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.
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…
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.
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.
Financial Times Global Pharma and Biotech Summit: The Impact of the Election
How will President Trump’s return to office impact the pharma industry?
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.
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.
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.
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.
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.
Pharma Pulse 11/4/24: Community Pharmacies in Crisis, Insights Into ADHD Diagnoses in Adult Women & more
The latest news for pharma industry insiders.
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.
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…
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.
Pharma Pulse 11/1/24: Navigating Diversity and Digital Innovation, Key Clinical Information on Infertility & more
The latest news for pharma industry insiders.
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.
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.
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.
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.
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.
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.
FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly Diagnosed Chromosome-Positive Chronic Myeloid Leukemia
Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix’s superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia…
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.
GSK Agrees to Terms to Acquire Novel Treatment for Autoimmune Diseases from Chimagen Biosciences
CMG1A46 is currently being developed for B cell-driven autoimmune diseases, primarily systemic lupus erythematosus and lupus nephritis.
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.
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.
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.
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…
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 with potential future development, regulatory, and commercialization milestones.
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.
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…
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 future of gene therapy as part of the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
Qnovia CEO to Speak at Public Meeting with FDA and NIH
The meeting is set to focus on advancing smoking cessation.
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.
FDA Expands Indication of Alvotech and Teva’s Stelara Biosimilar
The expanded indication of Selarsdi for the treatment of diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease is expected to support the official launch early next year.
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 Pharmaceutical Executive Advisory Board Member discusses how personalized audio will be utilized within the pharma marketing industry in 2025.
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…
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 impacted by the recent storms.
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.
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.
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 to destroy cancer cells with minimal damage to healthy tissue.
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.
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.
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.
‘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.
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.
Amwins Expands Gene Therapy Coverage
The program will now cover 15 gene and cell therapies.
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.
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 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.
How to Rally a Team Around Building a New Business
Three key components to scaling quickly—while maintaining purpose.
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.
The Role of Digital Passports in Preventing Off-Label Usage
Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways that digital passports can help ensure patients receive the correct medication.
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 in kidney transplant recipients compared with placebo.
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.
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.
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.
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.
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 significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.
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.
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 manufacturing, with Sun Pharma leading global commercialization.
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 efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.
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 it comes to proper drug labeling.
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 refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.
sa-mRNA COVID-19 Vaccine Study Demonstrates Longer Protection Against Virus Compared to Other Vaccine Types
CSL and Artcurus announced the results of a study on the self-amplifying RNA vaccine.
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.
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 Development at Google.
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 in decades.
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 pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.
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 drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.
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 used in combination with standard-of-care treatment.
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 his company is harnessing computational biology and machine learning to develop personalized cancer treatments that aim to reshape the future of oncology care.
Pharma Pulse 9/23/24: eSource EHR Requirements, Expanding Pharmacy Access & more
The latest news for pharma industry insiders.
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 that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.
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 amplifies scientific information more so than other scientific activities.
Global Real World Data Tour: 2024 Key Insights
Webinar Date/Time: Wednesday, October 9th, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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.
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.
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 more than 50% in patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer, according to Johnson & Johnson.
Revelation Pharma Launches Nationwide Wholesale Service
The service will provide compounding pharmacy services to healthcare providers.
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 pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
FDA Approves Keytruda Plus Pemetrexed, Platinum Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when Keytruda was added to chemotherapy in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
FDA Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis
Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.
A Care Sea Change
This month is as good a time as any to take a deep look at the transformations taking place in point-of-care delivery.
Pharmaceutical Executive: September 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive September 2024 issue in an interactive PDF format.
Delivery and Disruption: Navigating a Changing Care Terrain
The diversification of site-of-care delivery models is accelerating rapidly, creating new go-to-market implications for drug manufacturers—but also new opportunities to drive more fundamental innovation in engagement and access strategies.
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 Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.
CVS Pharmacies to Offer Birth Control Prescribing Services in Massachusetts
These services will help alleviate the impact of contraceptive deserts in the state.
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 approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.
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 potential next moves for payers—and steps drug manufacturers should take to ward off cost-driven non-adherence.
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 than Truvada in preventing HIV infections.
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 can drugmakers do to better balance its essential communications benefits with the risks?
FDA Approves Tremfya for Moderately to Severely Active Ulcerative Colitis
Tremfya is the first and only fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64 to be approved for the treatment of moderately to severely active ulcerative colitis.
Dupixent Demonstrates Reduced Symptoms of Chronic Spontaneous Urticaria
Dupixent displayed a nearly 50% reduction in itch and urticaria activity scores in patients with chronic spontaneous urticaria.
Making the Leap from Pharmaceuticals to Private Equity, Venture Capital
A Harvard Business School Healthcare Alumni Association Q&A with Jeremy Goldberg of Arsenal Capital Partners.
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 by 2029.
Zongertinib Demonstrates High Objective Response Rate in Previously Treated Advanced Non-Small Cell Lung Cancer
Results from the Phase Ib Beamion LUNG-1 trial found that zongertinib achieved an objective response rate of 66.7% in previously treated patients with advanced non-small cell lung cancer with HER2 mutations.
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 biomaterials that could transform the $78 billion wound care market.
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 no relapses of multiple sclerosis, with an annualized relapse rate of just 0.04.
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 IgA nephropathy.
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 critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
Digital Protection: Q&A with Jeffrey Bernstein
Pharma companies are facing a higher number of incredibly destructive cyber-threats than ever before.
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 of multiple myeloma and mantle cell lymphoma.
Potential Treatment Against All COVID Variants
Texas Biomed announced that research shows that a certain monoclonal antibody treatment could treat all variants of COVID-19, including past, present, and future strains.
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 reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.
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.
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 levels using once-weekly efsitora compared to daily insulin glargine and degludec.
Kerendia Reduces Cardiovascular Deaths in Patients with Cardio-Kidney-Metabolic Conditions
Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.
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 six months in infants with spinal muscular atrophy.
Camzyos Demonstrates Efficacy, Safety Treating Symptomatic Obstructive Hypertrophic Cardiomyopathy
Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5 years of treatment.
Lumryz Demonstrates Superiority Over Oxybate Treatments in Narcolepsy
Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.
Radiotherapies: Q&A with Thijs Spoor
Perspective Therapeutics’ CEO explains how this method can be used to determine how to target cancer cells without damaging other organs.
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 are commonly used for weight-loss management.
Embracing FSPs: Q&A with Jenny Denney
Pharmaceutical companies are seeing the benefits of being able to outsource entire functions through functional service providers.
Revitalizing Mature Pharma Brands: 5 Winning Strategies
Strategies that can help maintain and grow your market share. Plus how to adapt to new competitive pressures and evolving customer needs.
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 to support drug development and manufacturing.
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 with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.
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 efficacy over time treating children from two to five years of age with mild to moderate atopic dermatitis.
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, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.
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 LDL-C lowering compared to both placebo and ezetimibe.
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 5-HT2A receptor in mitigating methamphetamine use.
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% lower than other incretin medications for obesity.
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 hydroxyurea, the current standard of care.
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 by 31% over 52 weeks.
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 in the knee.
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 the challenges of a BANI world.
Addressing Challenges to Access, Advancement of Myeloma Therapies
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.
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 a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.
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 compared to both placebo and escitalopram in patients with major depressive disorder.
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 understanding of GLP-1 analogues and their role in treating obesity.
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, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.
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, which showed the novel therapy’s promise treating patients with relapsed or refractory extensive-stage small-cell lung cancer.
Johnson & Johnson Set to Acquire V-Wave Ltd
The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.
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 advanced non-small cell lung cancer, according to Johnson & Johnson.
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% response rate in patients with chronic graft-versus-host disease.
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 brought DE&I to the workplace.
'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.
A Promising Option: Exxua
Surviving a long road, novel next-generation treatment offers hope for major depressive disorder.
An AI Pulse Check
Three pieces of coverage in this month’s issue of Pharmaceutical Executive explore the tipping point that’s seemingly on the cusp in artificial intelligence.
Pharmaceutical Executive: July/August 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive July/August 2024 issue in an interactive PDF format.
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 tell—from the winding journeys to innovative “firsts” to new momentum for milestones to come.
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 mitigating launch challenges and enhancing the customer conversation.
CVS Health Appoints New Chief People Officer
Heidi Capozzi previously served as chief people officer for McDonald’s.
Beyond the Buzz: Gauging the True Benefits of AI Today
It’s time to see where artificial intelligence is genuinely being utilized in pharma.
Big Bets, Bold Steps
Ken Keller, CEO of Daiichi Sankyo’s US business, reflects on the trials, triumphs, and lessons learned in steering the transformation of a legacy cardiovascular company into a global leader in oncology—advancing a vision for a reimagined future in cancer treatment.
Thriving ‘Beyond the Pill’: Closing Key Gap in Patient Support
Why pharma needs to focus on improving—not just extending life.
Asia Embracing New Technologies for Better Healthcare
The region is moving to the forefront in integrating therapeutic innovation.
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 Affairs, US Oncology Business Unit, AstraZeneca, talks PARP inhibitors in cancer treatment and the history of Lynparza.
FDA Issues Complete Response Letter to Lykos Therapeutics for Midomafetamine Capsules in the Treatment of Post-Traumatic Stress Disorder
The Complete Response Letter stated that current data on midomafetamine capsules is insufficient for approval in treating patients with post-traumatic stress disorder.
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 topic.
Could the Jobs Report Help Reverse Biotech’s Underperformance?
The data may be a catalyst for sector with a now-likely rate pivot looming.
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 $700 million, with the opportunity to earn an additional $600 million in milestone payments linked to the drug’s development and regulatory approval.
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 traditional needle injections.
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 refractory cutaneous T-cell lymphoma and the first FDA-approved product for Citius Pharmaceuticals.
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 Phase III APPLAUSE-IgAN study.
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 for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery.
The Impact of Lynparza as a Cancer Treatment
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical affairs, US oncology business unit, AstraZeneca, provides an update on current research efforts for Lynparza and discusses its impact on cancer patients over the…
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 this indication.
FDA Grants De Novo Marketing Authorization to Labcorp’s Genomic Testing Kit
The PGDx elio plasma focus Dx offers laboratories testing options for situations where samples are hard to obtain.
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 Affairs and Outcomes Research at Organon, discusses how she’s using her in-practice experience as an OB-GYN to inform Organon’s strategic approach to addressing maternal…
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 with primary advanced or recurrent endometrial cancer, company says.
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 United States.
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 in regions with the highest lifespans.
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 cell lung cancer.
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 affairs, US oncology business unit, offers his thoughts on the evolution of Lynparza across indications such as breast, prostate, and pancreatic cancers.
Data Show Three Years of Continuous Treatment with Leqembi Reduces Cognitive Decline in Patients with Early Alzheimer Disease
Results of the Phase III Clarity AD study found that Leqembi reduced cognitive decline by -0.95 on the Clinical Dementia Rating-Sum of Boxes compared to expected declines in untreated groups.
Women’s Healthcare: Will Changing Laws Inhibit Latest Innovations in Fertility and Birth Control Treatments?
With a growing number of legal battles over women’s health issues, such as abortion and infertility, stakeholders are concerned about the impact on everything from healthcare access to new technology.
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder
Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says.
AvaSure Acquires Ouva and Adds Smart Room Solutions to its Platform
Ouva’s AI-powered technology will be added to AvaSure’s digital platform.
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease
Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.
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.
Fighting the Drop in Vaccination Rates: Q&A with Gregg Sylvester
An unexpected consequence of the COVID 19 pandemic has been a loss in trust of vaccines. Over the past three flu seasons, there has been a drop in vaccination rates that is alarming experts. Dr. Gregg Sylvester, chief health officer…