Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab, identifies advertising/marketing trends he expects in Q1 of 2025.
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Vaccines After COVID: Biopharma's Renewed Public Health and Commercial Push
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed the potential of mRNA technology in developing cancer vaccines amid distrust from the public.
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Key Findings of the NIAGARA and HIMALAYA Trials
In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE…
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Biotech Investor Sentiment Climbing Steadily, with Growing Enthusiasm Heading into 2025
The sector’s XBI is up 15% year-to-date; rate cuts, election outcome, and M&A are viewed as tailwinds.
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FDA Approves Johnson & Johnson’s Varipulse for Drug-Resistant Paroxysmal Atrial Fibrillation
The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.
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Financial Times Global Pharma and Biotech Summit: The Impact of the Election
How will President Trump’s return to office impact the pharma industry?
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Strategies for the Looming Pharma Patent Cliff
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed ways to prepare for the high number of incoming patent expiries and how to protect key drugs.
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How to Bring World’s Most Innovative Treatments to Least Wealthy Places
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed initiatives aimed at bringing cell and gene therapies to low- and middle-income countries.
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Dealmaking and Partnerships: The Future of Financing Innovation
At the Financial Times’ Global Pharma and Biotech Summit 2024, a breakout panel discussed how dealmaking remains vital for biopharma companies facing pipeline and revenue pressures.
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Global Pharma and Biotech Summit: The Impact of Politics on Pharma and Biotech
Amgen CEO Robert A. Bradway discusses the potential impact of the election, and politics in general, will have on the industry.
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Balancing Personalized Targeting with Protecting Consumer Privacy
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discusses the need to balance personalized targeting with the ethical imperative to protect consumer privacy.
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Pharma Pulse 11/4/24: Community Pharmacies in Crisis, Insights Into ADHD Diagnoses in Adult Women & more
The latest news for pharma industry insiders.
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Viking Therapeutics Presents Positive Data from VK2735 for Reducing Body Weight Effectively and Safely
Results from the VENTURE Phase II trial and a Phase I oral formulation study found that VK2735, a novel a dual GLP-1 and GIP receptor agonist, demonstrated promise in treating obesity.
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Recent Developments in Pharmaceutical Validation
Explore the latest pharmaceutical validation developments with industry experts from Barry-Wehmiller Design Group, Kneat Solutions, and No Deviation. You’ll gain valuable data-driven insights and discover emerging trends from the State of Validation 2024 industry report that are shaping the validation landscape.
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Biopharma Needs a Health System Strategy to Secure Optimal Market Access
In today’s pharmaceutical market access landscape, payers are not the sole decision-makers in utilization management development.
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Pharma Pulse 11/1/24: Navigating Diversity and Digital Innovation, Key Clinical Information on Infertility & more
The latest news for pharma industry insiders.
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Eisai Completes Rolling Biologics License Application to FDA for Subcutaneous Maintenance Dosing Option of Leqembi for Alzheimer Disease
The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.
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Wegovy Demonstrates Superiority Over Placebo in Patients with Metabolic Dysfunction-Associated Steatohepatitis
Results from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved a 37% improvement in liver fibrosis without worsening steatohepatitis in patients with metabolic dysfunction-associated steatohepatitis compared to 22.5% in the placebo group.
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Key Benefits of RWD in Privacy and Targeting Effectiveness
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has evolved in the healthcare industry in terms of privacy and targeting effectiveness.
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AbbVie, EvolveImmune Therapeutics Strike Deal to Develop Biotherapeutics for Resistant Cancer Cells
The deal is expected to leverage EvolveImmune’s T-cell engager EVOLVE platform to develop novel antibody-based therapies for solid and hematologic malignancies.
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Expanded Access Treatment Options: Q&S with Johnson and Johnson Innovative Medicine’s Christine MacCracken
The executive director of patient strategies & solutions discusses J&J’s new Guide to Expanded Access.
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Daiichi Sankyo, AstraZeneca Launch Phase III Trials of Datopotamab Deruxtecan in Advanced Nonsquamous Non-Small Cell Lung Cancer
The trials will investigate datopotamab deruxtecan in combination with treatments including rilvegostomig, osimertinib, and chemotherapy in patients with nonsquamous non-small cell lung cancer.
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To Tackle the Plastic Waste Crisis in Pharma, Here’s Where to Start
By demonstrating big advancements in recycling, pharma companies will be much more likely to attract shareholders and other investors, giving themselves a leg up in the competition to lead the biopharmaceutical industry well into the future.
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FDA Approves Protega Pharmaceuticals’ Roxybond for Severe Pain Management
Roxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via intranasal and intravenous routes.
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Long-Term Implications of Ongoing Drug Shortages
Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding explore the potential long-term implications of the ongoing drug shortages for the healthcare system and patient care.
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Merck, Moderna Launch Phase III Trial of V940 in Combination with Keytruda for Resectable Non-Small Cell Lung Cancer
Collaboration seeks to advance the treatment of non-small cell lung cancer by combining Keytruda with Moderna’s novel neoantigen therapy, which has shown positive results across cancer types.
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Strengthening Regulatory Framework for Compounded Medications
Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding explain how the regulatory framework for compounded medications can be further strengthened to ensure quality and safety, while still maintaining flexibility to address patient needs.
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MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.
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Fake Weight Loss Drugs: Growing Threat to Consumer Health
In this episode of the Pharmaceutical Executive podcast, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
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Pharma Pulse 10/25/24: Improving Site-Sponsor Collaboration, Communication Skills Crucial for Patient Safety & more
The latest news for pharma industry insiders.
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Report: Radiopharmaceutical Market Expected to Reach $26.51 Billion by 2031
Growth is expected due to increased instances of chronic diseases such as cancer and Alzheimer disease.
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AbbVie, Gedeon Richter Ink Deal to Develop Novel Targets for Neuropsychiatric Conditions
Under terms of the deal, Richter will receive an upfront cash payment of $25 million, along with potential future development, regulatory, and commercialization milestones.
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Identifying Illicit Actors vs Compound Pharmacies
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, explains how to identify a compound pharmacy versus and illicit actor.
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The Impact of Artificial Intelligence on the Creation of Medicines
Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
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Pharma Pulse 10/24/24: Safeguarding Customer Data, Price Transparency Reveals Inequities Beyond Patients & more
The latest news for pharma industry insiders.
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Young & Partners Pharmaceutical Executive Summit 2024: Brave New World – Where Are We Heading?
Peter Marks, director, Center for Biologics Evaluation and Research, FDA, presented the keynote presentation on the future of gene therapy as part of the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
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Qnovia CEO to Speak at Public Meeting with FDA and NIH
The meeting is set to focus on advancing smoking cessation.
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Sanofi, CD&R Ink Deal to Support Consumer Healthcare Company Opella
Under terms of the deal, Sanofi would sell a 50% controlling stake in Opella to CD&R, while remaining a significant shareholder.
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Pharma Marketing Trends to Expect in 2025
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member identifies marketing trends you expect to be big right away in 2025.
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FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands
Regulatory action marks the fourth aesthetic indication and the first beyond facial treatments for Botox.
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Will Pharma Increase Use of Personalized Audio Use in Marketing?
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how personalized audio will be utilized within the pharma marketing industry in 2025.
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Measuring the ROI of Marketing Efforts
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how CMOs effectively measure the return on investment (ROI) of their marketing efforts in the pharmaceutical industry, particularly in light of the long-term nature of drug development and…
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Johnson & Johnson Details Six Ways it Utilizes AI
The company includes the technology in drug development, improving efficiency, and other areas.
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Healthcare Companies in Florida Partner to Provide Hurricane Relief
Sun Life U.S. teamed up with several other Florida-based companies to provide needed assistance in areas impacted by the recent storms.
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FDA Approves Expanded Indication for Lumryz in Pediatric Patients with Narcolepsy
Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.
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FDA Grants Priority Review to GSK’s Gepotidacin for Uncomplicated Urinary Tract Infections
Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.
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Pharma Pulse 10/18/24: Driving Diversity with the Integrated Research Model, More Treatment Options for Schizophrenia & more
The latest news for pharma industry insiders.
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Sanofi, Orano Strike Deal to Develop Radioligand Medicines for Rare Cancers
Partnership is expected to develop radioligand therapies based on lead-212 alpha-emitting isotopes, which offer the opportunity to destroy cancer cells with minimal damage to healthy tissue.
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Mirikizumab Demonstrates Superiority to Ustekinumab in Treating Crohn Disease
Results from the Phase III Vivid-1 trial found that more Crohn disease patients treated with mirikizumab achieved histologic response at week 52 compared to ustekinumab.
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Nipocalimab Demonstrates Sustained Disease Control in Adolescents with Generalized Myasthenia Gravis
Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.
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Pharmaceutical Executive: October 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive October 2024 issue in an interactive PDF format.
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Rafaat Rahmani: Beating the Odds
Rafaat Rahmani, president and founder of Lifescience Dynamics, grew up in abject poverty, but such hardships—and a later violent brush with racism—would ultimately end up fueling a determined and entrepreneurial path in the life sciences.
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‘Selling a Vision’: Today’s Playbook for Startups
The Big Pharma commercialization playbook doesn’t work for emerging life sciences companies bootstrapping their way up. Exploring three strategies that could be the ingredients of a winning formula for startups.
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Amwins Expands Gene Therapy Coverage
The program will now cover 15 gene and cell therapies.
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Integrating Digital Solutions to Enhance Traceability and Safety in Drug Administration
Laura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.
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Amazon Targeting the Transactional in the Pharma Market
A value deficit and potential consumer value proposition.
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Trading Quality for Convenience? The New Tech Balancing Act
Announcements such as Apple’s come with pros and cons for industry.
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FDA Approves Roche’s Itovebi for Endocrine-Resistant, PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
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How to Rally a Team Around Building a New Business
Three key components to scaling quickly—while maintaining purpose.
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FDA Grants Marketing Authorization for Healgen Scientific’s Home Flu and COVID-19 Combination Test
Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA without emergency use authorization.
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Arexvy Demonstrates Sustained Protection From Respiratory Syncytial Virus in Adults Over 60 Years of Age for Three Seasons
Data from the Phase III AReSVi-006 clinical trial found that Arexvy offered a cumulative efficacy of 62.9% against lower respiratory tract disease caused by respiratory syncytial virus.
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DarioHealth Announces Partnership with National Medicare Advantage Plan
The partnership will provide plan members with access to digital services aimed at older patients.
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FDA Grants Breakthrough Therapy Designation to Biogen’s Felzartamab for Late Antibody-Mediated Rejection in Kidney Transplants
Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.
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FDA Grants Breakthrough Therapy Designation to Boehringer Ingelheim’s Survodutide for Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis
Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.
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Astellas, AviadoBio Strike Exclusive Option, License Agreement for Potential Treatment for Frontotemporal Dementia
Under terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat frontotemporal dementia with progranulin mutations.
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AstraZeneca, CSPC Pharmaceutical Group Reach Exclusive Licensing Agreement to Develop Lipid-Lowering Therapy
Under the agreement, AstraZeneca will be granted access to CSPC’s small molecule candidate, YS2302018, with the goal of treating dyslipidemia and cardiovascular disease.
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FDA Approves Increased Dosage of Biofrontera’s Ameluz Topical Gel for Actinic Keratosis
Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.
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BCS Financial Introduces Employer Group Gene Therapy Stop Loss
The stop loss is designed to protect against potentially massive costs related to gene therapy treatments.
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Combating Diseases with Limited Investment Incentives: Q&A with Dr. Claire Wagner
Dr. Wagner discusses her work with the Bill and Melinda Gates Medical Research Institute.
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Hologic Launches Breast Cancer Myth Busting Campaign
The campaign is called #BustTheMyth and is aimed at patient education.
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FDA Approves Bristol Myers Squibb’s Opdivo in Combination with Chemotherapy for Resectable Non-Small Cell Lung Cancer
Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.
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FDA Approves Exact Sciences' Cologuard Plus Non-Invasive Colorectal Cancer Screening Test
Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.
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Pharma Pulse 10/4/24: Regulatory Challenges With Data Collection, Poor Sleep Quality Linked to Dementia & more
The latest news for pharma industry insiders.
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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.
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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.
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Transforming Patient Care Management: Q&A with Dea Belazi
The AscellaHealth CEO discusses how new technologies are increasing the options in patient care.
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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.
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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.
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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.
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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.
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The Future of Periodontal Treatment
Advancements in periodontal disease could make way for expansions in the dental space and other medical fields.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Robert A. Michael Becomes AbbVie CEO
As previously announced, Michael assumed the role on July 1.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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UltraSight Announces Partnership with Butterfly Garden AI-Marketplace
UltraSight will join the AI marketplace.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Advancing Bispecific Biologic Therapies for Solid Tumors and Blood Cancers
In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses how AbbVie is advancing the development of bispecific biologic therapies in both solid tumors and blood cancers.
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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.
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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
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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.
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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.
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Aidoc AI Software Used to Reduce Missed Follow Up Appointments
The company announced updates to its software to focus on this issue.
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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.
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Preventing Bias in AI: Q&A with Michael Armstrong
The CTO of Authenticx discusses preventing bias from becoming part of AI models.
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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.
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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.
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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.
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FDA Approves Botanix Pharmaceuticals’ Sofdra for the Treatment of Primary Axillary Hyperhidrosis
Approval of Sofdra marks the first chemical entity to be approved by the FDA to treat primary axillary hyperhidrosis.
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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.
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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 tumor types.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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A Novel Approach to Therapeutic Delivery Across the Blood-Brain Barrier
Aliada Therapeutics’ chief scientific officer, John Dunlop, PhD, discusses the MODEL platform.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Pharma Pulse 6/6/24: 3 in 4 Americans Under 65 Concerned About Future of Medicare, The Future of BYOD Adoption & more
The latest news for pharma industry insiders.
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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.
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The Surprising Inefficiency of Field Deployments
Deployments are often built on the concept that growth comes from new prescribers, which may be limiting their success.
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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.
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Patients and Data Disrupt the Life Sciences Industry
Delivering better patient outcomes hinges on innovation and adaptability.
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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.
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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.
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Managing Diversity: Q&A with Tom Harvey
Alkermes’ chief information officer discusses how he helped develop and build a welcoming workplace.
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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.
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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.
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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.
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Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
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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.
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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.
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FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer
Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer.
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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.
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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.
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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.
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The Case for Pharma, AI, and Israel: Q&A with Mati Gill
The CEO of AION Labs discusses both the new ways that AI is being implemented in drug development and why Israel is becoming the center of AI development in the pharma industry.
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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.
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Pharma Pulse 5/27/24: New Study on Physician Compensation, Overwork, and Shortage, Evolving Clinical Research & more
The latest news for pharma industry insiders.
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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.
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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.
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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.
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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.
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Cityblock Health Announces Further Partnerships with Centene Corporation to Bring Value-Based Healthcare to Florida
Cityblock is partnering with Sunshine Health in Florida.
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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.
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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.
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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.
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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.
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Durect’s Larsucosterol Receives FDA Breakthrough Therapy Designation for Severe Alcohol-Associated Hepatitis
Moving forward, Durect plans on incorporating feedback from the FDA in the design of a Phase III trial.
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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…
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US Pharma and Biotech Summit 2024: Solving Drug Pricing
Experts discuss how attempts to solve the drug pricing problem in the US are working.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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FDA Grants Accelerated Approval to Breyanzi for Relapsed or Refractory Follicular Lymphoma
This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.
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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.
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Leveraging Lessons from Commercialization and Distribution of Rare Products for Cell and Gene Therapy
In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses ways that cell and gene therapy developers can follow examples from the commercialization and distribution of orphan drugs.
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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.
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'Patients are Waiting'
This month, we spotlight the inspiring story of the Healthcare Businesswomen’s Association Woman of the Year, Yvonne Greenstreet.
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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.
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A Biosimilars Roadmap: Understanding Payer Perceptions
With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount.
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Improving the US Supply Chain for Better Patient Outcomes
Improving the US Supply Chain for Better Patient Outcomes
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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.