James Foster, CEO and co-founder of Virax Biolabs, discusses how global launches are being impacted by changing geopolitical conditions.

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.

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 combat misinformation, close the trust gap, and so much more.

Meilog marks the first rapid-acting insulin biosimilar to gain FDA approval for the treatment of diabetes.

How one Big Pharma ad campaign is incorporating diversity as a driving force in improving the ways drugs are marketed directly to the patients that need them.

The TileDB CEO discusses how the life sciences can overcome these limitations.

The benefits for brand teams in bolstering their rapid-response capability.

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.

James Foster, CEO and co-founder of Virax Biolabs, discusses how companies can strategize despite hard-to-predict regulatory headwinds.

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.

James Foster, CEO and co-founder of Virax Biolabs, discusses how the industry is preparing for potential regulatory changes to vaccine policy.

Polypharmacy, biosimilars, and GLP-1s among the evolving trends likely to play out in the pharmacy benefits space.

HEOR requires executive leaders who have both scientific and managerial acumen.

Demonstrating clinical benefit is the ultimate gateway to smoother patient access.

A change in political power is altering how companies are strategizing around the IRA.

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 Phesi CEO discusses his company’s recent analysis of the most studied diseases in the world.

Bill Grambley, CEO of AllazoHealth, delves into the potential of AI to revolutionize patient engagement and adherence.

Data from the Phase III FRONTIER3 trial found that 98% of caregivers prefer Mim8 for hemophilia A over other treatments.

The latest news for pharma industry insiders.

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.

Biljana Naumovic discusses the importance of finding ways to reach out to underserved communites.

Legos will take over from Roger Dansey, who will begin transitioning to retirement.

Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.

New technology is creating new opportunities but is also causing new complications.

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.

Susan Cantrell responds to the tariffs on China, Canada, and Mexico.

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.

Biljana Naumovic of Johnson & Johnson discusses the unique fashion show and how it’s raising awareness for prostate cancer.

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.

The latest news for pharma industry insiders.

President Trump’s tariffs will include imported pharmaceuticals, among other items that will impact the industry.

The latest news for pharma industry insiders.

2025 Pharma Forecast: Four Pivotal Trends Revolutionizing Market Access Strategies

A Harvard Business School Healthcare Alumni Association Q&A with Paul Ollinger, one of Facebook’s first 250 employees.

Approval of Journavx for acute pain marks the first new class of acute pain medication approved by the FDA in over 20 years.

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.

Daniel Vitt, CEO, Immunic Therapeutics, discusses promising results from the Phase Ib trial of IMU-856 in celiac disease.

Senators Durbin and Grassley proposed the new regulations for direct-to-consumer pharma advertising.

Q4 earnings for companies such as Johnson & Johnson, Teva, and Roche highlight the impact of significant innovations brought to market last year.

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.

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.

The latest news for pharma industry insiders.

Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the approval of Spravato for treatment-resistant depression.

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.

The government agency says X no longer suits its communication needs.

Veeva’s vice president of commercial strategy discusses how streamlining their processes with a single goal in mind can improve their relationships with customers.

New partnership hopes to give BSS patients more options for treatment.

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.

The latest news for pharma industry insiders.

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.

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.

Paul Howe, chief commercial officer at Protega, discusses efforts to combine high tech solutions with pain-management medications.

Trial findings show long-term recurrence-free survival in patients with low-grade upper tract urothelial cancer treated with Jelmyto.

Ash Shehata from KPMG discusses how artificial technology has a lot to prove, although investors still see a lot of potential in it.

The trial, developed in collaboration with Novotech, will specifically target dietary and alcohol-induced overindulgence.

This is the latest AI tool from the company to provide insights from public sources.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses AD04’s development timeline and next steps towards approval for alcohol use disorder.

The latest news for pharma industry insiders.

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.

Ash Shehata from KPMG discusses how investors are feeling about the pharma and life sciences industry heading into 2025.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses promising results of the AD04-13 study in patients with Alcohol Use Disorder

The latest news for pharma industry insiders.

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.

As part of the Inflation Reduction Act, price negotiations with manufacturers will begin this year, with reduced prices expected to take effect in 2027.

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.

Jason Foster, CEO of Ori Biotech, discusses the difficulties preventing more widespread adoption of these advanced therapies.

Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host disease.

The latest news for pharma industry insiders.

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.

The company revealed plans to increase the usage of AI in pharma at JP Morgan’s healthcare conference in San Francisco.

John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials for idiopathic pulmonary fibrosis.

The latest news for pharma industry insiders.

Organizations including Gilead, Eli Lilly, and AbbVie announced a number of deals addressing inflammatory diseases, multiple myeloma, and other disease areas.

Mary Kosinski joined the firm as global managing director for the sector, along with other leadership additions.

Dan Monahan will serve in the role as the drug goes through Phase III trials.

‘Shape Shifting’ is a creator-led series that focuses on the scientific and cultural impact of GLP-1s.

Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.

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.

Company leadership urged members and employees to stay safe and follow evacuation orders.

The campaign will include patient stories, education resources, and is being held in partnership with the Glaucoma Research Foundation.

Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.

Both companies have produced AI-powered technology that improves data collection and analysis.

This acquisition will help generate data from over four million members of MyHealthTeams’ opted-in patient universe.

Breakthrough Therapy Designation for GSK5764227 was based on data from the ARTEMIS-002 Phase II trial, which demonstrated promising efficacy and safety in 42 osteosarcoma patients.

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.

The designation marks VGA039 as the first drug candidate to receive FDA Fast Track designation for von Willebrand disease.

Guidance marks the regulatory body’s first on artificial intelligence applications in drug and biological product development.

GlobalData’s new findings show that the Zepbound may become the top WLM in the coming year.

The latest news for pharma industry insiders.

A Q&A with Harvard’s Laura Wegner, serial entrepreneur and Rhodes Scholar-elect.

PCV21 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a Phase III clinical trial in infants and toddlers.

Under terms of the deal, Johnson & Johnson will gain an exclusive license to the STAT6 program, with Kaken maintaining commercialization rights in Japan.

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.

Approval was based on results from the Phase III CheckMate-67T trial, which demonstrated non-inferior pharmacokinetics compared to intravenous Opvido.

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.

GLP-1s continue to dominate the market, but can pharma keep up with the demand?

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.

Point of care messaging and AI resulted in more targeted campaigns over the past year.

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.

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 patients.

Check out our top five most engaged social media posts from the year 2024.

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, explores the key factors driving the increasing number of partnerships between telehealth and pharmaceutical/medical device companies.

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.

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 and prevent them.

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 sensitive as fertility.

New technologies are creating more efficient ways for pharma companies to work directly with consumers.

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?

The top five episodes of our podcast in the year 2024, highlighted.

John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

Pharm Exec covered key players in the industry over the past year.

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.

The latest news for pharma industry insiders.

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.

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.

Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.

The molecule is an investigational pre-clinical oral GLP-1 receptor agonist.

The latest news for pharma industry insiders.

In the third part of this roundtable discussion, experts discuss the issues with data that AI must overcome.

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 2025.

These professionals in the healthcare marketing sector have been chosen by their peers for making big moves and taking on larger roles.

The technology provides the industry with many opportunities, but it must also navigate a complex regulatory landscape.

Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of prostate cancer.

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.

Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.

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.

The biosimilars market in the US is on the rise, but barriers to greater adoption remain.

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.

With the Inflation Reduction Act now in flux, how will the government and industry respond?

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 look at the promise and opportunities from this new and advanced type of AI in transforming commercial planning and execution for life sciences companies.

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.

Industry voices stress importance of a strategic approach to social media marketing, choosing platforms wisely, prioritize privacy, leveraging targeted advertising techniques and more.

Berger joins Gilead with over 25 years of global drug development experience and will oversee the company’s virology, oncology, and inflammation portfolio.

Why investing in people and training can help drugmakers deal with six pressing challenges in particular in the year ahead.

The importance of expanding your pharma sales forecasting horizon beyond the US. Learn how to effectively navigate country-specific regulatory red flags.

AI provides opportunities to bring people together—not replace them.

Identifying the inflators and deflators, and the role all stakeholders play.

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.

Because the AI space is changing rapidly, it’s essential that companies are budgeting correctly and using their investments strategically.

The videos are designed to help bring people together during the holidays.

For pharma manufacturers, the primary requirement for working with high-profile clients is matching their organizational level of urgency and organization.

Breakthrough designation was based on results from the TROPION-Lung05 Phase II trial with support from the TROPION-Lung01 Phase III trial of datopotamab deruxtecan in patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

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.

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.

In this first part of this roundtable discussion, experts discuss the current perception of AI and how this is impacting adoption.

The report gives high rankings to brands from Pfizer and AstraZeneca.

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.

Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the company’s launch and how multiple institutions have supported its pipeline.

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.

Approval of Imfinzi was based on results from the ADRIATIC Phase III trial, marking the first systemic immunotherapy available for limited-stage small cell lung cancer.

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 breakthrough designation is based on Phase II clinical trial data, which demonstrated that ATX101 provides sustained pain relief for up to four weeks following total knee arthroplasty.

Our network connects providers, health plans, and life science companies to deliver seamless care that benefits everyone

Licensing deals are expected to enhance the oncology, neuroscience, and antibody drug conjugate pipelines of the three manufacturers.

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.

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.

Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic CAR T-cell therapy for multiple myeloma, and P-CD19CD20-ALLO1, a dual CAR T-cell therapy in early trials for B-cell malignancies and autoimmune diseases.

The actor is part of a campaign for early colon cancer screening.

The latest news for pharma industry insiders.

The latest news for pharma industry insiders.

CelloType produces more accurate results when analyzing high content tissue images.

The two companies will work to develop treatments for SBMA.

The latest news for pharma industry insiders.

The latest news for pharma industry insiders.

The latest news for pharma industry insiders.

Approval was based on the combined results from five studies of adults with supraventricular tachycardia.

Agreement grants Sarepta exclusive rights to several clinical-stage programs for muscular dystrophy, myotonic dystrophy type 1, and more.

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.

The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.

2024 Pharmaceutical Executive APEX Award Winners

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

The drug, developed by UCB, is approved to treat adults with the inflammatory skin disease.

The latest news for pharma industry insiders.

The results say that the industry still lacks talent and skills in this area.

The latest news for pharma industry insiders.

The campaign also includes partnerships with other celebrities, including Lance Bass and Retta.

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.

Dorman previously served as head of Gilead Sciences’ U.S. Oncology Unit.

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.

Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role and lead all R&D functions including oncology.

Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.

Syndax describes the drug as the first of its kind.

The news is part of the organization’s goal of demonstrating a commitment to women’s health.

The latest news for pharma industry insiders.

Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions on PD-1 inhibitors for gastric cancers.

Ann Beliën, PhD, founder and CEO of Rejuvenate Biomed, discusses how AI is being used to find new ways to treat age-related conditions.

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.

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.

Click the title above for a link to open the Pharmaceutical Executive November 2024 issue in an interactive PDF format.

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.

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.

Exploring those areas and functions where the application of generative artificial intelligence—through use cases borne out in practice—are demonstrating tangible value and driving life sciences innovation to new heights.

Why tapping the value generated for the next set of therapies is critical.

Pharma looks to take advantage of expanded access programs across Asia-Pacific region.

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.

The latest news for pharma industry insiders.

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.

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