PharmaShots Weekly Snapshots (February 05 – February 09, 2024)


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 Grants IND Clearance to Acepodia’s ACE2016 to Treat Solid Tumors

Read More: Acepodia                                                    

The EMA Accepts Regeneron’s MAA for Linvoseltamab as a Treatment for Multiple Myeloma (MM)

Read More: Regeneron                                               

The US FDA Reclassifies High-Risk IVDs from Class III to Class II

Read More: US FDA                                                      

The US FDA Grants FTD to Biosyngen’s BST02 for the Treatment of Liver Cancer

Read More: Biosyngen                                                    

The NMPA Accepts Innovent’s NDA for Mazdutide as a Treatment for Overweight or Obese Adults

Read More: Innovent                                                  

The US FDA and EMA Accept BMS’ sBLA for Opdivo Combination Therapy for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Read More: BMS                                                                      

 

Pliant Therapeutics Highlights the P-II Results of Bexotegrast 320mg to Treat Primary Sclerosing Cholangitis and Suspected Liver Fibrosis

Read More: Pliant Therapeutics                                                   

EyePoint Pharmaceuticals Highlights the P-II Results for EYP-1901 to Treat Wet Age-Related Macular Degeneration

Read More: EyePoint Pharmaceuticals                                                     

Sanofi Reports Results for Nexviazyme (avalglucosidase alfa) in Clinical Evaluation for the Treatment of Pompe Disease

Read More: Sanofi                                                                               

Vividion Therapeutics Initiates P-I Trial of VVD-130850 for Treating Advanced Solid and Hematologic Tumors

Read More: Vividion Therapeutics                                                                

The US FDA Accepts GSK’s sBLA of Arexvy and Grants Priority Review for Preventing RSV Disease

Read More: GSK                                                                                              

GSK Highlights the P-III Results for Blenrep (belantamab mafodotin) in Combiantion with BorDex (dexamethasone) to Treat Multiple Myeloma

Read More: GSK                                                                                         

Johnson & Johnson Highlights the Results from 2 Trials of Nipocalimab to Treat Generalized Myasthenia Gravis (gMG) and Sjögren’s Disease (SjD)

Read More: Johnson & Johnson                                                  

REGENXBIO Highlights the Clinical Trial Results for RGX-121 to Treat Mucopolysaccharidosis Type II (MPS II)

Read More: REGENXBIO                                                             

Madrigal Pharmaceuticals Highlights the P-III Results for Resmetirom in NASH Patients

Read More: Madrigal Pharmaceuticals                                          

Takeda Highlights the Results for TAK-861 in P-IIb Trials and Expects to Advance into P-III Trial for the Treatment Narcolepsy Type 1

Read More: Takeda                                                                   

 

For an Aggregate of ~$2.9B in Cash, Novartis to Acquire MorphoSys 

Read More: Novartis & MorphoSys                                                 

For an Aggregate of ~$1.3B, Merck Animal Health to Acquire Elanco’s Aqua Business

Read More: Merck Animal Health & Elanco                                        

Immunome Reports the Acquisition of Ayala Pharmaceuticals’ AL102 to Treat Desmoid Tumors

Read More: Immunome & Ayala Pharmaceuticals                                        

To Enhance its Oncology Segment, Telix to Acquire QSAM Biosciences

Read More: Telix & QSAM Biosciences                                              

Jazz Pharmaceuticals to Acquire Redx Pharma’s KRAS Inhibitor Program

Read More: Jazz Pharmaceuticals & Redx Pharma                                             

 

Venus Medtech Reports Health Canada’s Approval for VenusP-Valve System 

Read More: Venus Medtech                                          

The US FDA Grants the 510(k) Clearance to StimLabs’ Corplex P as a Management Therapy for Acute and Chronic Wounds

Read More: StimLabs                                                                

The US FDA Clears IntuiTap Medical’s VerTouch to Perform Spinal Punctures Accurately

Read More: IntuiTap Medical                                                                 

The US FDA Grants a 510(k) Clearance to Fresenius Medical Care’s 5008X Hemodialysis System as a Dialysis Therapy for Kidney Disease Patients 

Read More: Fresenius Medical Care                                                                 

 

BridgeBio Pharma Enters into a Collaborative Agreement with Kyowa Kirin to Develop and Commercialize Infigratinib for the Treatment of Skeletal Dysplasias in Japan

Read More: BridgeBio Pharma & Kyowa Kirin                                                                 

Nicox and Kowa Partner to Develop and Commercialize NCX 470 in Japan

Read More: Nicox & Kowa                                                                     

Samsung Biologics and LegoChem Biosciences Partner for the Development and Manufacturing of ADC Programs

Read More: Samsung Biologics & LegoChem Biosciences                       

Vicore and Nippon Shinyaku Partner to Develop and Commercialize C21 in Japan

Read More: Vicore & Nippon Shinyaku                                                      

BioInvent and AstraZeneca have Entered into a Clinical Supply Agreement to Assess BI-1206 for Treating Non-Hodgkin’s Lymphoma

Read More: BioInvent & AstraZeneca                                                     



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