PharmaShots Weekly Snapshots (December 18 – December 22, 2023)

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PharmaShots Weekly Snapshots (December 18 – December 22, 2023)

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

The US FDA Approves Merck’s Keytruda + Padcev for the Treatment of Urothelial Cancer

Read More: Merck                                                                                                         

The US FDA Approves Arcutis’s Zoryve (roflumilast) for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

Read More: Arcutis                                                                                                       

The US FDA Approves GC Biopharma’s Alyglo for the Treatment of Primary Humoral Immunodeficiency  

Read More: GC Biopharma                                                                                         

 The European Commission Extended the Approval for Ultragenyx’s Evkeeza to Treat 5 Years or Older Children with Homozygous Familial Hypercholesterolemia (HoFH)

Read More: Ultragenyx                                                                                           

Anheart Therapeutics & Innovent’s NDA for Taletrectinib Receives Acceptance by the NMPA and Receives Priority Review Designation for Non-Small Cell Lung Cancer

Read More: Anheart Therapeutics & Innovent                                                 

Merck’s BLA for V116 Accepted by the US FDA and Receives Priority Review for the Prevention of Pneumococcal Disease  

Read More: Merck                                                                                                  

ImPact Biotech Receives the US FDA’s Clearance on IND Application to Initiate P-I Evaluation of Padeliporfin VTP in Pancreatic Cancer

Read More: ImPact Biotech                                                                                   

The US FDA has granted Calliditas Therapeutics’ Tarpeyo Full Approval for IgA Nephropathy to Reduce the Loss of Kidney Function

Read More: Calliditas Therapeutics                                                                

The US FDA Approves AstraZeneca and Ionis’s Wainua (eplontersen) to Treat Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Read More: AstraZeneca & Ionis                                                                    

 The US FDA has Granted 510(k) Clearance to Alcresta Therapeutics’ RELiZORB Digestive Enzyme Cartridge 

Read More: Alcresta Therapeutics                                                                        

The US FDA Grants RMAT Designation to 4DMT for 4D-150 to Treat Wet Age-Related Macular Degeneration 

Read More: 4DMT                                                                                                    

Janssen Report the Marketing Authorization Application to the EMA for Lazertinib Plus Rybrevant to Treat Lung Cancer

Read More: Janssen                                                                                                  

Innovent Highlights the Results of P-II Study for Mazdutide (IBI362) in Chinese Patients with Overweight or Obesity

Read More: Innovent                                                                                                   

Innocare Highlights the Results of P-II Study for ICP-332 in Patients with Atopic Dermatitis

Read More: Innocare                                                                                                  

Neuren Highlights the P-II Trial Results for NNZ-2591 to Treat Children with Phelan-McDermid Syndrome (PMS)

Read More: Neuren                                                                                                  

Aldeyra Therapeutics Highlight the P-II Trial Results of ADX-629 for the Treatment of Atopic Dermatitis

Read More: Aldeyra Therapeutics                                                                     

GSK Highlights Data from the P-III (RUBY) Trial of Jemperli (dostarlimab) + Zejula (niraparib) for Endometrial Cancer

Read More: GSK                                                                                                  

Sanofi Discontinues its P-III (CARMEN-LC03) Trial of Tusamitamab Ravtansine for Non-Squamous Non-Small Cell Lung Cancer

Read More: Sanofi                                                                                              

Immunovant Highlights the P-II Trial Results of Batoclimab for the Treatment of Graves’ Disease

Read More: Immunovant                                                                                  

Bausch Health Reveals P-II Trial Results of Amiselimod for the Treatment of Ulcerative Colitis

Read More: Bausch Health                                                                            

GQ Healthcare Entered into a Strategic Collaboration with BioMap to Co-Develop FIC/BIC ADC Therapeutics 

Read More: GQ Healthcare & BioMap                                                               

Ionis and Otsuka have Collaborated to Develop and Commercialize Donidalorsen for Hereditary Angioedema (HAE) in Europe

Read More: Ionis & Otsuka                                                                                   

Gilead and Compugen have Collaborated to Develop COM503, a Novel Pre-Clinical Immunotherapy Program

Read More: Gilead & Compugen                                                                         

Biocytogen and Neurocrine Biosciences have Entered into a Multi-Target Antibody Agreement 

Read More: Biocytogen & Neurocrine Biosciences                                            

GSK and Hansoh Pharma Enter into a Collaboration Agreement for HS-20093 to Treat Solid Tumors

Read More: GSK & Hansoh Pharma                                                                     

Fauna Bio Enters into a Strategic Collaboration Agreement with Eli Lilly to Discover Obesity Targets through Convergence AI Platform

Read More: Fauna Bio & Eli Lilly                                                                            

 IntelGenx and Covenant Animal Health Collaborate to Develop and Manufacture VetaFilm-Based Products for Animal Use 

Read More:  IntelGenx & Covenant Animal Health                                           

Koning Health Enters into a Strategic Collaboration with Gentle Scan Health to Enhance Breast Cancer Detection Across the United States 

Read More: Koning Health & Gentle Scan Health                                            

The US FDA Grants 510(k) Clearance to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for the Treatment of Strokes

Read More: Perfuze                                                                                        

AXIM Biotechnologies Collaborates with Auer Precision for the Production of T-POC TOTAL IgE Immunoassay and T-POC LACTOFERRIN Immunoassay

Read More: AXIM Biotechnologies & Auer Precision         

Related Post:- PharmaShots Weekly Snapshots (December 11 – December 15, 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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