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)