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