Data Show Three Years of Continuous Treatment with Leqembi Reduces Cognitive Decline in Patients with Early Alzheimer Disease
Results of the Phase III Clarity AD study found that Leqembi reduced cognitive decline by -0.95 on the Clinical Dementia Rating-Sum of Boxes compared to expected declines in untreated groups.
FDA Approves Johnson & Johnson’s Darzalex Faspro in Combination with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
Results from the PERSEUS study led to the FDA approval of Darzalex Faspro in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
Women’s Healthcare: Will Changing Laws Inhibit Latest Innovations in Fertility and Birth Control Treatments?
With a growing number of legal battles over women’s health issues, such as abortion and infertility, stakeholders are concerned about the impact on everything from healthcare access to new technology.
Employers Express Concern Over Rising Healthcare Costs, Citing Specialty Medications Like GLP-1s: Report
The report also details steps that employers are taking to manage the cost of healthcare plans for employees.
Pharma Pulse 7/31/24: Forgetting the Patient, Five Fast Facts About IVIG & more
The latest news for pharma industry insiders.
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder
Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says.
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
NRx Receives Response From FDA Over Testing Use of Ketamine for Suicidal Depression in Adolescents
The company announced that it will conduct research based on guidance from the agency.
AvaSure Acquires Ouva and Adds Smart Room Solutions to its Platform
Ouva’s AI-powered technology will be added to AvaSure’s digital platform.
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
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.
