Medicine Archives - Page 3 of 5

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

AvaSure Acquires Ouva and Adds Smart Room Solutions to its Platform

Ouva’s AI-powered technology will be added to AvaSure’s digital platform.

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

Fighting the Drop in Vaccination Rates: Q&A with Gregg Sylvester

An unexpected consequence of the COVID 19 pandemic has been a loss in trust of vaccines. Over the past three flu seasons, there has been a drop in vaccination rates that is alarming experts. Dr. Gregg Sylvester, chief health officer at CSL Seqirus, spoke with Pharmaceutical Executive about the causes of the decline and how […]

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

Pharma Pulse 7/26/24: Research Shows Promise Toward Universal Flu Vaccine, AI Struggles with Math & more

The latest news for pharma industry insiders.

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

Pharma Pulse 7/22/24: J.D. Vance’s AI Agenda, Fighting the Flu With Supplements & more

The latest news for pharma industry insiders.

Medicine

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.

Medicine

4 Essential Approaches for Effective Brand Narratives

By embracing technology and integrating it seamlessly into your brand narrative, you can create a more engaging, personalized, and effective experience for HCPs.

Medicine

South Korean Company Announces Development of Oral GLP-1 Treatment

Dx&Vx identified multiple potential drug candidates using AI-based technology.

Medicine

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.

Medicine

FDA Approves Voquezna for GERD Treatment

This is the latest approval for Phathom Pharmaceutical’s GI treatment.

Medicine

Pharma Pulse 7/19/24: Sentiments Surrounding At-Home Diagnostic Testing, Smaller Drugmakers Step Up Hunt for Acquisitions & more

The latest news for pharma industry insiders.

Medicine

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.

Medicine

Pharma Pulse 7/18/24: Improving Medication Reconciliation Accuracy, Synchron Says AI Will Be Instrumental for Devices & more

The latest news for pharma industry insiders.

Medicine

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.

Medicine

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.

Medicine

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.

Medicine

Pharma Pulse 7/16/24: New Class of Medicine for Pain Relief On The Horizon, Emotional Intelligence Training Sets New Law Enforcement Standard & more

The latest news for pharma industry insiders.

Medicine

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.

Medicine

FDA Clears Artelo Biosciences’ Investigational New Drug Application for Chemotherapy-Induced Peripheral Neuropathy Treatment

Clearance of the New Drug Application for ART25.12 allows Artelo to begin a Phase I study for the drug in chemotherapy-induced peripheral neuropathy.

Medicine

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.

Medicine

Transforming Patient Care Management: Q&A with Dea Belazi

The AscellaHealth CEO discusses how new technologies are increasing the options in patient care.

Medicine

Drug Shortages May Have a Compounding Solution: Q&A with Shawn Hodges

The CEO of Revelation Pharma discusses how compounding pharmacies may help solve the ongoing issue with drug shortages.

Medicine

Pharma Pulse 7/12/24: The Relationship Between Patients and Drug Shortages, Rise of the Restaurant Robots & more

The latest news for pharma industry insiders.

Medicine

Amylyx Pharmaceuticals Acquires Phase III-Ready GLP-1 Receptor Agonist Avexitide for Hyperinsulinemic Hypoglycemia from Eiger BioPharmaceuticals

Avexitide has received Breakthrough Therapy Designation by the FDA for post-bariatric hypoglycemia, congenital hyperinsulinism, and more.

Medicine

Cohort Study Compares Weight Loss Effects of Tirzepatide vs. Semaglutide

JAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults.

Medicine

The Future of Periodontal Treatment

Advancements in periodontal disease could make way for expansions in the dental space and other medical fields.

Medicine

How Leaders Can Empower Their People to be Their Best

If you wish for your team to be diligent, innovative, and collaborative, you must first exhibit these traits yourself

Medicine

Making the Grade: Registries as Sources of Regulatory-Grade RWE

Dr Peter Wahl, MLA, MS, Global Head of Scientific Affairs at CorEvitas, part of Thermo Fisher Scientific, covers key considerations for choosing registries.

Medicine

FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

Zoryve is a steroid-free, once-daily treatment shown to offer rapid disease clearance and significant itch reduction for patients with mild to moderate atopic dermatitis.

Medicine

What Happens to Out-of-Pocket Costs When Patients with Type 2 Diabetes Reach the Medicare Age?

JAMA study evaluates changes to out-of-pocket costs and utilization of type 2 diabetes medications once patients reach the age of 65 years.

Medicine

Can Data and AI Deliver Whole-Person Health?

Executives in the life sciences and medical device industries see promise in artificial intelligence (AI) and medical technologies, but must also navigate the changing healthcare ecosystem, varied stakeholder needs, and the impact of AI on market access and commercialization strategies.

Medicine

FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

Medicine

FDA Approves Genentech’s Vabysmo to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema Following Retinal Vein Occlusion

The Vabysmo prefilled syringe is designed to simplify administration for retina specialists, improving the treatment experience for both physicians and patients with wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.

Medicine

FDA Grants Full Approval to Johnson & Johnson’s Sirturo for Pulmonary Tuberculosis Caused by Mycobacterium Tuberculosis Resistant to Rifampicin and Isoniazid

Results from the Phase III STREAM Stage 2 study show the efficacy and safety of an all-oral bedaquiline-containing regimen for multidrug-resistant pulmonary tuberculosis.

Medicine

Robert A. Michael Becomes AbbVie CEO

As previously announced, Michael assumed the role on July 1.

Medicine

Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy

Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies.

Medicine

PrimeRx Launches Digital Platform for Pharmacy Drug Ordering

The platform is similar to other recent digital platforms in that it is designed to reduce drug costs.

Medicine

Pharma Pulse 7/3/24: What to Know About New and Future ALZ Drugs, Bridging the Gap Between Innovation and Implementation & more

The latest news for pharma industry insiders.

Medicine

Pharma Pulse 7/5/24: The Impact of FDA's Diversity Action Plan, Apple Poised to Get OpenAI Board Observer Role & more

The latest news for pharma industry insiders.

Medicine

Femasys Founder Discusses Femaseed Technology Designed to Support Infertility

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, offers a description of how Femaseed works to support women who struggle with infertility.

Medicine

Pharma Pulse 7/4/24: Colder Temperatures May Worsen Asthma Symptoms, New FDA Approved ALZ Drug to Accelerate New Era of Treatment & more

The latest news for pharma industry insiders.

Medicine

Michael J. Fox Foundation and Parkinson’s UK Award $5.2 Million to Mission Therapeutics for Research into Potential Parkinson’s Treatment

MTX325 is in Phase I trials and is believed to be able to modify the course of the disease.

Medicine

Health In Tech Announces New Partnerships to Expand Health Insurance Options for Employers in Southern Ohio

The company announced that it has partnered with Adena Health and The Ohio State University Health Plan Solutions.

Medicine

Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus.

Medicine

FDA Approves Lilly’s Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

Kisunla is the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, company says.

Medicine

FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

Medicine

AI’s Promise in Delivering on Patient-Centricity

How pharmaceutical companies can utilize AI at key stages of the treatment journey to enhance patient-centric engagement by increasing empathy and humanity in patient interactions.

Medicine

FDA Approves New Drug Application for Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation for the Treatment of Breast and Ovarian Cancer

Reportedly, the liquid formulation of Tepylute eliminates the need for complex and time-consuming reconstitution, providing consistent dosing accuracy and allowing for timely preparation.

Medicine

UltraSight Announces Partnership with Butterfly Garden AI-Marketplace

UltraSight will join the AI marketplace.

Medicine

Pharma Pulse 6/28/24: Acupuncture Decreases Hot Flashes, The Benefits of Using AI in Data Management & more

The latest news for pharma industry insiders.

Medicine

Citius Pharmaceuticals Co-Founder and CEO Discusses the Recently Accepted Biologics License Application of Lymphir for the Treatment of Relapsed/Refractory CTCL

In an interview with Pharm Exec Associate Editor Don Tracy, Leonard Mazur, Co-founder, CEO, Citius Pharmaceuticals, offers an update on the recently accepted Biologics License Application for Lymphir by the FDA and other candidates currently in the Citius pipeline.

Medicine

FDA Approves Verona’s Ohtuvayre for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease

Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years.

Medicine

CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants

The inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward.

Medicine

With CEO Turnover Rising to Record Levels, How Can Incoming, Existing Executives Build a Sustainable Role?

A Q&A with Russell Reynolds’ Global Lead of CEO & Executive Transition Practice, Ty Wiggins, PhD.

Medicine

FDA Issues Complete Response Letter to Merck and Daiichi Sankyo for Patritumab Deruxtecan for Advanced, Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

The Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.

Medicine

FDA Approves Genmab’s Epkinly to Treat Adults with Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

Approval of Epkinly was based on results from the Phase I/II EPCORE trial in patients with relapsed or refractory follicular lymphoma who have already completed two or more lines of systemic therapy.

Medicine

FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder

Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.

Medicine

Eli Lilly, OpenAI Strike Collaboration Agreement Seeking to Discover New Antimicrobials to Fight Drug-Resistant Bacteria

The collaboration with OpenAI is part of Lilly’s strategy to combat drug-resistant pathogens through its Social Impact Venture Capital Portfolio.

Medicine

Novo Nordisk to Invest $4.1 Billion in Expanding Manufacturing Capabilities in the United States

Investment is expected to fund a new fill and finish manufacturing facility to enhance production of injectable treatments for obesity and chronic diseases.

Medicine

FDA Grants Premarket Approval to Endotronix’s Cordella Pulmonary Artery Sensor System to Support Patients with Heart Failure

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.

Medicine

FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older.

Medicine

Improving the Efficacy of Genetic Medicines

Shawn Davis, CEO of Liberate Bio, shares some insights into the world of drug discovery, development, and delivery, as well as process optimization

Medicine

Novel Therapy Shows Significant Promise Slowing Parkinson Disease Progression

Data from an early phase trial published in Nature found that Parkinson disease patients treated with UB-312 experienced significant improvements in motor functions and daily living.

Medicine

Aidoc AI Software Used to Reduce Missed Follow Up Appointments

The company announced updates to its software to focus on this issue.

Medicine

Pharma Pulse 6/21/24: Improving Access to Trials Through Decentralization & Flexible Design, South Africa Runs Out of Insulin Pens & more

The latest news for pharma industry insiders.

Medicine

Preventing Bias in AI: Q&A with Michael Armstrong

The CTO of Authenticx discusses preventing bias from becoming part of AI models.

Medicine

Phase III Trial Data Show Lenacapavir Demonstrated 100% Efficacy Preventing HIV in Cisgender Women

Results of the PURPOSE 1 trial indicated that a twice-yearly injection of lenacapavir outperformed the once-daily oral Truvada preventing HIV in cisgender women.

Medicine

FDA Expands Approval of Sarepta Therapeutics’ Elevidys for the Treatment of Duchenne Muscular Dystrophy

Expansion of Elevidys includes patients over the age of four years with Duchenne muscular dystrophy regardless of their ambulatory status.

Medicine

Beyond the Numbers: Extrapolating Today’s Trends Forward

Q&A with Evaluate’s Paul Verdin digs deeper into the data-backed drivers likely to sway the future growth and jockeying of biopharma’s top players.

Medicine

What the Leaders of the Most Effective Teams Know

Findings from hundreds of interviews of exceptional pharma leaders around the world.

Medicine

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer.

Medicine

FDA Approves AbbVie’s Skyrizi for the Treatment of Adults with Moderate to Severely Active Ulcerative Colitis

Approval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.

Medicine

FDA Approves AstraZeneca’s Imfinzi for Mismatch Repair Deficient Primary Advanced or Recurrent Endometrial Cancer

The approval of Imfinzi was based on the DUO-E Phase III trial, which indicated that in combination with chemotherapy, the drug reduced the risk of disease progression or death by 58% in mismatch repair deficient endometrial cancer.

Medicine

FDA Approves Amgen’s Blincyto to Treat CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia

The approval of Blincyto was based on results from the Phase III E1910 clinical trial, which found that the treatment significantly improved overall survival in CD19-positive, Ph-negative B-cell ALL compared to chemotherapy alone.

Medicine

Lamassu Pharma Bridges Scientific Knowledge and Patient Care

Gabi Hanna, MD, CEO and Co-Founder of Lamassu Pharma talks about a novel oncology platform and the link between science and patient care.

Medicine

2024 Pharm Exec Top 50 Companies

Highlighted by notable company and product maneuvering at the top and the continued dramatic growth of therapeutic settings such as GLP-1s, Pharm Exec’s latest listing of the top global biopharma sales producers is proof-positive of an industry in transition.

Medicine

Opposite Spectrums

Our June issue of Pharmaceutical Executive offers a uniquely diverse range of coverage and voices—a “sum-of-its-parts” balance that’s not always easy to pull off.

Medicine

Pharmaceutical Executive: June 2024 Issue (PDF)

Click the title above for a link to open the Pharmaceutical Executive June 2024 issue in an interactive PDF format.

Medicine

Imbruvica Demonstrates Long-Term Efficacy, Safety in First-Line Treatment of Chronic Lymphocytic Leukemia

Data presented at the European Hematology Association Congress indicated that patients with chronic lymphocytic leukemia treated with Imbrivica had a significantly longer median progression-free survival compared to patients treated with chlorambucil.

Medicine

Craig Tooman: Silencing the Distractions

Craig Tooman, CEO of Silence Therapeutics, on steering through the rough biotech funding and investment waters post-pandemic—and how a retooled organizational approach has the company in a stronger position today in the growing field of gene silencing through siRNA drugs.

Medicine

Biopharma Leadership in Times of Transition

How pharma and biotech leaders can navigate today’s challenging landscape—focusing on revamped approaches in business operations, talent strategy and development, and more to meet the evolving demands.

Medicine

A Novel Approach to Therapeutic Delivery Across the Blood-Brain Barrier

Aliada Therapeutics’ chief scientific officer, John Dunlop, PhD, discusses the MODEL™ platform.

Medicine

Study Suggests Individuals Born Preterm Are More Likely to Have Lower Incomes in Adulthood

Investigators followed a group of people born from 1990-1996 to assess whether the association between preterm birth and income differs according to family socioeconomic status at birth.

Medicine

FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics.

Medicine

The Healthcare System is Changing—So How Should We Respond?

What pharma needs to do to keep up with the rise in value-based care.

Medicine

Survodutide Demonstrates Significant Improvement in Patients with Liver Fibrosis Associated with Metabolic Dysfunction-Associated Steatohepatitis

Survodutide is the first glucagon/GLP-1 receptor dual agonist to show a high level of benefit in treating liver fibrosis associated with metabolic dysfunction-associated steatohepatitis.

Medicine

FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.

Medicine

GSK Acquires Elsie Biotechnologies for $50 Million to Elevate Oligonucleotide Pipeline

Acquisition of Elsie Biotechnologies is expected to strengthen GSK’s research capabilities in modulating gene expression through the use of oligonucleotide.

Medicine

How ChatGPT Enterprise Changed Moderna's Use

In this part of his Pharmaceutical Executive video interview, Brice Challamel, Vice President, AI Products & Platforms, Moderna, discusses their internal AI chatbot tool, mChat, and how the launch of ChatGPT Enterprise changed things.

Medicine

Pharma Pulse 6/7/24: How Much Does a Day of Delay Really Cost? BranchLab Launches Privacy-Safe Healthcare Advertising Solution & more

The latest news for pharma industry insiders.

Medicine

Deerfield Agency Acquires Embedded, Launches New Life Sciences Marketing Brand

The new agency will operate under the name Deerfield Group, and will also include Verge Scientific Communications.

Medicine

Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

Medicine

FDA Approves Geron Corporation’s Rytelo to Treat Adults with Lower-Risk Myelodysplastic Syndromes

Approval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.

Medicine

Pharm Exec Exclusive: Mark Cuban Talks Drug Pricing

Now more than two years into launching his alternative and transparent drug payment model, the longtime entrepreneur, in an interview with Pharm Exec, discusses the prescription drug cost landscape and shares his recipe for true disruption to the pharma pricing machine.

Medicine

Bulevirtide Combination Therapy Shows Efficacy Achieving Undetectable Compensated Chronic Hepatitis Delta Virus RNA

Data published in the New England Journal of Medicine from Gilead’s Phase IIb MYR204 found the bulevirtide/ pegylated interferon alfa-2a combination was more effective in achieving undetectable HDV RNA compared to bulevirtide 10 mg monotherapy in the treatment of chronic hepatitis D.

Medicine

FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder.

Medicine

Johnson & Johnson Submits Supplemental New Drug Application to Expand Indication of Prezcobix for HIV-1 in Children at Least 6 Years Old

A similar application was also submitted to the EMA for the expanded use of Prezcobix to treat children aged 6 years and older with HIV.

Medicine

Moderna, Merck Present Promising Trial Data for a Combination of V940 with Keytruda for the Treatment of High-Risk Melanoma Following Complete Resection

After three years of study, the V940 and Keytruda combination demonstrated sustained benefits in recurrence-free survival and distant metastasis-free survival in patients with high-risk melanoma following complete resection.

Medicine

Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma.

Medicine

Data Presented at ASCO Show Improved Complete Response with Jemperli as a First-Line Treatment for Locally Advanced Rectal Cancer in Patients with Mismatch Repair Deficient Status

Results of the Phase II AZUR-1 trial show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status.

Medicine

Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer

Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.

Medicine

Managing Diversity: Q&A with Tom Harvey

Alkermes’ chief information officer discusses how he helped develop and build a welcoming workplace.

Medicine

Pharma Pulse 5/31/24: OpenAI Says Russia & China Used Its AI in Covert Campaigns, FDA Diversity-Related Documents for Clinical Trials & more

The latest news for pharma industry insiders.

Medicine

Regeneron Global Program Head of Linvosoltamab Discusses the Potential for Linvosoltamab to Become a Frontline Treatment for Multiple Myeloma

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvosoltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company’s Velocsuite technology.

Medicine

Virtual Therapeutics, Akili Interactive Strike Definitive Merger Agreement Seeking to Improve Mental Health Through Immersive Video Games

Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.

Medicine

Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery

Medicine

Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Medicine

FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.

Medicine

FDA Approves Tris Pharma’s Onyda XR, a Once-Daily, Extended-Release Oral Suspension for the Treatment of ADHD

Approval of Onyda XR marks the first liquid non-stimulant medication for attention-deficit hyperactivity disorder to hit the market in the United States.

Medicine

FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Medicine

FDA Grants Priority Review to Inavolisib for Advanced Hormone Receptor-Positive HER2-Negative Breast Cancer

Priority Review status for inavolisib is based on positive Phase III data showing the inavolisib-based regimen significantly extended progression-free survival in patients with hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Medicine

FDA Grants Fast Track Designation to AV-001 for Moderate-to-Severe Acute Respiratory Distress Syndrome

Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation.

Medicine

Johnson & Johnson Acquires Numab’s Investigational Antibody for the Treatment of Atopic Dermatitis

The acquisition of a novel therapy for atopic dermatitis includes an all-cash transaction totaling approximately $1.25 billion.

Medicine

Express Scripts Announces New Independent Pharmacy Focused Strategy

The company is collaborating with CPESN USA to bring more services to customers at independent pharmacies across the country.

Medicine

Pharma Pulse 5/27/24: New Study on Physician Compensation, Overwork, and Shortage, Evolving Clinical Research & more

The latest news for pharma industry insiders.

Medicine

Pharma Pulse 5/23/24: Healthcare Services Immigrant Children Need the Most, GoodRx Offers Discounts on Fertility Treatments & more

The latest news for pharma industry insiders.

Medicine

Using an Omnichannel Approach for a Successful Product Launch: Q&A with Ryan Quigley

Inizio’s chief operations officer discusses how pharmaceutical companies are tailoring their product launch strategies to meet the diverse needs of stakeholders.

Medicine

Leveraging Pre-Approval Information Exchange to Accelerate Product Success, Patient Access: Q&A with Alvana Maliqi

Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges.

Medicine

Pharma Pulse 5/24/24: Counsel Patients on Nutrition and Following a Balanced Diet Complementary to GLP-1s, Neuralink’s First Brain-Implant Patient Stays Upbeat & more

The latest news for pharma industry insiders.

Medicine

Cityblock Health Announces Further Partnerships with Centene Corporation to Bring Value-Based Healthcare to Florida

Cityblock is partnering with Sunshine Health in Florida.

Medicine

Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders.

Medicine

FDA Approves Phase III Trial Protocol for Laekna’s LAE002 Plus LAE001 Combination for the Treatment of Prostate Cancer

Approval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) patients.

Medicine

AstraZeneca, Nona Biosciences Strike Global License and Option Deal to Develop Monoclonal Antibodies for Tumor Targeted Therapies

Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones.

Medicine

US Pharma and Biotech Summit 2024: Improving Health Policy After the 2024 Election

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses best-case scenarios for health policy amid the 2024 presidential election.

Medicine

The Learning Advantage: How Strategic L&D Can Optimize Pharma Rotational Programs for Success

Companies offering post-grad rotational programs develop broad skillsets in new hires.

Medicine

US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA Part II

In an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses whether the FDA plans on restricting the use of AI and what the future could look like when it comes to machine learning.

Medicine

FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK.

Medicine

US Pharma and Biotech Summit 2024: The 2024 Presidential Election and the Pharma Industry

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry.

Medicine

Coya Therapeutics Receives $5 Million Investment from the Alzheimer’s Drug Discovery Foundation

Investment from the Alzheimer’s Drug Discovery Foundation (ADDF) aims to support the development of Coya 302, a therapeutic candidate for the treatment of frontotemporal dementia (FTD).

Medicine

Pharma Pulse 5/17/24: AI & ML Through the Eyes of the FDA, Johnson & Johnson to Acquire Proteologix & more

The latest news for pharma industry insiders.

Medicine

With Layoffs Continuing in 2024 and Employees Paralyzed by Fear for Their Jobs, How Can Leaders Address Crucial Real Problems?

A Q&A with Professor Frances Frei of the Harvard Business School, who discusses how leaders create the conditions for organizations and individuals to thrive by designing for excellence in operations, strategy, and culture.

Medicine

FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer.

Medicine

US Pharma and Biotech Summit 2024: When FDA Needs to Regulate AI

Tala Fakhouri spoke at the conference about FDA’s approach to determining when it even needs to regulate the usage of AI in the pharma industry.

Medicine

US Pharma and Biotech Summit 2024: Getting Pharma Ready for Generation Alpha

In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Scienes discusses the changes expected in the pharma industry that will come with the entry of younger professionals.

Medicine

US Pharma and Biotech Summit 2024: A Biotech Industry Overview

KOLs in the sector examine the current dealmaking landscape, including the status of available capital.

Medicine

US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA

In an interview with Pharm Exec Associate Editor Don Tracy at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development.

Medicine

US Pharma and Biotech Summit 2024: The View from Investors

Industry experts gather to discuss the current investor market and how the IRA may impact the industry in the coming years.

Medicine

FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in a Healthcare Setting

Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.

Medicine

Novo Holdings Acquires Majority Share of Single Use Support to Expand Life Science Tools, Diagnostics Portfolio

Novo Holdings is expected to acquire 60% of Single Use Support, with the remaining shares being held by Danaher and the company founders.

Medicine

Pharmaceutical Executive: May 2024 Issue (PDF)

Click the title above for a link to open the Pharmaceutical Executive May 2024 issue in an interactive PDF format.

Medicine

Results from FRONTIER 2 Trial Show Promise of Mim8 as a Potential Treatment for Hemophilia A

In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes.

Medicine

Today’s New Messaging Mix: The State of Pharma Marketing in 2024

Industry experts, in a roundtable discussion, explore the evolution of brand engagement in the age of AI, including the growing importance of message relevance—and, for pharma, going where the information is.

Medicine

Patient Treatment & Travel: The Need for Stepped-Up Support

Designing an effective travel and lodging patient hub program in pharma.

Medicine

Improving the US Supply Chain for Better Patient Outcomes

Medicine

Pharma Pulse 5/10/24: Medicare Advantage, Racing Along, Hits Some Speed Bumps, Anti-Obesity Drugs Global Strategic Business Report & more

The latest news for pharma industry insiders.

Medicine

Yvonne Greenstreet: Answering the Call

From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients.

Medicine

Addressing Unmet Needs with LP-284 for Relapsed/Refractory Lymphomas and Solid Tumors

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, discusses how LP-284 uniquely addresses unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors.

Medicine

Biotech’s Road to Recovery Takes a Wobbly Turn

Now-unclear timing on rate cuts puts onus back on fundamentals.

Medicine

Avoiding the Digital Age is Hurting Research Efforts

A greater shift from paper records and physical assets is achievable.

Medicine

Flagship Pioneering, Metaphore Biotechnologies Strike Deal with Novo Nordisk to Develop High-End Obesity Treatments

The collaboration is a part of a broader strategy to combat cardiometabolic and rare diseases.

Medicine

Ensuring Global Access to LP-284

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, talks about ensuring global access to LP-284, particularly in regions with limited resources

Medicine

Planning for Unique Challenges Faced by Cell & Gene Therapy Developers

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, discusses the unique challenges that developers of cell and gene therapies need to plan for when building their channel strategy.

Medicine

Assessing LP-284 with RADR for NHL and Other Targeted Cancers

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, explains which specific endpoints they’ll be looking at in the Phase I trial to assess LP-284’s potential efficacy and how the insights gained will be fed back into RADR®

Medicine

AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis

Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs.

Medicine

Mark Cuban’s Cost Plus Drug Company Partners with RxLink

RxLink will incorporate Cost Plus’ prices into its drug pricing platform MedMap.

Medicine

FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

Medicine

Phase II Apa-RP Study of Erleada Shows Promise in Treatment of Patients with High-Risk Localized Prostate Cancer Who Have Undergone Previous Radical Prostatectomy

Significant findings included a 100% biochemical recurrence-free rate at 24 months post-surgery in patients with high-risk localized prostate cancer.

Medicine

Poseida Therapeutics Enters into Partnership with Astellas Subsidiary Xyphos

The two companies will work together to develop gene therapies in oncology.

Medicine

FDA Grants Fast Track Designation to Amolyt Pharma’s Eneboparatide to Treat Hypoparathyroidism

Currently in Phase III of clinical trials, eneboparatide has shown promise in normalizing key calcium levels and improving bone health in patients with hypoparathyroidism.

Medicine

Pharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more

The latest news for pharma industry insiders.

Medicine

Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers.

Medicine

Cencora VP of Emerging Therapies Discusses Cell & Gene Therapy Distribution Strategies

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, offers a synopsis on what questions cell and gene therapy developers need to answer to inform their distribution strategy.

Medicine

Pricing Climate Impacting Commercial Considerations

In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, talks about the influence of Medicare Part D drug price negotiations on manufacturer go-to-market strategies and decision-making, and the industry’s response to the wider dialogue on pricing transparency.

Medicine

Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity

Partnership expected to utilize Walgreens’ pharmacies as recruitment and trial sites for a clinical study regarding obesity, weight issues, and type 2 diabetes, mainly in historically underrepresented groups.

Medicine

How Diverse Skills Can Drive Success in Biotech

In this Pharmaceutical Executive video interview, Chris Martin, Chief Commercial Officer, Verona Pharma, discusses which skills or experiences he thinks are most valuable for team members tasked with launching a novel treatment in a competitive market.

Medicine

FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases

New formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.

Medicine

FTC Ramps Up Efforts to Crackdown on Inaccurate Patent Listings in the FDA’s Orange Book

The move targets over 300 listings for 20 branded products from companies such as AstraZeneca, Novo Nordisk, and GSK that the agency said inhibits the generic drug market.

Medicine

FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee

Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

Medicine

A Decade in the Anti-Obesity Arena

Currax Pharmaceuticals CEO, George Hampton discusses what patient success has looked like for their oral anti-obesity medication, how expanded access can help with the world’s obesity epidemic, when prices should come down, and much more.

Medicine

FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years

Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.

Medicine

Exploring Luma & Luma Lab Connect

In this Pharmaceutical Executive video interview, Kalim Saliba, Chief Product Officer, Dotmatics discusses their Luma platform, Luma Lab Connect, and what this technology could mean for industry.

Medicine

Solving the First Mile Problem: Q&A with Mark Melton

Melton, customer advocacy executive at Magnolia, discusses how new technologies can be used to ensure data is accurate.

Medicine

CVS Health Announces New Work Force Development and Community Center in Louisiana

The center will offer local residents with opportunities and training to enter the pharmacy work force.

Medicine

FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B

Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.

Medicine

FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

Medicine

Coya Therapeutics CEO Discusses Company's Treatment Pipeline

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization’s pipeline.

Medicine

Going Beyond Visuals to Connect with Diverse Audiences

In this Pharmaceutical Executive video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One, discusses what other tactics healthcare marketers can utilize to connect with diverse audiences on a deeper level

Medicine

Novartis, Medicines for Malaria Venture Release Positive Results from Phase II/III Trial of Coartem for Infants with Malaria

Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

Medicine

Crafting Culturally Sensitive Messages to Reach Diverse Audiences and Improve Patient Outcomes

In this Pharmaceutical Executive video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but address their specific healthcare needs

Medicine