Global Launch Strategies in the Current Political Climate
James Foster, CEO and co-founder of Virax Biolabs, discusses how global launches are being impacted by changing geopolitical conditions.
FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk
Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in multiple myeloma and solid tumor bone metastases.
Navigating Distrust: Pharma in the Age of Social Media
Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will impact industry marketing strategies and the relationships between pharmaceutical companies and the patients they aim to serve. He also explains dark social, how to…
FDA Approves Sanofi’s Rapid Acting Insulin Biosimilar Merilog for Diabetes
Meilog marks the first rapid-acting insulin biosimilar to gain FDA approval for the treatment of diabetes.
Pharmaceutical Executive: February 2025 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive February 2025 issue in an interactive PDF format.
Limitations of Modern Databases: Q&A with Stavros Papadopoulos
The TileDB CEO discusses how the life sciences can overcome these limitations.
Preparing for Potential Vaccine Regulatory Changes
James Foster, CEO and co-founder of Virax Biolabs, discusses how the industry is preparing for potential regulatory changes to vaccine policy.
FDA Approves Pfizer’s Adcetris for Relapsed or Refractory Large B-Cell Lymphoma
Approval of Adcetris provides a new treatment option for patients with relapsed or refractory large b-cell lymphoma who are ineligible for autologous stem cell transplantation.
Navigating an Uncertain Regulatory Landscape
James Foster, CEO and co-founder of Virax Biolabs, discusses how companies can strategize despite hard-to-predict regulatory headwinds.
Q&A: Gain Therapeutics CEO Discusses AI-Driven Drug Discovery, Strategic Growth Plans
Gene Mack, Gain Therapeutics CEO, provides a look into the future of the company and the use of physics-based artificial intelligence in the drug discovery process.
Proactive Engagement: How AI-Driven Alerts are Transforming HCP Outreach
The benefits for brand teams in bolstering their rapid-response capability.
The Shifting Pharmacy Landscape in 2025
Polypharmacy, biosimilars, and GLP-1s among the evolving trends likely to play out in the pharmacy benefits space.
Biopharma Business Check: Financing Review and Outlook
A look at the M&A and stock market pictures for full-year 2024—and the potential strategic implications for pharma and biotech ahead.
Statistically and Clinically Significant Paths to Value Proposition
Demonstrating clinical benefit is the ultimate gateway to smoother patient access.
Slideshow: PwC Report Identifies Top Trends in Pharma
PwC report identifies transformative trends impacting the pharma market this year and into the future.
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.
The Teva Turnaround: Steering a Company Comeback
CEO Richard Francis reflects on Teva’s return to growth during his tenure, and what’s next for the drugmaker in its quest to recapture the heights of old.
Revolutionizing Patient Adherence: Leveraging AI for Personalized Engagement
Bill Grambley, CEO of AllazoHealth, delves into the potential of AI to revolutionize patient engagement and adherence.
Mim8 Demonstrates Promising Results in Pediatric Patients with Hemophilia A
Data from the Phase III FRONTIER3 trial found that 98% of caregivers prefer Mim8 for hemophilia A over other treatments.
Pharma Pulse 2/7/25: SCOPE Summit 2025 Coverage, Genetic Sensitivity to Stress Possibly Links to Lung Cancer & more
The latest news for pharma industry insiders.
AI Drug Discovery Impact on Pharmaceutical Value Chain
In this Pharmaceutical Executive video interview, Edoardo Madussi, Head of Business Development, Intelligencia AI discusses where else the the pharmaceutical value chain may be impacted by LLMs.
Finding Underserved Communities: Q&A with Biljana Naumovic of J&J
Biljana Naumovic discusses the importance of finding ways to reach out to underserved communites.
Pfizer Appoints Jeffrey Legos as Chief Oncology Officer
Legos will take over from Roger Dansey, who will begin transitioning to retirement.
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.
Preventing Silos During Product Launches: Q&A with Dan Rizzo
New technology is creating new opportunities but is also causing new complications.
Merck Launches Phase III Trial Evaluating Zilovertamab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
The waveLINE-010 trial will compare zilovertamab vedotin, in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone against the current standard-of-care in patients with previously untreated diffuse large B-cell lymphoma.
AMCP Issues Statement on Tariffs’ Potential Impact on Pharmaceutical Industry
Susan Cantrell responds to the tariffs on China, Canada, and Mexico.
Overall Impact of AI-Driven Discovery Platforms
In this Pharmaceutical Executive video interview, Edoardo Madussi, Head of Business Development, Intelligencia AI compares and discusses the potential impact of AI-driven drug discovery platforms.
FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus
The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for refractory systemic lupus erythematosus with extrarenal involvement, marking the second such designation in autoimmune diseases.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
Pharma Pulse 2/4/25: Analyzing Supply Chain Complexities, Navigating Medicare Advantage in 2025 & more
The latest news for pharma industry insiders.
Pharma Organizations Respond to Proposed Tariffs
President Trump’s tariffs will include imported pharmaceuticals, among other items that will impact the industry.
Pharma Pulse 2/3/25: The Rundown on Rebates, GLP-1s and Pharmacists' Role & more
The latest news for pharma industry insiders.
Senior Senators Introduce Bill to Force DTC Drug Advertisements to Include List Price
Senators Durbin and Grassley proposed the new regulations for direct-to-consumer pharma advertising.
2025 Pharma Forecast: Four Pivotal Trends Revolutionizing Market Access Strategies
2025 Pharma Forecast: Four Pivotal Trends Revolutionizing Market Access Strategies
FDA Approves Vertex Pharmaceuticals’ First-in-Class Non-Opioid Journavx for Moderate-to-Severe Acute Pain
Approval of Journavx for acute pain marks the first new class of acute pain medication approved by the FDA in over 20 years.
FDA Approves Axsome Therapeutics’ Symbravo for Migraine with or without Aura
Clinical trials demonstrated that a single dose of Symbravo provides rapid migraine relief, sustains efficacy for up to 48 hours, and reduces the need for rescue medication.
IMU-856 Shows Promise in Celiac Disease: Histologic Protection and Nutrient Absorption Key to Advancing Trials
Daniel Vitt, CEO, Immunic Therapeutics, discusses promising results from the Phase Ib trial of IMU-856 in celiac disease.
Why Frontline Sales Have and Will Continue to be a Foundation for Long-term Career Success
A Harvard Business School Healthcare Alumni Association Q&A with Paul Ollinger, one of Facebook’s first 250 employees.
Roundup: Top Pharma Companies Report Q4 Earnings, Highlighting Revenue Trends and Market Shifts
Q4 earnings for companies such as Johnson & Johnson, Teva, and Roche highlight the impact of significant innovations brought to market last year.
Spravato’s Transformative Impact: Offering Hope and Rapid Relief for Patients with Depression
Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the immediate impact Spravato has had on patients with treatment-resistant depression.
ADRIATIC Trial Demonstrates Significant Survival Benefit in LS-SCLC, Potentially Shaping Future Treatment Standards
Nancy Ghattas, VP, US franchise head, imunno-oncology, gastrointestinal tumors, AstraZeneca, discusses the promising results from the ADRIATIC trial, in which patients were treated with Imfinzi for limited-stage small cell lung cancer.
Pharma Pulse 1/29/25: A Closer Look Into the Role of Compounding Pharmacies, Emerging Therapies for PPF & more
The latest news for pharma industry insiders.
New Spravato Indication Offers Greater Flexibility and Personalization for Patients with Treatment-Resistant Depression
Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the approval of Spravato for treatment-resistant depression.
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and clinical studies and managing chemistry, manufacturing, and controls (CMC) activities.
EMA Takes Break From X, Joins Bluesky
The government agency says X no longer suits its communication needs.
The Ups and Downs of AI for Pharma Investors
Ash Shehata from KPMG discusses how artificial technology has a lot to prove, although investors still see a lot of potential in it.
Viralgen and Axovia Partner to Manufacture Gene Therapy for Retinal Dystrophy in Bardet-Biedl Syndrome Patients
New partnership hopes to give BSS patients more options for treatment.
Pharma Pulse 1/24/25: Clinical Technology Advancements, Encourage Patient Accountability & more
The latest news for pharma industry insiders.
Using Digital Therapeutics with Abuse-Deterrent Pain Medication
Paul Howe, chief commercial officer at Protega, discusses efforts to combine high tech solutions with pain-management medications.
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.
AbbVie, Neomorph Strike Deal to Co-Develop Molecular Glue Degraders for Oncology, Immunology
Under terms of the deal, AbbVie will provide Neomorph with an upfront payment and the potential to earn up to $1.64 billion in milestone payments.
Jelmyto Demonstrates Significant Recurrence-Free Survival Rate at Three Years in Patients with Low-Grade Upper Tract Urothelial Cancer
Trial findings show long-term recurrence-free survival in patients with low-grade upper tract urothelial cancer treated with Jelmyto.
FDA Approves Two Generics from Amneal Pharmaceuticals for Alzheimer and Oncology, with Tentative Approval for Gastrointestinal Disease
As part of the regulatory action, memantine/donepezil extended-release capsules have been granted a 180-day exclusivity in patients with Alzheimer disease, with Everolimus receiving approval for tuberous sclerosis complex.
FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections
The cobas liat test aims to improve patient outcomes by offering rapid, accurate results in decentralized and community-based settings for patients at risk for chlamydia, gonorrhea, and Mycoplasma genitalium.
Sen-Jam Partners Strikes Deal with 5 Horizons Capital to Support Phase II Trial of SJP-001 for Inflammation, Metabolic Health
The trial, developed in collaboration with Novotech, will specifically target dietary and alcohol-induced overindulgence.
AD04 Advancing to Phase III Amid Promising Results in Alcohol Use Disorder
Cary Claiborne, CEO, Adial Pharmaceuticals, discusses AD04’s development timeline and next steps towards approval for alcohol use disorder.
Novel GLP-1 Receptor Agonist Demonstrates Promising Results Treating Patients with Obesity
Data from a Phase Ia single ascending dose study found that ASC30 demonstrated dose-proportional pharmacokinetics, a half-life of up to 60 hours, and superior pharmacokinetic properties compared to other oral GLP-1 receptor agonists.
FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer
Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated, unresectable, or metastatic HR-positive, HER2-negative breast cancer.
JPM25: Oncology Outlook for 2025
Panel participants share an optimistic outlook for integrating new innovations, tacking community-level challenges, and more.
AD04-13 Study Highlights Consistent Bioavailability and Safety for Alcohol Use Disorder Treatment
Cary Claiborne, CEO, Adial Pharmaceuticals, discusses promising results of the AD04-13 study in patients with Alcohol Use Disorder
Pharma Pulse 1/17/25: Compounding Pharmacies and Meeting Patient Needs, Survey Shows Gaps in Consumer Awareness & more
The latest news for pharma industry insiders.
Casey McPherson Shares His Journey With Rare Drug Development and Chrysalis Genetics
Casey McPherson, Founder and CEO of Chrysalis Genetics, talks about his daughter’s rare genetic condition, and how it led him to antisense oligonucleotides (ASOs) and therapeutic development for rare diseases.
HHS Selects 15 New Drugs for Medicare Part D Price Negotiations
As part of the Inflation Reduction Act, price negotiations with manufacturers will begin this year, with reduced prices expected to take effect in 2027.
FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.
The Bottlenecks Blocking Cell and Gene Therapy
Jason Foster, CEO of Ori Biotech, discusses the difficulties preventing more widespread adoption of these advanced therapies.
FDA Approves Incyte and Syndax’s Niktimvo for Chronic Graft-Versus-Host Disease in 9 and 22 mg Vial Sizes
Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host disease.
Cigna Expands Access to Fertility and Family-Building Benefits
A new offering in collaboration with Progyny, Inc makes fertility/family-building services more accessible and equitable.
Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.
NVIDIA Announces Pharma Partnerships to Expand AI
The company revealed plans to increase the usage of AI in pharma at JP Morgan’s healthcare conference in San Francisco.
Partnering for Progress: Leveraging Advocacy Groups to Drive Awareness and Participation in IPF Trials
John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials for idiopathic pulmonary fibrosis.
Pharma Pulse 1/14/25: Simpler Sample Ordering for HCPs, Smart Money Bets on Value & more
The latest news for pharma industry insiders.
Flurry of Acquisitions and Licensing Deals Come Amid JP Morgan Healthcare Conference 2025
Organizations including Gilead, Eli Lilly, and AbbVie announced a number of deals addressing inflammatory diseases, multiple myeloma, and other disease areas.
Pharma Pulse 1/13/25: The Path to Improve DEI in Clinical Trials, AI Improves Breast Cancer Screening/Detection & more
The latest news for pharma industry insiders.
Bausch + Lomb Launches Second Annual Faces of Glaucoma Campaign
The campaign will include patient stories, education resources, and is being held in partnership with the Glaucoma Research Foundation.
Havas Launches GLP-1 Focused Content Platform
‘Shape Shifting’ is a creator-led series that focuses on the scientific and cultural impact of GLP-1s.
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Generalized Myasthenia Gravis
Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.
Additional Security Measures Taken for J.P. Morgan Healthcare Conference
San Francisco Police cancel time off requests to increase security at the J.P. Morgan Healthcare Conference after the recent murder of UnitedHealth Group CEO Brian Thompson.
Blue Shield of California Issues Statement Regarding California Wildfires
Company leadership urged members and employees to stay safe and follow evacuation orders.
Amylyx Names New Chief Commercial Officer Ahead of GLP-1 Commercialization
Dan Monahan will serve in the role as the drug goes through Phase III trials.
FDA Mandates Updates to Prescribing Information for RSV Vaccines Abrysvo, Arexvy for Increased Guillain-Barré Syndrome Risk
Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.
FleishmanHillard Expands Health and Life Sciences Global Leadership Team
Mary Kosinski joined the firm as global managing director for the sector, along with other leadership additions.
Swoop Acquires MyHealthTeam
This acquisition will help generate data from over four million members of MyHealthTeams’ opted-in patient universe.
Future-Proofing CRM Investments in Life Sciences: Observations from Dreamforce 2024
The future is bright with AI-powered innovations, but migration presents significant risks, including data loss, increased costs, and disruption to business operations.
FDA Grants Fast Track Designation to Vergent Bioscience’s Novel Agent for Visualizing Solid Tumors During Lung Cancer Surgeries
Fast Track designation was based on results from a Phase II study, which demonstrated that VGT-309 was safe, well-tolerated, and enhanced tumor visualization in lung cancer patients.
Artificial Intelligence Makes Possible a Multiomic Approach in Oncology Drug Discovery
While challenges remain, AI is accelerating the process by enabling researchers to identify and design new drug candidates more quickly and efficiently with applications in target discovery, structure prediction, and drug optimization.
FDA Issues New Recommendations for Use of Artificial Intelligence to Support Regulatory Actions
Guidance marks the regulatory body’s first on artificial intelligence applications in drug and biological product development.
Monitoring the Safety of WHISTLE-PF in IPF Across Diverse Populations
John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment’s safety profile.
Zepbound Expected to Surpass Wegovy in Weight Loss Market, New Report States
GlobalData’s new findings show that the Zepbound may become the top WLM in the coming year.
As Healthcare and Technology Intersect, Why Are Strong Communication Skills Crucial for Today and Tomorrow?
A Q&A with Harvard’s Laura Wegner, serial entrepreneur and Rhodes Scholar-elect.
Sanofi, SK Bioscience Launch Phase III Trial Program to Develop PCV21 for Pneumococcal Conjugate Vaccines
PCV21 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a Phase III clinical trial in infants and toddlers.
Johnson & Johnson, Kaken Pharmaceutical Strike Licensing Agreement for the STAT6 Program That Targets Autoimmune, Allergic Diseases
Under terms of the deal, Johnson & Johnson will gain an exclusive license to the STAT6 program, with Kaken maintaining commercialization rights in Japan.
Biotech in the Empire State: Building a World-Class Bioscience Ecosystem in New York
Jennifer Hawks Bland, CEO of NewYorkBIO, shares her journey from litigation to biotech leadership, discusses fostering innovation in New York’s thriving bioscience ecosystem, and outlines her vision for the state as a global biotech hub.
Pharma Pulse 1/3/25: Physician Engagement and Tackling Health-Related Social Needs, Can Pain Be Patched Up? & more
The latest news for pharma industry insiders.
FDA Approves BeiGene’s Tevimbra for Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma
Approval of Tevimbra was supported by the RATIONALE-305 Phase III trial, which demonstrated a significant overall survival benefit in patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
How Pharma’s Checks and Balances Can Help Fight Its Public Perception
What can we do to prevent such blatant black eyes to the industry so many of us love?
2024’s Biggest Weight Loss Drug Stories
GLP-1s continue to dominate the market, but can pharma keep up with the demand?
Beyond IVF: The Next Generation of Fertility Solutions
In this Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), speaks about exciting developments in fertility treatment that he anticipates in the next few years.
2024’s Biggest Marketing Stories
Point of care messaging and AI resulted in more targeted campaigns over the past year.
Leveraging Technology and Data for Personalized Fertility Treatment
In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), talks about advancements in technology and data analysis that could lead to more personalized fertility treatments.
Non-Surgical Approaches to Diagnosing Endometriosis
In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), how new radiological techniques are revolutionizing the diagnosis of conditions like endometriosis and the impact it will have on…
Our Top 5 Social Media Posts of 2024
Check out our top five most engaged social media posts from the year 2024.
The Power of AI: Personalized Medicine and Predictive Analytics
In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, shares some specific examples of how AI is being used to personalize treatment plans, monitor patient progress, and identify potential issues.
2024’s Executive Profiles
Pharm Exec covered key players in the industry over the past year.
Navigating Fertility Misinformation on Social Media
In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), discusses the biggest misconceptions about fertility that he sees circulating on social media and work he does to correct…
The Ethical Implications of Sharing Personal & Professional Experiences on Social Media
In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), explains the ethical considerations of using social media to share personal and professional experiences, especially in a field as…
Making an Impact in the Era of Disinformation
With increasing cases of disinformation across social media blurring the lines of what’s credible and real, how can pharma break through the noise and build back public trust?
2024’s Top DTC Stories
New technologies are creating more efficient ways for pharma companies to work directly with consumers.
The Affects of ENV-101 on IPF
John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.
Our Top 5 Podcast Episodes of 2024
The top five episodes of our podcast in the year 2024, highlighted.
The Impact of Regulatory Policy on Telehealth Innovation
In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses regulatory challenges and opportunities that telehealth companies face in 2025.
Pharma Pulse 12/24/24: Forecasting the 2025 Healthcare Logistics Space, Tech Industry on Cusp of AI Slowdow? & more
The latest news for pharma industry insiders.
FDA Approves Hikma’s Generic GLP-1 Agonist for Type 2 Diabetes
Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes, alongside diet and exercise.
FDA Grants Accelerated Approval to Pfizer’s Braftovi Combination for Metastatic Colorectal Cancer
Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.
FDA Approves Ionis Pharmaceuticals’ Tryngolza for Familial Chylomicronemia Syndrome
Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.
Merck Obtains Global License for Hansoh’s HS-10535
The molecule is an investigational pre-clinical oral GLP-1 receptor agonist.
Pharma Pulse 12/20/24: Trends in Enterprise Value Growth and Value-to-Sales Ratios, PPF, Its Risk Factors & more
The latest news for pharma industry insiders.
Peer Exchange: AI’s Data Advantage
In the third part of this roundtable discussion, experts discuss the issues with data that AI must overcome.
The Impact of DEA Telehealth Extensions on Patient Access
In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses the recent DEA extensions of telehealth for controlled substances and new treatment modalities or patient populations he anticipates will become more accessible through telehealth in…
Pharma Marketing's Top Movers and Shakers in 2024
These professionals in the healthcare marketing sector have been chosen by their peers for making big moves and taking on larger roles.
The Transformative Potential of AI in the Pharmaceutical Industry: Opportunities and Cautions
The technology provides the industry with many opportunities, but it must also navigate a complex regulatory landscape.
Shuttle Pharmaceuticals, UCFS Strike Sponsored Research Agreement
Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of prostate cancer.
FDA Updates Guidelines on Compounding Tirzepatide Injections as GLP-1 Shortage Ends
Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing, or dispensing of compounded tirzepatide injections to end within 90 days.
FDA Approves Celltrion’s Stelara Biosimilar for Multiple Indications
Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.
FDA Grants Breakthrough Therapy Designation to Gilead’s Trodelvy for Extensive-Stage Small Cell Lung Cancer
Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive extensive-stage small cell lung cancer.
Pharma’s ‘Best-Kept Secret’
Margaret Keegan, the new CEO of Precision Medicine Group, is eager to elevate the profile of the expert-rich service provider and build it into an industry leader in next-gen drug development and commercialization support.
Seeking More Value, Less Cost
The biosimilars market in the US is on the rise, but barriers to greater adoption remain.
FDA Grants Breakthrough Therapy Designation to GSK’s Jemperli for Locally Advanced Mismatch Repair Deficient/Microsatellite Instability-High Rectal Cancer
The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a 100% clinical complete response rate in patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.
A Rocky Road for Regulation
With the Inflation Reduction Act now in flux, how will the government and industry respond?
Introducing Agentic AI: Its Revolutionary Potential in Pharma
A look at the promise and opportunities from this new and advanced type of AI in transforming commercial planning and execution for life sciences companies.
FDA Grants Breakthrough Therapy Designation to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis
The regulatory action was supported by results from the Phase III HERCULES trial, which demonstrated a 31% reduction in six-month confirmed disability progression in non-relapsing secondary progressive multiple sclerosis.
Pharmaceutical Marketing Challenges & Trends to Expect on 2025: According to KOLs
Industry voices stress importance of a strategic approach to social media marketing, choosing platforms wisely, prioritize privacy, leveraging targeted advertising techniques and more.
Pharma Forecasting: Key Markets Investors Can’t Ignore
The importance of expanding your pharma sales forecasting horizon beyond the US. Learn how to effectively navigate country-specific regulatory red flags.
The Recipe for Relief: Overcoming Industry Pain Points
Why investing in people and training can help drugmakers deal with six pressing challenges in particular in the year ahead.
Gilead Appoints Dietmar Berger as Chief Medical Officer
Berger joins Gilead with over 25 years of global drug development experience and will oversee the company’s virology, oncology, and inflammation portfolio.
Becoming More Human Through Technology, Instead of the Opposite
AI provides opportunities to bring people together—not replace them.
Why Healthcare Costs are Surging—And What to Do About it
Identifying the inflators and deflators, and the role all stakeholders play.
How Can We Ensure Ethical Use of AI in Pharma Marketing?
In this Pharmaceutical Executive video interview, Angela Tenuta, President, Full Service Agencies, at EVERSANA INTOUCH, identifies the most significant ethical concerns related to AI in pharma marketing.
Mastering Your AI Budget for 2025 Success
Because the AI space is changing rapidly, it’s essential that companies are budgeting correctly and using their investments strategically.
Klick Health Uses AI to Create Digital Hugs
The videos are designed to help bring people together during the holidays.
How to Build and Maintain Relationships with High-Profile Clients
For pharma manufacturers, the primary requirement for working with high-profile clients is matching their organizational level of urgency and organization.
Yescarta Demonstrates Promise in Treating Relapsed/Refractory Large B-Cell Lymphoma
Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high overall survival rate in patients with relapsed/refractory large b-cell lymphoma.
Quantifying the Benefits of AI-Powered Patient Adherence Programs
In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, identifies which metrics and KPIs can be used to measure the effectiveness of AI-powered patient engagement and adherence programs.
How Can Pharma Navigate the Regulatory Maze of AI-Powered Interventions?
In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, discusses how pharmaceutical companies navigate the evolving regulatory landscape to ensure that AI-powered interventions comply with relevant regulations and guidelines.
Peer Exchange: Embracing AI in Pharma
In this first part of this roundtable discussion, experts discuss the current perception of AI and how this is impacting adoption.
Trinity Life Sciences Releases Annual TGaS Digital Marketing Competency Report
The report gives high rankings to brands from Pfizer and AstraZeneca.
The Launch of SPIMA Therapeutics
Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the company’s launch and how multiple institutions have supported its pipeline.
National Comprehensive Cancer Network Adds Jazz’s Ziihera as a Category 2A Treatment Option for Biliary Tract Cancers
Ziihera’s addition as a category 2A treatment follows the FDA’s accelerated approval of the drug for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.
FDA Grants Priority Review to AstraZeneca’s Imfinzi for Muscle-Invasive Bladder Cancer
The FDA based the Priority Review designation on results from the Phase III NIAGARA trial, which found that Imfinzi reduced the risk of disease progression, recurrence, or death by 32% in patients with muscle-invasive bladder cancer.
FDA Accepts Roche’s Supplemental Biologics License Application of Columvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acceptance of the application was based on results from the Phase III STARGLO study, which found that Columvi demonstrated a statistically significant and clinically meaningful overall survival improvement in patients with relapsed or refractory diffuse large B-cell lymphoma.
The Ethical Implications of AI-Driven Patient Engagement
In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, explores the ethical implications of using AI to collect and analyze patient data, and improve outcomes.
Transforming “what if” to “what is” with the Veradigm Network
Our network connects providers, health plans, and life science companies to deliver seamless care that benefits everyone
Personalized AI-Powered Solutions for Better Patient Adherence
In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, identifies how AI can identify patients at risk of medication non-adherence and intervene early to prevent negative outcomes.
FDA Grants Breakthrough Therapy Designation to Merck’s Sacituzumab Tirumotecan for Metastatic Nonsquamous Non-Small Cell Lung Cancer
The breakthrough designation is based on data from the expansion cohort of a Phase I/II study evaluating sacituzumab tirumotecan in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.
Using AI to Predict and Influence Patient Behavior
In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, explains how AI can be leveraged to create highly personalized patient engagement strategies, tailored to individual needs and preferences.
FDA Accepts GSK’s Biologics License Application of Blenrep for Relapsed or Refractory Multiple Myeloma
Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7 and DREAMM-8 Phase III trials in patients with relapsed or refractory multiple myeloma.
Pharma Pulse 12/2/24: Retooling the ‘Gene’ Value Machine & more
The latest news for pharma industry insiders.
Pharma Pulse 11/25/24: Deepening Patient Relationships, Menopause May Increase Risk of Asthma & more
The latest news for pharma industry insiders.
FDA Expands Labeling for Roche’s Pathway Rabbit Monoclonal Primary Antibody in Patients with Biliary Tract Cancer
Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.
Pharma Pulse 11/26/24: RFID Technological Obstacles, Self-Care for the Flu & more
The latest news for pharma industry insiders.
Biohaven’s Taldefgrobep Alfa Fails to Achieve Statistical Significance in Treating Spinal Muscular Atrophy
Results of the RESILIENT SMA study found that while taldefgrobep demonstrated clinically meaningful motor function improvements in patients with spinal muscular atrophy, the treatment arm did not achieve statistical significance at 48 weeks.
ReviR Therapeutics Partners with Kennedy’s Disease Association for New Molecule Development
The two companies will work to develop treatments for SBMA.
Pharma Pulse 11/29/24: AI’s Role in Personalizing Life Sciences Digital Experiences & more
The latest news for pharma industry insiders.
FDA Approves AOP Health’s Rapiblyk for Atrial Fibrillation and Atrial Flutter
Approval was based on the combined results from five studies of adults with supraventricular tachycardia.
Pharma Pulse 11/28/24: Nov. 27 Passed—What Does That Mean for DSCSA? & more
The latest news for pharma industry insiders.
Sarepta, Arrowhead Strike Global Collaboration Deal to Develop Treatments for Rare Genetic Diseases Affecting Muscles
Agreement grants Sarepta exclusive rights to several clinical-stage programs for muscular dystrophy, myotonic dystrophy type 1, and more.
Pharma Pulse 11/27/24: Empowering Sites and Patients, Shingles Can Occur in Children & more
The latest news for pharma industry insiders.
Biden-Harris Administration Proposes Expansion to Medicare and Medicaid to Include Anti-Obesity Medications
The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.
Children’s Hospital of Philadelphia Announces New Imaging AI Technology
CelloType produces more accurate results when analyzing high content tissue images.
2024 Pharmaceutical Executive APEX Award Winners
2024 Pharmaceutical Executive APEX Award Winners
Exact Sciences Enlists Carlos Ponce to Promote Early Cancer Screening
The actor is part of a campaign for early colon cancer screening.
Pharma Pulse 11/21/24: A Global Standard for Data Sources, 75% of Adults are Obese & more
The latest news for pharma industry insiders.
Survey Suggests Pharma Industry Still Struggling with Digital Transformation
The results say that the industry still lacks talent and skills in this area.
Pharma Pulse 11/22/24: Challenges Facing the Pharma Industry in 2025 & more
The latest news for pharma industry insiders.
Dexcom Teams with Nick Jonas to Launch Diabetes Treatment Education Campaign
The campaign also includes partnerships with other celebrities, including Lance Bass and Retta.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
IDEAYA Names Stu Dorman as New Chief Commercial Officer
Dorman previously served as head of Gilead Sciences’ U.S. Oncology Unit.
FDA Grants Accelerated Approval to Jazz Pharmaceuticals’ Ziihera for HER2-Positive Biliary Tract Cancer
Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.
The Influence of PD-1 Inhibitor Label Restrictions on Future Studies
Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.
Pfizer Appoints New Chief Scientific Officer and President, Research and Development
Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role and lead all R&D functions including oncology.
FDA Approves Revuforj to Treat R/R Acute Leukemia with KMT2A Translocation
Syndax describes the drug as the first of its kind.
Blue Cross Blue Shield of Massachusetts Announces New Services Focused on Women’s Health
The news is part of the organization’s goal of demonstrating a commitment to women’s health.
Pharma Pulse 11/18/24: An Overview of RFID, Moving More Modifies Mood & more
The latest news for pharma industry insiders.
Rationale Behind the Recent FDA PD-1 Inhibitor Label Restrictions
Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions on PD-1 inhibitors for gastric cancers.
Drilling in on Disease Hallmarks: New Tricks to Solve Age-Old Problems
Ann Beliën, PhD, founder and CEO of Rejuvenate Biomed, discusses how AI is being used to find new ways to treat age-related conditions.
FDA Approves PTC Therapeutics’ Kebillidi for Aromatic L-Amino Acid Decarboxylase Deficiency
Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.
Noam Solomon: Bringing the Human Story to AI
A look at one biotech’s mission to map the immune system using artificial intelligence—and how its growth as a Big Pharma partner could help unlock the potential of next-generation cancer treatments.
AI’s Attention Span
Developments in the world of artificial intelligence continue to accelerate at a rapid pace. Our November issue of Pharmaceutical Executive explores a few of those that are starting to deliver measurable gains for the industry.
Pharmaceutical Executive: November 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive November 2024 issue in an interactive PDF format.
FDA Accepts Resubmission of Supplemental Biologics License Application for Dupixent for Chronic Spontaneous Urticaria in Patients Under 12
The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.
Tirzepatide Demonstrates Significant Benefits for Patients with Pre-Diabetes, Obesity Over 176 Weeks
Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.
ROI and Rare Disease: Retooling the ‘Gene’ Value Machine
Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for rare diseases—and increase the probability of economic success for a new wave of potential curative treatments for these conditions.
Navigating the Current Landscape for Pharma Leaders
Decisions and strategies related to remote work, AI, and DE&I are especially evolving.
Powering Pipelines Forward: Approach Science Differently
Why tapping the value generated for the next set of therapies is critical.
FDA Approves Autolus’ Aucatzyl for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
AstraZeneca, Daiichi Sankyo Submit Biologics License Application of Datopotamab Deruxtecan for Advanced Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer
Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.
FDA Lifts Clinical Hold on Novavax’s Trials for COVID-19-Influenza Combination, Standalone Influenza Vaccines
The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.
AbbVie’s Emraclidine Fails to Reduce Schizophrenia Symptoms Compared to Placebo
Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and Negative Syndrome Scale scores after six weeks of treatment for schizophrenia.
Pharma Pulse 11/8/24: Dusting Off One’s Cost Center Hat, Iron Supplements Benefit Children with HIV & more
The latest news for pharma industry insiders.
Advertising/Marketing Trends to Expect in Q1 of 2025
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab, identifies advertising/marketing trends he expects in Q1 of 2025.