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

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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

Related Post: PharmaShots Weekly Snapshots (February 26 – March 01, 2024)

Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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