The deal is expected to leverage EvolveImmune’s T-cell engager EVOLVE platform to develop novel antibody-based therapies…
Category: Medicine
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.
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…
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…
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…
Long-Term Implications of Ongoing Drug Shortages
Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding explore…
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…
Strengthening Regulatory Framework for Compounded Medications
Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding explain…
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…
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…
Pharma Pulse 10/25/24: Improving Site-Sponsor Collaboration, Communication Skills Crucial for Patient Safety & more
The latest news for pharma industry insiders.
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.
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…
Identifying Illicit Actors vs Compound Pharmacies
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, explains how to identify a compound pharmacy…
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…
Pharma Pulse 10/24/24: Safeguarding Customer Data, Price Transparency Reveals Inequities Beyond Patients & more
The latest news for pharma industry insiders.
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…
Qnovia CEO to Speak at Public Meeting with FDA and NIH
The meeting is set to focus on advancing smoking cessation.
Pharma Marketing Trends to Expect in 2025
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and…
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.
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…
Measuring the ROI of Marketing Efforts
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and…
Johnson & Johnson Details Six Ways it Utilizes AI
The company includes the technology in drug development, improving efficiency, and other areas.
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…
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…
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…
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.
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…
Incyte Adds Dr. Pimple Popper to Atopic Dermatitis Initiative
Dr. Sandra Lee is joining the educational program, which originally launched last year.
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…
Assembly Required: Building Blocks in Biopharma
Highlighting two pieces beyond Pharm Exec’s October headliners that draw interesting parallels when it comes to…
Pharmaceutical Executive: October 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive October 2024 issue in…
Rafaat Rahmani: Beating the Odds
Rafaat Rahmani, president and founder of Lifescience Dynamics, grew up in abject poverty, but such hardships—and…
‘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.…
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…
Amazon Targeting the Transactional in the Pharma Market
A value deficit and potential consumer value proposition.
Trading Quality for Convenience? The New Tech Balancing Act
Announcements such as Apple’s come with pros and cons for industry.
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…
How to Rally a Team Around Building a New Business
Three key components to scaling quickly—while maintaining purpose.
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…
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…
DarioHealth Announces Partnership with National Medicare Advantage Plan
The partnership will provide plan members with access to digital services aimed at older patients.
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…
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…
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…
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…
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…
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.
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.
Hologic Launches Breast Cancer Myth Busting Campaign
The campaign is called #BustTheMyth and is aimed at patient education.
Pharma Pulse 10/4/24: Regulatory Challenges With Data Collection, Poor Sleep Quality Linked to Dementia & more
The latest news for pharma industry insiders.
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…
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…
Sun Pharma, Philogen Ink Global Commercialization Deal for Fibromun, an Anti-Cancer Immunotherapy
Under terms of the deal, Philogen will complete clinical trials for Fibromun, seek approval, and handle…
What Does the ‘Third Age’ Look Like for BioPharma Employees as They Plan for Longer Life Spans?
A Q&A with Dr. Ken Dychtwald, Recipient of the McKinsey Award for his Harvard Business Review…
FDA Approves Fresenius Kabi, Formycon’s Stelara Biosimilar for Multiple Inflammatory Diseases
Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable…
The Challenges of Prescription Labeling for the Pharmaceutical Industry
Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when…
Merck Completes Acquisition of Investigational Bispecific Antibody Therapy from Curon Biopharmaceutical
CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or…
FDA Grants Priority Review to AstraZeneca’s Enhertu for HER2-Low or HER2-Ultralow Metastatic Breast Cancer
The application for Priority Review of Enhertu was supported by positive results from the DESTINY-Breast06 Phase…
Johnson & Johnson Expands Rollout of TECNIS Odyssey for Correcting Presbyopia
Designed for cataract patients, the TECNIS Odyssey aims to reduce the need for glasses by offering…
FDA Approves GE HealthCare’s Flyrcado for Diagnosing Coronary Artery Disease
Flyrcado is the first positron emission tomography myocardial perfusion imaging agent of its kind designed for…
Pharma Pulse 9/27/24: Coverage from LogiPharma USA 2024, Payers Looking for Change in Pharmacy Benefits & more
The latest news for pharma industry insiders.
AAM Names John A. Murphy as CEO
Murphy previously worked at the Biotechnology Innovation Organization as its chief policy officer.
RxPreferred Launches AI-Powered Savings Program for Members
The program, Rx-Performance, will be available starting in January of next year.
FDA Approves Bristol Myers Squibb’s Cobenfy for Schizophrenia
Landmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia…
FDA Approves Dupixent as First-Ever Biologic Treatment for Chronic Obstructive Pulmonary Disease
Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive…
What is the Secret Sauce for Top School Graduates to Convert Start-Up Ideas into Sustainable Firms?
A Harvard Business School Healthcare Alumni Association Q&A with Martin Gonzalez, Principal of Org and Leadership…
Study Suggests Semaglutide May Reduce Opioid Overdose Risk in Patients with Type 2 Diabetes
A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid…
Launch Lessons: Bringing a Targeted Oncology Therapy to Market
Omnichannel marketing can help companies improve HCP engagement to facilitate the delivery of effective treatment to…
Selecting & Developing a Mega Campus
In this part of his Pharmaceutical Executive video interview, Jonathan Scheinberg, of the Northeast Science and…
Securities Litigation Arising from Alzheimer's Drug Treatments
The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer’s…
FDA Approves Sarclisa for Certain Patients with Multiple Myeloma
The drug is approved for newly diagnosed patients not eligible for transplant and is to be…
Max Colao Shares How OncoVerity is Pioneering Oncology Solutions
Max Colao, CEO of OncoVerity, discusses his extensive experience in the biotech industry and shares how…
FDA Approves Bimzelx for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis…
Pharma Pulse 9/23/24: eSource EHR Requirements, Expanding Pharmacy Access & more
The latest news for pharma industry insiders.
Four Key Strategies for Optimizing Your Medical Congress Strategy
Conferences, congresses, and the digital discussions kicked off by those events create a halo effect that…
Global Real World Data Tour: 2024 Key Insights
Webinar Date/Time: Wednesday, October 9th, 2024 at 11am EDT | 8am PDT | 4pm BST |…
Bringing Marketing to a New Audience: Q&A with Jeremy Truxal
Truxal discusses Exact Science’s first Spanish language TV commercial and campaign for Cologuard.
Aflac Launches Campaign for Bridge to Brighter
The program is aimed at raising funds for children with cancer and blood disorders.
FDA Approves Rybrevant for Locally Advanced, Metastatic Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer
Rybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by…
Pharma Pulse 9/20/24: The Benefit to Adapting Operating Models, 50% of US Women Skip or Delay Medical Care & more
The latest news for pharma industry insiders.
Patritumab Deruxtecan Demonstrates Significant Survival Improvement in Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus…
Revelation Pharma Launches Nationwide Wholesale Service
The service will provide compounding pharmacy services to healthcare providers.
FDA Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis
Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of…
Keytruda Demonstrates Superior Overall Survival vs. Yervoy in Advanced Melanoma
Ten-year data from the Phase III KEYNOTE-006 trial found that Keytruda produced a 34% ten-year overall…
Pharmaceutical Executive: September 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive September 2024 issue in…
Pharma Pulse 9/17/24: Digital Solution Trends Heading into 2025, Misinformation vs Disinformation & more
The latest news for pharma industry insiders.
FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis
Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with…
Biopharma Must Transform its Payer Launch Playbook
The profitability of biopharma drug launches in the US will remain in decline until manufacturers reimagine…
Rx Power Struggle: How Pharma can Flip the PBM Script
The industry holds the key to true change to the drug access landscape.
FDA Approves Subcutaneous Tecentriq Hybreza for All Adult Indications of IV Form of Tecentriq
Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across…
Copay Adjustment Chess Match: What Will Payers Do Next?
As new litigation looms in the debate over use of copay accumulator programs, a look at…
Gilead's Lenacapavir Reduces HIV Infections by 96%, Surpassing Truvada in Twice-Yearly PrEP Treatment
Landmark results from the Phase III PURPOSE 2 trial found that lenacapavir demonstrated 89% greater efficacy…
A Risk-Reward Reset: Getting Serious About Social Media
As the digital medium poses new threats to brand equity and public safety for pharma, what…
Increasing Access to Legitimate Weight Loss Medications
In this part of their Pharmaceutical Executive video interview, UpScriptHealth’s Peter Ax, Founder and CEO, and…
Dupixent Demonstrates Reduced Symptoms of Chronic Spontaneous Urticaria
Dupixent displayed a nearly 50% reduction in itch and urticaria activity scores in patients with chronic…
How UpScriptHealth Guarantees Authenticity & Prevents Counterfeit Drugs from Entering Their Supply Chain
In this part of their Pharmaceutical Executive video interview, UpScriptHealth’s Peter Ax, Founder and CEO, and…
Report: Obesity Drug Market Estimated to be Worth $200 Billion by 2031
A recent study by Morningstar predicts that 16 new weight-loss drugs could be on the market…
WellSync Partners With Marius to Offer Oral TRT Treatment on Digital Platform
Users of the platform will have access to Kyzatrex.
Melissa Krebs Shares GelSana’s Vision for Innovative Wound Care Solutions
In this interview, Melissa Krebs, CEO and founder of GelSana, shares her journey in developing cutting-edge…
From Endemic to POC: The Journey Pharma Marketers Need to Tread
The digital revolution has brought more efficient ways to reach and touch HCPs.
FDA Approves Filspari for Adults with IgA Nephropathy
Filspari is considered the first non-immunosuppressive treatment to significantly slow kidney function decline in adults with…
Fenebrutinib Found Effective in Suppressing Relapsing Multiple Sclerosis Disease Activity
Results of the FENopta study found that after one year of treatment, 96% of patients experienced…
Beyond the Birthrate: The Societal Costs of Maternal Mortality
Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most…
Pharma Pulse 9/6/24: Gaps and Opportunities in Qualitative Systematic Reviews, Companies Grapple With Expanding Cyber Rules & more
The latest news for pharma industry insiders.
FDA Approves Boruzu for Subcutaneous, Intravenous Administration for Multiple Myeloma, Mantle Cell Lymphoma
Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment…
Potential Treatment Against All COVID Variants
Texas Biomed announced that research shows that a certain monoclonal antibody treatment could treat all variants…
Nucala Significantly Reduces Moderate to Severe Exasperations in Chronic Obstructive Pulmonary Disease
Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful…
Digital Protection: Q&A with Jeffrey Bernstein
Pharma companies are facing a higher number of incredibly destructive cyber-threats than ever before.
Efsitora Demonstrates Non-Inferiority vs. Insulin Glargine, Degludec for Type 2 Diabetes
Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C…
What is the Transformation Playbook for Moving From Digital Pilot to a Truly Scaled Production Solution?
A C-suite Q&A with Cristina Ortega Duran, President of Evinova.
High Dose Spinraza Significantly Improves Motor Function in Infants with Spinal Muscular Atrophy
Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at…
Moderna Launches New Campaign to Promote COVID Boosters
The “Do It For You & Them” campaign focuses on the impact that virus has on…
Lumryz Demonstrates Superiority Over Oxybate Treatments in Narcolepsy
Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate…
Understanding the Current State of M&A: Q&A with Cheryl Reicin
As the second half of 2024 begins, an industry expert discusses how mergers and acquisitions are…
Personify Health Offers Employers GLP-1s Best Practices for Coverage Options
The insurance company is offering the guidance in response to continued popularity of the drugs which…
Radiotherapies: Q&A with Thijs Spoor
Perspective Therapeutics’ CEO explains how this method can be used to determine how to target cancer…
Revitalizing Mature Pharma Brands: 5 Winning Strategies
Strategies that can help maintain and grow your market share. Plus how to adapt to new…
Pharma Pulse 8/30/24: Working Towards Greater Access and Diversity, Why 'Normalcy' Is Still a Crisis & more
The latest news for pharma industry insiders.
Ecolab Continues Mission to Protect What's Vital With Deep Investment in Life Sciences
Ecolab is looking to the future with new opportunities to partner with Pharma for critical solutions…
Sanyou Biopharmaceuticals Announces Line of Monkeypox Treatments
The product line includes vaccines, monoclonal antibodies, and antigens.
Johnson & Johnson Submits Biologics License Application for Nipocalimab in Patients with Antibody-Positive Generalized Myasthenia Gravis
Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined…
Roflumilast Cream Demonstrates Efficacy, Safety Treating Mild to Moderate Atopic Dermatitis in Children
Results of the INTEGUMENT-OLE study found that the roflumilast cream not only maintained but improved its…
FDA Grants Priority Review to Mirdametinib for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial,…
Leqvio Demonstrates Significant LDL-C Reduction in Patients at Risk of Atherosclerotic Cardiovascular Disease
Topline results from the Phase III V-MONO study of Leqvio found that twice-yearly Leqvio achieved clinically…
Research Growing into the Use of Psychedelics to Treat Substance Abuse
A new National Institutes of Health grant will advance research into the role of the serotonin…
Merck Launches Shorespan-007 Clinical Trial of Bomedemstat for Essential Thrombocythemia
Shorespan-007 is expected to enroll approximately 300 patients with essential thrombocythemia and will compare bomedemstat to…
Lilly Introduces Single-Dose Vials of Zepbound, Expanding Access for Adults with Obesity
The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50%…
FDA Approves Arthroscopic Delivery of Vericel’s MACI for Knee Cartilage Defects
The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects…
Dupixent Demonstrates Efficacy Treating Chronic Obstructive Pulmonary Disease, Asthma
Results from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations…
Pharma Pulse 8/23/24: Drug Coverage Changes in Medicare Part D Plans, Law That Shielded Big Tech Now Being Used Against It & more
The latest news for pharma industry insiders.
Unlocking the Potential of AI in Healthcare–5 Key Takeaways
The technology has the potential to be implemented across multiple aspects of the industry.
CDMOs are Exploring Risk-Sharing for Resilient Growth in a BANI World
Key industry trends and how the relationships between companies and CDMOs are evolving to better meet…
Addressing Challenges to Access, Advancement of Myeloma Therapies
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer,…
FDA Approves Updated COVID-19 Vaccines
The updated formulas should provide better protection against the currently circulating strains.
FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions
64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and…
Study Suggests Promise of Psilocybin in Treating Depressive Symptoms
Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms…
GLP-1 Therapy Significantly Increases Visceral Adipose Tissue Metabolic Activity in Patients with Obesity, Obstructive Sleep Apnea
Findings from a study published in the Journal of the Obesity Society may significantly advance the…
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma
Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial,…
FDA Grants Breakthrough Therapy Designation to GSK’s GSK5764227 for Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
Breakthrough therapy designation for GSK5764227 based on preliminary data from the ongoing ARTEMIS-001 Phase I trial,…
Johnson & Johnson Set to Acquire V-Wave Ltd
The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech,…
FDA Approves Johnson & Johnson’s Rybrevant and Lazcluze for Advanced Non-Small Cell Lung Cancer
Approval marks the first multitargeted regimen to surpass Tagrisso in efficacy in the first-line treatment of…
FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease
Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75%…
Sharing Failure to Find Success: Q&A with Katsuyoshi Sugita
Astellas Pharma’s chief people officer and chief ethics & compliance officer discusses the unique ways he’s…
'Marked’ for Stardom?: Truqap
A breakthrough for biomarker-altered breast cancer—but broader challenges remain.
Opening the Door: Omvoh
Key approval signals progress in addressing immune-mediated inflammatory diseases.
Divergent Paths: Pharm Exec Profiles Five Recent Drug Launches
Pharm Exec’s latest sampling of notable biopharma brand approvals and launches all have unique stories to…
An AI Pulse Check
Three pieces of coverage in this month’s issue of Pharmaceutical Executive explore the tipping point that’s…
Pharmaceutical Executive: July/August 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive July/August 2024 issue in…
A Promising Option: Exxua
Surviving a long road, novel next-generation treatment offers hope for major depressive disorder.
The Future of Launch Excellence is Generative AI
How drugmakers can reap value from using generative AI in their market-entry strategies and decision-making, including…
CVS Health Appoints New Chief People Officer
Heidi Capozzi previously served as chief people officer for McDonald’s.
Big Bets, Bold Steps
Ken Keller, CEO of Daiichi Sankyo’s US business, reflects on the trials, triumphs, and lessons learned…
Beyond the Buzz: Gauging the True Benefits of AI Today
It’s time to see where artificial intelligence is genuinely being utilized in pharma.
Thriving ‘Beyond the Pill’: Closing Key Gap in Patient Support
Why pharma needs to focus on improving—not just extending life.
AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses the Impact of PARP Inhibitors on Cancer Treatment
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical…
FDA Approves Ascendis Pharma’s Yorvipath as the First Treatment for Adults with Hypoparathyroidism
Yorvipath is designed to parathyroid hormone exposure over 24 hours in patients with hypoparathyroidism.
Pharma Pulse 8/9/24: AI Companies Fight to Stop California Safety Rules, Building Patient-centric Technology & more
The latest news for pharma industry insiders.
Finding the Trust in Clinical Trials: Q&A with Lisa Bailey
The Trinity Life Sciences managing director and head of DE&I strategy discusses recent research on the…
Merck to Acquire Investigational Bispecific Antibody for B-Cell Associated Diseases From Curon Biopharmaceutical
As part of the acquisition of CN201, Curon is expected to receive an upfront payment of…
FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis
Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to…
FDA Approves Citius Pharmaceuticals’ Lymphir for Relapsed or Refractory Cutaneous T-Cell Lymphoma
Lymphir is the first therapy to target the IL-2 receptor in the treatment of relapsed or…
FDA Grants Accelerated Approval to Novartis’ Fabhalta for Primary IgA Nephropathy
Accelerated approval of Fabhalta for treating primary IgA nephropathy was based on positive results from the…
Supportive Oncology Care Shows Promising Results for Patients' Quality of Life: Study
Independence Blue Cross and Jefferson health published a study detailing the impact of such care.
FDA Approves Medtronic’s Simplera Continuous Glucose Monitor, Announces Partnership with Abbott
Partnership with Abbott for Simplera CGM will expand access to the advanced automated insulin delivery.
FDA Approves Servier’s Voranigo for Grade 2 IDH-Mutant Glioma
Voranigo is the first targeted therapy in almost 25 years to be approved by the FDA…
The Impact of Lynparza as a Cancer Treatment
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical…
Pharma Pulse 8/6/24: The Evolution of Temperature-Sensitive Biologics, Is It Bad If AI Kills Meaningless Jobs? & more
The latest news for pharma industry insiders.
FDA Approves Expanded Indication for Octapharma’s Fibryga for Patients Experiencing Bleeding Due to Acquired Fibrinogen Deficiency
Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for…
Johnson & Johnson MedTech Launches Velys Active Robotic-Assisted System for Planning, Instrumenting Spinal Fusion Procedures
Velys recently received 510(k) clearance from the FDA for planning and instrumenting spinal fusion procedures across…
Informing Organon’s Strategic Approach From an OB-GYN POV
In this part of her Pharmaceutical Executive video interview, Charlotte Owens, MD, FACOG, Head of Medical…
Pharma Pulse 8/2/24: Poor Data is a Population Health Risk, Meta’s Earnings Calm AI Jitters & more
The latest news for pharma industry insiders.
Understanding IDNs and What They Mean to the Pharmaceutical Industry–Q&A with Greg Skalicky
Integrated Delivery Networks have impacted everything from drug launches to sales approaches.
FDA Expands Approval of GSK’s Jemperli in Combination with Chemotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer
Approval marks the first time an immuno-oncology regimen has demonstrated a survival benefit for all adults…
FDA Grants Accelerated Approval to Adaptimmune Therapeutics’ Tecelra for Adults with Synovial Sarcoma Who Have Undergone Prior Chemotherapy
Regulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the…
Blue Shield of California Offers Blue Zones Challenge App to Members
The app provides users with lifestyle tips and plans based on the lifestyles of people living…
Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer
IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small…
AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses 10 Years of Lynparza Across Eight Indications
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical…
Data Show Three Years of Continuous Treatment with Leqembi Reduces Cognitive Decline in Patients with Early Alzheimer Disease
Results of the Phase III Clarity AD study found that Leqembi reduced cognitive decline by -0.95…
Women’s Healthcare: Will Changing Laws Inhibit Latest Innovations in Fertility and Birth Control Treatments?
With a growing number of legal battles over women’s health issues, such as abortion and infertility,…
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder
Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval…
AvaSure Acquires Ouva and Adds Smart Room Solutions to its Platform
Ouva’s AI-powered technology will be added to AvaSure’s digital platform.
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease
Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve…
Pharma Pulse 7/29/24: Why the Multimodal Data is Growing in Pharma, Specialty Drug Trend Continues Upward & more
The latest news for pharma industry insiders.
Giroctocogene Fitelparvovec Demonstrates Superiority over Factor VIII Prophylaxis in Reducing Annual Bleeding Rate in Patients with Moderate to Severe Hemophilia A
A single dose of giroctocogene fitelparvovec significantly reduced the mean total annual bleeding rate in patients…
Fighting the Drop in Vaccination Rates: Q&A with Gregg Sylvester
An unexpected consequence of the COVID 19 pandemic has been a loss in trust of vaccines.…
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…
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…
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…
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…
Integrity Partners With Gosen Insurance Group to Bring New Solutions to Hispanic Communities in Florida
The partnership will allow both group to expand their operations and provide more solutions to underserved…
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…
Pharma Pulse 7/24/24: Now is Not the Time to End the Global AIDS Effort, Preparing for the Next Worldwide Tech Outage & more
The latest news for pharma industry insiders.
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…
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…
Fitterfly Announces Home Digital Therapeutic That Uses AI to Analyze Images of Meals
The AI-powered feature will provide detailed nutritional information based on photos of food taken by users.