PharmaShots Weekly Snapshots (March 04 – March 08, 2024)

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

Cullinan Oncology Reports the US FDA’s IND Clearance of CLN-619 for the Treatment of R/R Multiple Myeloma

Read More: Cullinan                                                          

The US FDA Approves Johnson & Johnson’s Rybrevant in Combination with Chemotherapy as a 1L Treatment of NSCLC with EGFR Exon 20 Insertion Mutations

Read More: Johnson & Johnson                                              

The EMA Validates two MAAs of AstraZeneca & Daiichi Sankyo’s Datopotamab Deruxtecan to Treat NSCLC and Breast Cancer

Read More: AstraZeneca & Daiichi Sankyo                                 

The EMA Accepts for Review CymaBay’s MAA for Seladelpar to Treat Primary Biliary Cholangitis

Read More: CymaBay                                                                 

The NMPA Accepts Innovent and AnHeart Therapeutics’ Second NDA for Taletrectinib to Treat Lung Cancer

Read More: Innovent & AnHeart Therapeutics                                

The EMA Validates Madrigal Pharmaceuticals’ MAA of Resmetirom for the Treatment of NASH/MASH with Liver Fibrosis 

Read More: Madrigal Pharmaceuticals                                                    

Johnson & Johnson Submits Type II Variation Application to the EMA for Darzalex as a Treatment of Multiple Myeloma

Read More: Johnson & Johnson                                                           

The US FDA Approves Formosa Pharmaceuticals’ Clobetasol Propionate for Treating Post-Operative Inflammation and Pain Following Ocular Surgery

Read More: Formosa Pharmaceuticals                                                  

MindMed Receives the US FDA’s BTD for MM120 and Reports the P-IIb Trial Results for the Treatment of Generalized Anxiety Disorder (GAD)

Read More: MindMed                                                                          

The US FDA Grants Accelerated Approval to BeiGene’s Brukinsa for the Treatment of Follicular Lymphoma (FL)

Read More: BeiGene

The US FDA Grants Approval to BMS’ Opdivo (nivolumab) in Combination with Cisplatin and Gemcitabine for the Treatment of Urothelial Carcinoma (UC)

Read More: BMS


Astellas Begins the P-III Study to Investigate Fezolinetant for the Treatment of VMS Associated with Menopause in Japan

Read More: Astellas

Novartis Reports Updated Results from the P-IIIb (SMART) Trial of Zolgensma for Treating Spinal Muscular Atrophy (SMA)

Read More: Novartis

Roche and Alnylam Report Data from the P-II (KARDIA-2) Study Evaluating Zilebesiran for the Treatment of Hypertension

Read More: Roche & Alnylam

CASI Pharmaceuticals and BioInvent Reports P-I Trial Results of BI-1206 to Treat Non-Hodgkin’s Lymphoma in China

Read More: CASI Pharmaceuticals & BioInvent 

Abbott Highlights Data from the Real-World Studies of Freestyle Libre Systems and GLP-1 Medicines for Type 2 Diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2024

Read More: Abbott

Gilead and Merck Highlight Data from the P-II Study Investigating the Combination of Islatravir & Lenacapavir for HIV

Read More: Gilead and Merck

GSK Reports Data from the P-III (DREAMM-8) Trial Evaluating Blenrep for the Treatment of R/R Multiple Myeloma (RRMM)

Read More: GSK

Tonix Pharmaceuticals Publishes Results of TNX-102 SL in P-III Trial for Military-Related PTSD in Psychiatry Research

Read More: Tonix Pharmaceuticals 


The US FDA Approves Boston Scientific’s AGENT Drug-Coated Balloon for the Treatment of Coronary In-Stent Restenosis (ISR) 

Read More: Boston Scientific 

The US FDA Grants BDD to Quanterix’s Simoa P-Tau 217 Blood Test for the Diagnosis of Alzheimer’s Disease

Read More: Quanterix


Bayer and BridgeBio Join Forces to Commercialize Acoramidis for the Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in Europe

Read More: Bayer & BridgeBio 

C4 Therapeutics and Merck KGaA Enter into a License & Collaboration Agreement to Discover Protein Degraders Against Oncogenic Proteins

Read More: C4 Therapeutics & Merck KGaA

Sonata Therapeutics Collaborates with the Champalimaud Foundation for the Development of SNT-3012 to Treat Pancreatic and Colorectal Cancers

Read More: Sonata Therapeutics 

Merus and Gilead Partner for the Discovery of Antibody-Based Trispecific T-Cell Engagers

Read More: Merus & Gilead

Kyverna Therapeutics Signs a Collaboration Agreement with Stanford University to Evaluate KYV-101 for Multiple Sclerosis

Read More: Kyverna Therapeutics

Solid Biosciences Enters into an Exclusive License Agreement with Armatus Bio for AAV-SLB101 in Facioscapulohumeral Muscular Dystrophy (FSHD)

Read More: Solid Biosciences & Armatus Bio


Telix Acquires ARTMS along with its Advanced Isotope Production Platform

Read More: Telix & ARTMS

Peak Bio and Akari Therapeutics have Entered into a Merger Agreement to Form an Expanded Pipeline of Novel Antibody Drug Conjugate (ADC) 

Read More: Peak Bio & Akari Therapeutics


The US FDA Approves Sandoz’ Wyost and Jubbonti, Biosimilar Versions of Xgeva and Prolia (denosumab)

Read More: Sandoz

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