SPOTLIGHT -
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease
Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.
FDA Approves Sun Pharma’s Leqselvi for Treating Adults with Severe Alopecia Areata
Leqselvi is classified as a novel oral Janus Kinase inhibitor that targets JAK1 and JAK2 pathways, thought to be involved in the autoimmune response that leads to alopecia areata.
ReviR Therapeutics Announces Funding Haul for Oral Genetic Treatments
The company plans to develop these treatments using it’s AI-powered platform.
Experts Discuss the Importance of Genomic Sequencing in the Battle Against HIV in South Africa
MGI Tech Co. issued a statement detailing the use of its technology in improving the rates of genomic sequencing in South Africa.
Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer
FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.
FDA Clears Investigational New Drug Application for Actinium Pharmaceuticals’ Iomab-ACT in Patients with Sickle Cell Disease
The study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole with Sertraline for Adults with Post-Traumatic Stress Disorder
The supplemental New Drug Application for brexpiprazole in combination with sertraline is supported by data from three randomized clinical trials that evaluated its safety and efficacy in adult patients with post-traumatic stress disorder.
FDA Expands Indication of BioMarin Pharmaceutical’s Brineura to Include Children with Neuronal Ceroid Lipofuscinosis Type 2 Disease
Expanded indication of Brineura allows for treatment of neuronal ceroid lipofuscinosis type 2 disease in both symptomatic and presymptomatic children.
Giroctocogene Fitelparvovec Demonstrates Superiority over Factor VIII Prophylaxis in Reducing Annual Bleeding Rate in Patients with Moderate to Severe Hemophilia A
A single dose of giroctocogene fitelparvovec significantly reduced the mean total annual bleeding rate in patients with moderately severe to severe hemophilia A.
Pharma Pulse 7/25/24: Driving CAR-Ts for Treatment in Cancer and Immunology, CrowdStrike Explains What Went Wrong in Global Outage & more
The latest news for pharma industry insiders.
Sage and Biogen Halt Phase II Study After Novel Drug Shows No Significant Improvement in Treating Essential Tremor
Moving forward, Sage Therapeutics and Biogen intend to cease further clinical development of SAGE-324 for essential tremor.
Phase III Trial Data Demonstrates Efficacy of Lenacapavir in Preventing HIV in Cisgender Women
Results of the PURPOSE 1 trial indicated that treatment with lenacapavir was superior to Descovy and Truvada.
CVS Caremark Issues Statement of Role of PBMs
The PBM defined its core values and what role it believes PBMS should play in the industry.
Vivacelle Bio Launches Phase III Clinical Trial for VBI-S to Treat Hypovolemic Septic Shock
The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors.
FDA Approves Merz Aesthetics’ Xeomin for Simultaneous Treatment of Upper Facial Lines
The new approval expands Xeomin’s indications to include horizontal forehead lines and lateral canthal lines.
Johnson & Johnson Submits Supplemental New Drug Application to FDA for Spravato as Monotherapy for Adults with Treatment-Resistant Depression
Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.
Antheia Announces $17 Million in Funding for Domestic Pharmaceutical Ingredient Production
The company received the money through a government project agreement.
Is There a Correlation Between Medical Debt and Delayed Mental Health Care in the United States?
JAMA study aims to determine whether financial barriers impact access to mental health services.
South Korean Company Announces Development of Oral GLP-1 Treatment
Dx&Vx identified multiple potential drug candidates using AI-based technology.
Genomics plc Extends Partnership with Vertex Pharmaceuticals
The two companies will continue to collaborate on the use of machine learning in improving precision medicine development.
FDA Approves Voquezna for GERD Treatment
This is the latest approval for Phathom Pharmaceutical’s GI treatment.
FDA Grants Orphan Drug Designation to Mabwell’s Treatment of Small Cell Lung Cancer
Novel drug 7MW3711 binds to tumor cell membrane antigens, being internalized and transported to the lysosome, releasing a cytotoxic drug, and inducing tumor cell apoptosis.
CT-996 Demonstrates Significant Weight Loss in Patients with Obesity and Type 2 Diabetes
Treatment with CT-996 led to a significant placebo-adjusted mean weight loss of 6.1% within four weeks in participants with obesity but without type 2 diabetes.
Texas A&M Health Teams With BurstIQ to Improve Genomic Research Data Governance
The tech company’s data platform will be implemented into the genomic research department’s workflow.
Member Defense Network Launches to Prevent Unauthorized Switching in ACA Marketplace
The network includes organizations that represent over 45,000 agents and brokers.
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders
Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer
The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors.
SOTIO Biotech, Biocytogen Ink Research and License Agreement to Develop Next-Generation Antibody-Drug Conjugates
The agreement enables SOTIO to license multiple fully human bispecific antibodies from Biocytogen's RenLite platform.
Anthem Blue Cross and Allied Pacific IPA Announce Partnership with Astrana Health Inc.
The two companies will use Astrana’s technology offerings to improve access.
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia
DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability.
