing Multiple Sclerosis (RMS)

Read More: Merck KGaA                                                                 

Sanofi Highlights the P-III Trial Results for Sarclisa (Isatuximab) to Treat Newly Diagnosed Multiple Myeloma Patients

Read More: Sanofi                                                                                  

Merck will Discontinue its P-III (KEYLYNK-008) Study of Keytruda (pembrolizumab) + Lynparza (olaparib) for Metastatic Squamous NSCLC

Read More: Merck                                                                                

The First Atopic Dermatitis Patient was Dosed with KT-474 in the P-II Trial Conducted by Sanofi Under its Collaboration with Kymera Therapeutics

Read More: Kymera Therapeutics & Sanofi                                          

BMS' P-III (CheckMate -8HW) Study Evaluating Opdivo + Yervoy for MSI-H/dMMR mCRC has Achieved its Primary Endpoint 

Read More: BMS                                                                                  

The US FDA Granted 510(k) Clearance to Exactech’s Surgical Navigation System ExactechGPS Ankle for Total Ankle Replacement 

Read More: Exactech                                                                    

The US FDA Approves Mallinckrodt’s INOmax EVOLVE DS Delivery System to Deliver Nitric Oxide Gas in Newborns with Pulmonary Hypertension

Read More: Mallinckrodt                                                                          

The US FDA has approved Bio-Thera’s Avzivi (Biosimilar, Avastin)

Read More: Bio Thera                                 

Related News:- PharmaShots Weekly Snapshots (November 27 – December 1, 2023)                        

Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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