Pharma Pulse 7/26/24: Research Shows Promise Toward Universal Flu Vaccine, AI Struggles with Math & more
The latest news for pharma industry insiders.
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 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.
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 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.
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.
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.
Pharma Pulse 7/23/24: Post-Roe, How Safe are Period-Tracking Apps? Where to Invest in Health Trends & more
The latest news for pharma industry insiders.
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.
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.
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.
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.
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.
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.
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.
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.
Congress, Have a More Thoughtful, Bipartisan Pandemic Post-Mortem
Congress and our nation’s public health officials should take the current moment to self-reflect and resolve challenges with public confidence in our public and scientific institutions.
Transforming Patient Care Management: Q&A with Dea Belazi
The AscellaHealth CEO discusses how new technologies are increasing the options in patient care.
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.
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.
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.
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.
The Future of Periodontal Treatment
Advancements in periodontal disease could make way for expansions in the dental space and other medical fields.
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.
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
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.
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.
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.
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.
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.
Pharma Pulse 7/8/24: New AI Tech Spurs Excitement/Concerns Among Private-Credit Managers, Future Perspectives on Atopic Dermatitis Treatment & more
The latest news for pharma industry insiders.
Robert A. Michael Becomes AbbVie CEO
As previously announced, Michael assumed the role on July 1.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
UltraSight Announces Partnership with Butterfly Garden AI-Marketplace
UltraSight will join the AI marketplace.
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.
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.
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.
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.
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.
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.
Citius Pharmaceuticals Co-Founder and CEO Talks Promising Results from a Phase III Clinical Trial for Mino-Lok, a Treatment Designed to Salvage Catheters in Patients with Central-Line Associated Infections
In an interview with Pharm Exec Associated Editor Don Tracy, Leonard Mazur, Co-Founder, CEO, Citius Pharmaceuticals, discusses recent topline results from the pivotal Phase III Clinical Trial of Mino-Lok, which works to salvage catheters infections.
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.
Pharma Pulse 6/26/24: Empowering Women in Pharmacy, AI is Helping Scammers & more
The latest news for pharma industry insiders.
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.
EXO Biologics CEO Discusses Innovation in Developing Exosome Therapies
Hugues Wallemacq, CEO of EXO Biologics, discusses the company’s innovative approach to developing scalable and GMP-compliant exosome therapies and ambitious plans to reshape the global therapeutic landscapes.
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.
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
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.
Aidoc AI Software Used to Reduce Missed Follow Up Appointments
The company announced updates to its software to focus on this issue.
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.
Preventing Bias in AI: Q&A with Michael Armstrong
The CTO of Authenticx discusses preventing bias from becoming part of AI models.
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.
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.
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.
What the Leaders of the Most Effective Teams Know
Findings from hundreds of interviews of exceptional pharma leaders around the world.
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.
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.
FDA Approves Merck’s Keytruda in Combination with Carboplatin and Paclitaxel to Treat Advanced or Recurrent Endometrial Carcinoma
Approval of Keytruda combination for patients with primary advanced or recurrent endometrial carcinoma is based on results from the NRG-GY018/KEYNOTE-868 clinical trial, which was Phase III trial to evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with two distinct…
New Survey Says Digital Health Care Technology Is Benefitting Payers
Health insurance executives say that digital technologies are getting members more involved in the healthcare system.
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.
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.
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.
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.
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.
Movano Health Announces Addition of Deep Learning Software to AI-Powered Heart Rate Monitoring Software
According to the company, the additional software makes it algorithm more accurate.
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.
Pharma Pulse 6/13/24 : PBMs Start to Embrace Biosimilars, Novo Nordisk Threatens Lego’s Position in Denmark & more
The latest news for pharma industry insiders.
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.
Weight Loss Drug Shortage Prompts Multiple Companies to Launch Shortage Tracking Platforms
Hypermedica and Ro announced platforms to help patients find access to affordable weight loss medications.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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…
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…
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.
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.
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.
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.
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.
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.
Managing Diversity: Q&A with Tom Harvey
Alkermes’ chief information officer discusses how he helped develop and build a welcoming workplace.
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.
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.
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.
Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
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.
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.
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.
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.
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.
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.
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.
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.
Pharma Pulse 5/27/24: New Study on Physician Compensation, Overwork, and Shortage, Evolving Clinical Research & more
The latest news for pharma industry insiders.
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.
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.
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.
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.
Cityblock Health Announces Further Partnerships with Centene Corporation to Bring Value-Based Healthcare to Florida
Cityblock is partnering with Sunshine Health in Florida.
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.
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.
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.
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.
US Pharma and Biotech Summit 2024: Bringing the Skillset of Generation Alpha to the Pharma Industry
In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses new skills that members of generation Alpha will bring to the pharma industry and potential struggles that they may face.
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…
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development.
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.
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.
AbbVie, Gilgamesh Pharmaceuticals Agree to Terms on a Collaboration to Develop Advanced Therapies for Psychiatric Disorders
The joint venture aims to address unmet needs in the treatment of mood and anxiety disorders through novel neuroplastogens.
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.
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.
Patient Treatment & Travel: The Need for Stepped-Up Support
Designing an effective travel and lodging patient hub program in pharma.
Improving the US Supply Chain for Better Patient Outcomes
Improving the US Supply Chain for Better Patient Outcomes
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.
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…
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.
Biotech’s Road to Recovery Takes a Wobbly Turn
Now-unclear timing on rate cuts puts onus back on fundamentals.
Avoiding the Digital Age is Hurting Research Efforts
A greater shift from paper records and physical assets is achievable.
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.
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
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.
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®
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.
Mark Cuban’s Cost Plus Drug Company Partners with RxLink
RxLink will incorporate Cost Plus’ prices into its drug pricing platform MedMap.
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.
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.
Poseida Therapeutics Enters into Partnership with Astellas Subsidiary Xyphos
The two companies will work together to develop gene therapies in oncology.
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.
Pharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more
The latest news for pharma industry insiders.
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.
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.
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…
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.
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.
Shifting Priorities and Perceptions in Revenue Management
In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, discusses the changing dynamics today for companies in revenue management and planning—and the increasing importance of a well-tooled and well-trusted analytics component in fueling product launch,…
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.
FDA Grants Full Approval to Tivdak for Treating Recurrent or Metastatic Cervical Cancer Patients Experiencing Disease Progression After Chemotherapy
Approval of Tivdak was based on promising results from a Phase III innovaTV 301 clinical trial, which demonstrated a 30% reduction in the risk of death in patients with recurrent or metastatic cervical cancer.
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.
FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers
Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers.
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.
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.
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.
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
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.
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.
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.
FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females
Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
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.
Coya Therapeutics CEO Discusses Next Steps Amid Positive Results from Coya 302 Trial for ALS Treatment
In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a preview on what the nexts steps are after presenting positive data on Coya 302 for the treatment of ALS.
FDA Approves Amneal’s Naloxone Hydrochloride Nasal Spray as an OTC Treatment for Opioid Overdose
Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids.
FDA Approves Novartis' Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors
Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
FDA Approves ImmunityBio’s Anktiva for the Treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.
Current State of the Pharma Sales and Marketing Sales Force
Industry executives dive into trends like utilizing AI and influencers for content creation, personalizing messages to the patient, combatting the spread of misinformation and much more in the video version of our executive roundtable discussion
Expanse Ice Receives FDA 510(k) Clearance for ICE Aspiration System for Peripheral Arterial, Venous Systems
Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.
Lene Oddershede Discusses Upcoming Projects from the Novo Nordisk Foundation
In an interview with Pharm Exec Associate Editor Don Tracy, Lene Oddershede, SVP, Natural & Technical Sciences, Novo Nordisk Foundation offers a synopsis of upcoming projects from the Novo Nordisk Foundation.
Will Synthetic, AI-Based Digital Humans Change Pharma and Life Sciences? Q&A with Abid Rahman, SVP Innovation, EVERSANA
Rahman discusses the new opportunities that digital twins present to researchers.
FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC
Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.
FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease
Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.
Essential Pharma Acquires Reminyl, a Cholinesterase Inhibitor to Treat Mild to Moderately Severe Dementia from Janssen Pharmaceutica NV
Acquisition includes rights to marketing in the European Economic Area, Thailand, South Korea, and other regions for oral treatment of mild to moderately severe dementia associated with Alzheimer disease.
Texas Biomed Developing Potential Bird Flu Vaccine
While human infections of the virus are rare, a strain recently appeared in dairy cows before infecting a human in Texas.
Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis
According to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks 12 to 52.
The Real Cost of State Drug Importation Programs? Patient Safety
Importing drugs from Canada may increase the risk of US citizens being exposed to unsafe medicines.
GSK’s Five-in-One Meningococcal Vaccine Under Review by the FDA
With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis.
Pharmaceutical Executive: April 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive April 2024 issue in an interactive PDF format.
At-Home Patients and AI: Q&A with Riccardo Butta
Butta discusses how new technologies are being implemented in at-home devices.
The IRA Impact: Navigating Its Evolving Complexities
Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their strategic planning process—and do it now.
Maneuvering the Rapid Demand
In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses why their drug isn’t experiencing the same supply issues as the bigger names in the space.
Fighting for Innovation
Damien Bailly, president of established markets at Astellas, discusses why partnerships and collaborations are a critical organizational—and wider ecosystem—imperative in ensuring that patients have access to the medicines they need.
Novartis Initiates Voluntary Public Takeover of MorphoSys AG
The takeover is contingent upon a minimum acceptance rate of 65% and other conditions outlined in the offer document.
Supply Shortages in Weight Loss Drugs
In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses factors that are contributing to ongoing supply issues and if prices for these therapies are coming down anytime soon.