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PharmaShots Weekly Snapshots (July 22 – July 26, 2024)

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PharmaShots Weekly Snapshots (July 22 – July 26, 2024)

This week PharmaShots’ news was all about the updates on Clinical Trials, Pharma, Biotech, COVID-19, Regulatory & MedTech. Check out our full report below:

              

Innovent Reports Data from the P-III (DREAMS-1) Study of Mazdutide to Treat Type 2 Diabetes in Chinese Patients

Read More: Innovent                                                                                                 

EDAP Reports Interim Data from P-III Trial of Robotic HIFU for Treating Deep Infiltrating Endometriosis

Read More: EDAP                                                                                                     

Cytoki Pharma Reports Results from the P-I Study of CK-0045 to Improve Cardiometabolic Risk Factors

Read More: Cytoki Pharma                                                                                       

Merck Reports the P-IIb/III Study Data of Clesrovimab (MK-1654) to Prevent RSV Disease in Infants

Read More: Merck                                                                                                     

Pfizer Reports Topline Data from P-III Trial of Giroctocogene Fitelparvovec for Treating Hemophilia A

Read More: Pfizer                                                                                                   

Calliditas Reports Results from P-IIb (TRANSFORM) Study of Setanaxib for Treating Primary Biliary Cholangitis

Read More: Calliditas                                                                                                  

 

Certa Therapeutics’ FT011 Gains the EMA’s Orphan Drug Designation to Treat Systemic Sclerosis

Read More: Certa Therapeutics                                                                                  

Zymeworks Reports the US FDA’s IND Clearance of ZW191 for Treating Solid Tumors

Read More: Zymeworks                                                                                              

Johnson & Johnson Reports sNDA Submission of Spravato to the US FDA for Treatment-Resistant Depression

Read More: Johnson & Johnson                                                                                 

The USPTO Issues Patent Covering Precision Biologics’ NEO-201 for its Methods of Targeting Treg Cells

Read More: Precision Biologics                                                                                 

AffyImmune’s AIC100 Gains the US FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Recurrent Anaplastic Thyroid Cancer

Read More: Affylmmune                                                                                              

Arcutis Reports the sNDA Submission of Zoryve Foam to the US FDA for Treating Scalp and Body Psoriasis

Read More: Arcutis                                                                                                       

BioMarin Pharmaceutical Reports the US FDA’s Approval of Brineura (cerliponase alfa) to Treat Neuronal Ceroid Lipofuscinosis Type 2

Read More: BioMarin Pharmaceutical                                                                     

ConSynance Therapeutics’ CSTI-500 Receives the US FDA’s Rare Pediatric Disease Designation to Treat Prader-Willi Syndrome

Read More: ConSynance Therapeutics                                                                    

Pfizer Reports the EC’s Conditional Approval of Durveqtix (Fidanacogene Elaparvovec) for the Treatment of Hemophilia B

Read More: Pfizer                                                                                                           

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata

Read More: Sun Pharma                                                                                            

AbbVie’s Skyrizi (Risankizumab) Receives the EC’s Approval to Treat Moderate to Severe Active Ulcerative Colitis

Read More: AbbVie                                                                                                   

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

Read More: LEO Pharma                                                                                         

Merck Reports the CHMP’s Positive Opinion of Keytruda Plus Padcev to Treat Unresectable or Metastatic Urothelial Carcinoma

Read More: Merck                                                                                                   

 

Aligos Therapeutics Partners with Xiamen Amoytop Biotech for the Development of ALG-000184

Read More: Aligos Therapeutics & Amoytop Biotech                                      

Pinetree Therapeutics Collaborates with AstraZeneca to Develop its Preclinical Candidate

Read More: Pinetree Therapeutics & AstraZeneca                                              

Triastek Partners with BioNTech to Develop 3D Printed Oral RNA Therapeutics

Read More: Triastek & BioNTech                                                                              

Ipsen Collaborates with Day One Biopharmaceuticals for the commercialization of Tovorafenib to Treat Pediatric Low-Grade Glioma

Read More: Ipsen & Day One Biopharmaceuticals                                                  

Dren Bio Partners with Novartis to Discover and Develop Novel Targeted Myeloid Engagers for Cancer

Read More: Dren Bio & Novartis                                                                                 

 

Restore Medical’s ContraBand System Gains the US FDA’s Breakthrough Device Designation for Heart Failure with Reduced Ejection Fraction

Read More: Restore Medical                                                                                      

THINK Surgical Gains the US FDA’s Approval for TMINI Miniature Robotic System (TMINI 1.1)

Read More: THINK Surgical                                                                                       

 

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Read More: Samsung Bioepis                                                                                    

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Read More: Bio-Thera                                                                                              

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Read More: Bio-Thera                                                                                               

 

Edwards Lifesciences to Acquire JenaValve Technology and Endotronix, Strengthening its Structural Heart Portfolio

Read More: Edwars Lifesciences, JenaValve Technology & Endotronix             

Related Post: PharmaShots Weekly Snapshots (July 15 – July 19, 2024)

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