This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:
Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis
Read More: Oculis
PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)
Read More: PharmaEssentia
MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease
Read More: MaaT Pharma
Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies
Read More: Bayer
Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma
Read More: Astellas
NMD Pharma’s NMD670 Secures the US FDA’s Orphan Drug Designation to Treat Charcot-Marie-Tooth Disease
Read More: NMD Pharma
Ultragenyx Reports the EC’s Approval of Evkeeza (evinacumab) to Treat 6-Months Old Children with Homozygous Familial Hypercholesterolemia (HoFH)
Read More: Ultragenyx
Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC
Read More: Amgen
Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease
Read More: Fortress Biotech and Cyprium Therapeutics
GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma
Read More: GSK
Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)
Read More: Johnson & Johnson
Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer
Read More: Astellas
JCR Pharmaceuticals and Modalis Progress into the Next Phase of Joint Research Agreement to Develop Gene Therapy
Read More: JCR Pharmaceuticals and Modalis
Orna Collaborates with Vertex to Develop Gene Therapies for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)
Read More: Orna and Vertex
Alloy Therapeutics Partners with Sanofi to Advance Innovative Therapeutics in the CNS Space
Read More: Alloy Therapeutics and Sanofi
Avenzo Therapeutics Join Forces with DualityBio to Develop AVZO-1418 (DB-1418) for Solid Tumors
Read More: Avenzo Therapeutics and DualityBio
Biocytogen Partners with Acepodia to Develop Bispecific Antibody and Dual-Payload ADCs to Treat Complex Tumors
Read More: Biocytogen and Acepodia
Novo Nordisk Expands its Partnership with Valo Health to Discover and Develop Novel Therapies for Cardiometabolic Diseases
Read More: Novo Nordisk and Valo Health
Boehringer Ingelheim Licenses Synaffix’s Technology to Boost its ADC Portfolio in Oncology
Read More: Boehringer Ingelheim and Synaffix
Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System
Read More: Simpson Interventions
Stryker to Acquire Inari Medical for ~$4.9B
Read More: Stryker and Inari Medical
Hologic Completes the Acquisition of Gynesonics for ~$350M
Read More: Hologic and Gynesonics
Boston Scientific to Acquire Bolt Medical, Strengthening its Cardiovascular Portfolio
Read More: Boston Scientific and Bolt Medical
ScreenPoint Medical Reports the Acquisition of Biomediq, Bolstering its Breast Cancer Risk Evaluation Capabilities
Read More: ScreenPoint Medical and Biomediq
Vividion Therapeutics to Bolster its Genomic Abilities Through the Acquisition of Tavros Therapeutics
Read More: Vividion Therapeutics and Tavros Therapeutics
Transcarent to Acquire Accolade for ~$621M
Read More: Transcarent and Accolade
Veralox Therapeutics to Acquire Nudge Therapeutics, Expanding its Portfolio
Read More: Veralox Therapeutics and Nudge Therapeutics
GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)
Read More: GlycoNex
Absci Corporation Collaborates with Invetx to Develop AI-Based Drug Creation Platform for Animal Health
Read More: Absci Corporation and Invetx
Light Horse Therapeutics Partners with Novartis to Discover Therapies for Cancer Treatment
Read More: Light Horse Therapeutics and Novartis
Related Post: PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)
