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, closing the trust gap, and more.

Click the title above for a link to open the Pharmaceutical Executive February 2025 issue in an interactive PDF format.

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

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

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

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

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

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.

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.

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

As part of the funding, Latent Labs aims to leverage generative artificial intelligence to computationally create novel therapeutic molecules, such as antibodies and enzymes, to improve molecular features.

The energy component—and cost—associated with artificial intelligence should not be overlooked in all the excitement.

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

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.

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.

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.

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

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

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

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.

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.

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 FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with Enhertu.

The latest news for pharma industry insiders.

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

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

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.

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.

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

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

The Phase III trial builds on findings from prior findings that indicated Anktiva can restore T-cell function and improve overall survival in patients with advanced of metastatic non-small cell lung cancer who are PD-1 checkpoint inhibitor resistant.

Effective February 10, 2025, Mamilli will assume global responsibility for the Informatics function for the Roche Group.

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.

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

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.

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

Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with Alzheimer disease administered Leqembi.

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

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

The latest news for pharma industry insiders.

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

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.

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.

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

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

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.

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

Spravato is the first and only monotherapy to gain FDA approval for treatment-resistant depression.

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.

Panel participants share an optimistic outlook for integrating new innovations, tacking community-level challenges, and more.

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.

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

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.

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.

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

Approval was based on results of the VIVID-1 study, which found that Omvoh demonstrated significant clinical remission and endoscopic response rates in patients with Crohn disease.

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.

New partnerships aim to expand Teva’s biosimilar portfolio and enhance access to high-cost biologics across key markets.

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

The latest news for pharma industry insiders.

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

‘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.

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

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

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

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

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

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.

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.

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

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.

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

The latest news for pharma industry insiders.

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.

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

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.

The future of CAR T-cell therapies will continue to improve as they expand to other patients in need.

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.

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

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?

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

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

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.

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

What can we do to prevent such blatant black eyes to the industry so many of us love?

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

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.

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.

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

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 latest news for pharma industry insiders.

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.

This will bring Nimble’s psoriasis and inflammatory bowel disease treatment under AbbVie’s pipeline.

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.

The latest news for pharma industry insiders.

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.

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

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

In the second part of this roundtable discussion, experts discuss how the industry is handling AI in the marketing space.

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

This acquisition will bring Aliada’s Alzheimer’s treatment under AbbVie’s pipeline.

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

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.

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.

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, identifies which metrics and KPIs can be used to measure the effectiveness of AI-powered patient engagement and adherence programs.

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 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.

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

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.

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.

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

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.

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.

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.

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.

The latest news for pharma industry insiders.

The latest news for pharma industry insiders.

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 latest news for pharma industry insiders.

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 two companies will work to develop treatments for SBMA.

The latest news for pharma industry insiders.

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

The latest news for pharma industry insiders.

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

The latest news for pharma industry insiders.

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

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

2024 Pharmaceutical Executive APEX Award Winners

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

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.

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

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

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.

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

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.

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.

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.

Decisions and strategies related to remote work, AI, and DE&I are especially evolving.

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

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.

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 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.

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.

The latest news for pharma industry insiders.