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

AstraZeneca Provides Update on P-III (CAPItello-281) Study of Truqap Regimen in PTEN-Deficient mHSPC

Read More: AstraZeneca

Orbus Therapeutics Reports the P-III (STELLAR) Trial Data of Eflornithine Plus Lomustine to Treat Recurrent Astrocytoma IDH Mutant Grade 3

Read More: Orbus Therapeutics

Merck Reports Results from the P-III (ZENITH) Study of Winrevair (Sotatercept-csrk) for Pulmonary Arterial Hypertension

Read More: Merck

MaaT Pharma Reports Results from the P-Ib (IASO) Study of MaaT033 for Treating Amyotrophic Lateral Sclerosis (ALS)

Read More: MaaT Pharma

Amgen Reports 52 Weeks Data from P-II Trial of Maritide in Obese People with or without Type 2 Diabetes

Read More: Amgen

Telix Pharmaceuticals Reports the First Patient Dosing in P-III (ZIRCON-CP) Trial of TLX250-CDx for Kidney Cancer Imaging in China

Read More: Telix Pharmaceuticals

Galderma Publishes the P-III (OLYMPIA 1) Trial of Nemolizumab for Prurigo Nodularis in JAMA Dermatology

Read More: Galderma

UroGen Pharma Reports Long-Term Data from OLYMPUS Trial of Jelmyto for Upper Tract Urothelial Cancer

Read More: UroGen Pharma

Merck’s Welireg (Belzutifan) Receives Chinese Approval to Treat Certain Types of Von Hippel-Lindau (VHL) Disease-Related Tumors

Read More: Merck

GSK Reports the US FDA’s BLA Acceptance of Blenrep (Belantamab Mafodotin) Regimen for Treating R/R Multiple Myeloma

Read More: GSK

Johnson & Johnson Submits sBLA to the US FDA for Subcutaneous Induction Regimen of Tremfya (Guselkumab) for Ulcerative Colitis

Read More: Johnson & Johnson 

StemCyte Reports the US FDA’s Approval of Regenecyte Cord Blood Cell Therapy Product

Read More: StemCyte

Alnylam Pharmaceuticals Reports the US FDA’s sNDA Acceptance of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy

Read More: Alnylam Pharmaceuticals

Intellia Therapeutics’ Nexiguran Ziclumeran Secures the US FDA’s RMAT Designation to Treat Hereditary Transthyretin (ATTR) Amyloidosis with Polyneuropathy

Read More: Intellia Therapeutics

Novartis’ Kisqali (Ribociclib) Secures EC’s Approval as an Adjuvant Treatment of HR+/HER2- Early Breast Cancer

Read More: Novartis

GSK’s Menveo Secures the EC’s Approval to Prevent Invasive Meningococcal Disease

Read More: GSK

BeiGene’s (to be BeOne Medicines) Tevimbra Secures the EC’s Approval as a 1L Treatment of Esophageal Squamous Cell Carcinoma and G/GEJ Cancer

Read More: BeiGene

Lin BioScience’s LBS-007 Secures the US FDA’s Fast Track Designation to Treat Acute Myeloid Leukemia

Read More: Lin BioScience

Applied Therapeutics Receives Complete Response Letter for Govorestat’s NDA for Treating Classic Galactosemia

Read More: Applied Therapeutics

AOP Health’s Rapiblyk (landiolol) Receives the US FDA’s Approval for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

Read More: AOP Health

CervoMed’s Neflamapimod Secures the US FDA’s Orphan Drug Designation to Treat Frontotemporal Dementia

Read More: CervoMed

Acadia Pharmaceuticals Collaborates with Saniona to Develop and Commercialize SAN711

Read More: Acadia Pharmaceuticals and Saniona

Arrowhead & Sarepta Sign a Global Licensing and Collaboration Agreement for Multiple Clinical and Preclinical Programs

Read More: Arrowhead & Sarepta

Allink Biotherapeutics Secures $42M to Support the Development of Bispecific Antibody and ADC Pipeline

Read More: Allink Biotherapeutics

Formosa and Medvisis Partner for Clobetasol Propionate Ophthalmic Suspension to Treat Post-Operative Inflammation and Pain

Read More: Formosa and Medvisis

BrioHealth Solutions Initiates Patient Recruitment in INNOVATE Trial of BrioVAD System for Advanced Heart Failure

Read More: BrioHealth Solutions

Roche to Acquire Poseida Therapeutics for ~$1.5B

Read More: Roche and Poseida Therapeutics

Merck Animal Health Receives the EC’s Approval of BRAVECTO TriUNO for Use in Dogs

Read More: Merck Animal Health

Boehringer Ingelheim Introduces Vetmedin Solution (Pimobendan Oral Solution), for Congestive Heart Failure in Dogs

Read More: Boehringer Ingelheim

SELLAS Reports Data from Preclinical Studies Suggesting ASXL1 Mutations as Predictor of SLS009 Response in Solid Tumors

Read More: SELLAS

Related Post: PharmaShots Weekly Snapshots (November 18 – November 22, 2024)