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

Merck and Gilead Highlight the P-II Study Data of Islatravir Plus Lenacapavir in Virologically Suppressed People with HIV at IDWeek 2024

Read More: Merck and Gilead

Roche Reports 1-Year Data from P-IV (ELEVATUM) Study of Vabysmo (Faricimab) in Patients with Diabetic Macular Edema (DME)

Read More: Roche

Alto Neuroscience’s P-IIb Trial of ALTO-100 for Major Depressive Disorder Couldn’t Achieve its Primary Endpoint

Read More: Alto Neuroscience

Hope Medicine Reports the Data from P-II Trial of HMI-115 for Treating Endometriosis

Read More: Hope Medicine

Alkeus Pharmaceuticals Reports Topline Results from SAGA Trial of Gildeuretinol (ALK-001) for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Read More: Alkeus Pharmaceuticals

Zai Lab Highlights the Data from P-Ia/Ib Trial of ZL-1310 for Treating Extensive-Stage Small Cell Lung Cancer at ENA Symposium 2024

Read More: Zai Lab

Abbott Commences New Clinical Trial to Enhance Patient Outcomes in Advanced Heart Failure

Read More: Abbott

EyePoint Pharmaceuticals Reports the First Patient Dosing in P-III (LUGANO) Study of Duravyu to Treat Wet Age-Related Macular Degeneration

Read More: EyePoint Pharmaceuticals

AbbVie Reports the US FDA’s Approval of Botox Cosmetic (OnabotulinumtoxinA) for Moderate to Severe Vertical Bands Connecting the Jaw and Neck

Read More: AbbVie

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Read More: AstraZeneca and Ionis

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

Read More: Astellas

BeiGene Reports the CHMP’s Positive Opinions for Tevimbra as a 1L Treatment of G/GEJ Cancer and Esophageal Squamous Cell Carcinoma

Read More: BeiGene

Adcentrx Therapeutics Reports the US FDA’s IND Clearance of ADRX-0405 to Treat Advanced Solid Tumors

Read More: Adcentrx Therapeutics

Eli Lilly Reports the MHRA’s Approval of Kisunla (Donanemab) to Treat Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease

Read More: Eli Lilly

HiberCell’s HC-7366 Gains the US FDA’s Fast Track Designation for Treating Acute Myeloid Leukemia (AML)

Read More: HiberCell

Merck Reports EC’s Approval of Keytruda for Two New Indications in Gynecologic Cancers

Read More: Merck

Accent Therapeutics Receives the US FDA’s IND Approval of ATX-559 for Treating Breast Cancer

Read More: Accent Therapeutics

Angelini Pharma Join Forces with Cureverse to Develop and Commercialize CV-01 for Brain Health

Read More: Angelini Pharma and Cureverse

Avacta Therapeutics Collaborates with Tempus AI to Commence AI-Driven Drug Development in Oncology

Read More: Avacta Therapeutics and Tempus AI

GSK Enters into a 5-Year Partnership with Cambridge University to Address Kidney and Respiratory Diseases

Read More: GSK

Telix Spins Off Rhine Pharma to Broaden Global Radiopharmaceutical Reach

Read More: Telix

Eccogene Reports the First Patient Dosing with ECC5004/AZD5004 in P-IIb Trial of Obesity and T2D, Triggering $60M Milestone from AstraZeneca

Read More: Eccogene and AstraZeneca

EydisBio Receives $0.5M Grant to Support the Development of TAK1 Inhibitor Program for Alzheimer's Disease

Read More: EydisBio

AbbVie Inks Pact with Gedeon Richter to Discover and Develop Novel Targets for Neuropsychiatric Conditions

Read More: AbbVie and Gedeon Richter

Dyno Therapeutics Collaborates with Roche to Develop AAV Gene Therapy Vectors for Neurological Diseases

Read More: Dyno Therapeutics and Roche

Teal Health Reports the Regulatory Submission of Teal Wand to the US FDA for Cervical Cancer Screening

Read More: Teal Health

Ocuphire Pharma to Acquire Opus Genetics

Read More: Ocuphire Pharma

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara)

Read More: Dong-A ST

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Read More: Alvotech and Teva

Poseida Therapeutics to Feature Non-Clinical Data of P-KLKB1-101 for Treating Hereditary Angioedema at ACAAI 2024

Read More: Poseida Therapeutics

Related Post: PharmaShots Weekly Snapshots (October 14 – October 18, 2024)