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Healthcare discussions are booming on the Internet. How will FDA allow pharma to participate?

Pharma, FDA Wrestle with Social Media Tools

With sales of human pharmaceuticals languishing, several factors are focusing increased attention on animal health products, once a little-noticed industry niche market

Industry Mergers Reshuffle Animal-Health Leadership

While storm clouds gather over pharma sales activities, marketers look to e-sampling as a potential alternative

Interest Grows in Handling Physicians' Samples Electronically

Among sales-force automation tools, closed-loop marketing is getting attention as a better way to sell

Will Closed-Loop Marketing Energize the Pharma Sales Process?

Johnson & Johnson will be purchasing all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders, for $132.00 per share in cash, in a deal valued at approximately $14.6 billion.

“Building on our nearly 70-year legacy in neuroscience, this unique opportunity to add Intra-Cellular Therapies to our innovative medicine business demonstrates our commitment to transforming care and advancing research in some of today’s most devastating neuropsychiatric and neurodegenerative disorders,” said Joaquin Duato, chairman and CEO, Johnson & Johnson. “This acquisition further differentiates our portfolio, serves as a strategic near- and long-term growth catalyst for Johnson & Johnson, and offers compelling value to patients, health systems and shareholders.”

per  this agreement, Johnson & Johnson adds Intra-Cellular Therapies’ Caplyta (lumateperone), which is a once-daily oral therapy that’s FDA-approved to treat adults with schizophrenia, along with depressive episodes that are connected to bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive treatment with lithium or valproate.

The acquisition also includes ITI-1284, a Phase II compound that is currently being analyzed in Alzheimer’s disease-related psychosis and agitation along with generalized anxiety disorder (GAD),

 as well as a clinical-stage pipeline that further supplements and J&J’s focus area.

“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson,” commented Jennifer Taubert, executive vice president and worldwide chairman of innovative medicine, Johnson & Johnson. “Together, we have an opportunity to impact even more patients living with neuropsychiatric and neurodegenerative disorders, significantly advancing care and helping improve the lives of millions worldwide.”

In December of last year, Intra-Cellular Therapies submitted a supplemental new drug application (sNDA) to the FDA for Caplyta as an additional treatment for adults with major depressive disorder (MDD).

 In fact, two global, double-blind, placebo-controlled Phase III studies demonstrated Caplyta to provide a statistically significant improvement in depressive symptoms, per the standards of clinician-rated and patient-reported outcomes.

There are also ongoing Caplyta Phase III trials surrounding bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania). Positive results measuring the efficacy and safety of the drug for the prevention of relapse in adult patients with schizophrenia were shared in November 2024.

“CAPLYTA’s success and the robust pipeline we have built demonstrates the passion and dedication of our talented team, and we are proud of the hundreds of thousands of patients we have helped,” commented Dr. Sharon Mates, chairman and CEO of Intra-Cellular Therapies. “Johnson & Johnson has a longstanding commitment to neuroscience, and we believe together, we can reach even more patients around the world.”

1. Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. 

. January 13, 2025. Accessed January 13, 2025. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-strengthens-neuroscience-leadership-with-acquisition-of-intra-cellular-therapies-inc

2. Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales Guidance. 

. August 7, 2024. Accessed January 13, 2025. 

https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-reports-second-quarter-2024-financial

3. Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy. 

. December 3, 2024. Accessed January 13, 2025. 

https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-submits-supplemental-new-drug

4. Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. 

. November 5, 2024. Accessed January 13, 2025. 

https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-positive-topline-results-2

The acquisition features Caplyta as part of its neuroscience portfolio, which is considered the only FDA-approved treatment for bipolar I and II depression as a monotherapy and adjunctive treatment.

J&J Inks $14.6 Billion Intra-Cellular Therapies Deal

The Impact of Digital Transformation in 2025

According to a new report from Deloitte, the life sciences industry will have a transformative year. The industry faces renewed scrutiny over pricing and access, but new technologies are providing new solutions. Pete Lyons, vice and US life sciences sector leader at Deloitte Pete Lyons discusses the report’s findings and other key trends for the coming year.

Rural Women Experience Worse Menopausal Symptoms and Limited Resources, Study Finds

A new, first-of-its-kind study found that these symptoms occur particularly during the late menopause transition and post-menopause.

Amazon Plans to Invest at Least $11 Billion in Cloud and AI Infrastructure in Georgia

The investment aims to meet the increased demand for advanced cloud infrastructure and compute power, driven by generative AI, it said. Amazon has invested $18.5 billion in the state since 2010. 

Celmatix Launches Novel Endometriosis Drug Program

Celmatix Therapeutics announced its latest drug program, a novel Jun-N-terminal kinase (JNK) inhibitor that targets pain and inflammation. The therapeutic drug candidate, developed using the DNA-Encoded Chemistry Technology (DEC-Tec) platform at the Center for Drug Discovery, Baylor College of Medicine (BCM), aims to address a critical unmet need in first-line treatments for a range of women’s health indications, starting with endometriosis and potentially extending to Polycystic Ovary Syndrome (PCOS) and ovarian aging.

The Axia Institute - Michigan State University on LinkedIn

As innovators, we're already looking beyond 2025. We're not stopping with meeting regulatory requirements that provide end-to-end visibility of pharmaceutical drugs. In the future, using RFID and NFC technologies can provide patients with valuable information about their medication, hospitals with a more secure supply chain, and manufacturers with a stronger competitive advantage. Hear more about the future of RFID in the pharmaceutical supply chain in the last segment of "Peer Exchange: The Future of RFID and Supply Chain Management" with 

, featuring Axia's Bahar Aliakbarian, PhD.

Have news you want us to share in Pharma Pulse? Reach out to Editor 


The latest news for pharma industry insiders.

Pharma Pulse 1/9/25: Digital Transformation's Impact on 2025, Rural Women Experience Worse Menopausal Symptoms/Limited Resources & more

In exchange for his support of Donald Trump’s candidacy for president, Robert F. Kennedy threw his own name into the mix, and has officially been nominated by the president-elect as the as next Secretary of Health and Human Services. His stated objective is to focus on food safety, referencing the proliferation of processed foods and additives, and tackle the increase in chronic diseases.

However, given RFK’s reputation as a vaccine denier, putting him in this position could scare some. Setting RFK’s candidacy aside, is there a need to develop a better integrated policy that addresses population health issues and disease prevention with a critical look at our food supply and breaking out of food and pharmaceutical silos?

There is significant evidence that many of the ingredients in food products that we find on the shelves in supermarkets are simply unhealthy. Widespread consumption of high-fructose corn syrup has contributed to multiple health consequences, such as insulin resistance, obesity, liver disorders, and diabetes.

 Poor metabolic health has further been linked to diabetes, cancer and Alzheimer’s disease.

 Many other ingredients in our food products have been found to have a negative impact on our health. Propylene glycol, an emulsifier, is widely used in, for example, low-fat salad dressings and the main ingredient in some deodorants. It can cause very severe allergies, which do not clearly show up in allergy skin tests.

 Ironically, most of the dermatological prescription ointments used to treat the resulting eczema also contain propylene glycol. There is a long list of food ingredients that the FDA deems non-toxic, but that are, nevertheless, causing damage. California has started to ban

 a number of ingredients from public school foods and beverages. In my opinion, the FDA seems to act as a follower rather than a leader in this area.

As mentioned, metabolic disease is thought to be a major contributor in cardiovascular disease, cancer, and Alzheimer’s disease. With a third of the US population being obese, and an additional third overweight, the need for good treatments is humanistically and economically crucial. Alzheimer’s disease alone is projected to bankrupt Medicare,

 state Medicaid programs, and individual patients if effective treatments are not found.

The pharmaceutical industry has been able to provide many new treatment options for debilitating diseases. Some anti-cancer drugs have been able to significantly alter the course of the disease. Progress has been made with Alzheimer’s disease drugs as well, but we are still far off from widespread meaningful treatment solutions for these and many other diseases, some of which are believed to be primarily caused by our unhealthy lifestyles and the foods that we consume.

The glucagon-like peptide-1 (GLP-1) agonists semaglutide and high-dose liraglutide are FDA-approved drugs to help the treatment of obesity. Beyond obese patients, these drugs have helped many overweight and individuals reverse the impact of poor nutrition and lifestyle habits, but we need to ask ourselves whether weight losses are sustainable in the long term and whether they further accommodate poor diets.

Provider organizations are increasingly considering the need for social care for patients in addition to their medical treatments, emphasizing relationships between housing, social setting, and therapy outcomes. Social care programs, such as the National Diabetes Prevention Program, assist patients with getting access to food, housing, healthcare, and other social services.

On a government level, we may also need a better integration between all health-related policies, including food (FDA-approved ingredients and related communications), prevention- and treatment-focused medical care, and sports/recreational investments. Individuals have a personal responsibility to make the right choices, but today, choices may simply not be available or insufficiently communicated and incentivized. Is clear labeling enough, or should certain ingredients (such as the aforementioned high-fructose corn syrup) be banned from foods?

The pharmaceutical industry is currently benefiting from the GLP-1 hype and it may save lives of individual patients. However, what will be the longer-term impact on population health? The next generation of obesity drugs may be very safe and effective, but wouldn’t it be better if less than two-thirds of the population need them?

Ed Schoonveld is a value & access advisor for Schoonveld Advisory and author of The Price of Global Health.

1. Samuels B. Trump Says He’ll Let RFK Jr. ‘Go Wild’ on Health and Food in Potential Second Term. 

https://thehill.com/homenews/campaign/4956319-trump-says-hell-let-rfk-jr-go-wild-on-health-and-food-in-potential-second-term/

2. Mai, B.H.; Yan, L.J. The Negative and Detrimental Effects of High Fructose on the Liver, With Special Reference to Metabolic Disorders. 

 https://pubmed.ncbi.nlm.nih.gov/31213868/

Outlive: The Science of Art and Longevity.

https://www.euronews.com/green/2019/01/07/the-truth-behind-propylene-glycol#:~:text=Allergy%20risk%20of%20propylene%20glycol&text=The%20US%20Food%20and%20Drug,reported%20in%20the%20scientific%20literature

5. Wick, J.Y. And the Allergen Winner is: Propylene Glycol! 

https://www.contemporaryclinic.com/view/and-the-allergen-winner-is-propylene-glycol

6. Siegner, C. California Bans More Ingredients. 

https://www.foodbusinessnews.net/articles/26905-california-bans-more-ingredients#:~:text=Beginning%20on%20Jan.,Missouri%2C%20New%20York%20and%20Washington

7. Alzheimer’s Association’s Most Expensive Disease Handout. Alzheimer’s Association

https://act.alz.org/site/DocServer/112114_Most_Expensive_Disease_Handout.pdf?docID=40161

Is the potential of a more formal policy integration for health issues and disease prevention a scary suggestion or a good idea?

Policy and Population Health

Copay, Reimbursement, and Access Congress—an Informa Connect conference held in Philadelphia this past November—provided an essential forum for healthcare professionals, policy experts, and industry leaders to tackle some of the most pressing challenges in the evolving access and reimbursement landscape. With a diverse array of panel discussions and presentations, the three-day conference shed light on national policy trends, strategic solutions, and best practices for advancing patient access to care and optimizing stakeholder reimbursement strategies.

Among the standout sessions were two presentations focusing on key legislative and regulatory updates and actionable strategies to enhance access and affordability for medical benefit products.

The session titled "Legislative and Regulatory Update: Executive Policy Address" was delivered by Mark Gooding, managing director at Avalere Health, and Kate Sikora, deputy vice president of policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA). This presentation centered on the impact of shifting healthcare policies and legislative changes, particularly in anticipation of the new Congress and Presidential administration set to take shape this month.

The panel discussion focused on two key topics:

State of play across key healthcare policies

: Gooding and Sikora detailed several critical issues influencing patient access, including copay adjustment programs (accumulators and maximizers), alternative funding programs (AFPs), and ongoing pharmacy benefit manager (PBM) reforms. Additionally, the speakers highlighted the Inflation Reduction Act policies set to launch in 2025, such as the Medicare Prescription Payment Plan (also known as Part D out-of-pocket smoothing), and the potential impacts on drug pricing.

Post-election landscape and legislative priorities

: The session also explored how the 2024 elections outcomes will lead to an expected shift in priorities. Both speakers addressed the likelihood of increased legislative activity around transparency in copay support, PBM payment structures, and additional state-level restrictions on accumulator programs (see Figure 1).

Gooding emphasized that stakeholders, including manufacturers and payers, need to prepare for regulatory uncertainties and the evolving policy environment. Sikora reiterated the importance of tracking legislative developments, particularly state-level reforms that often serve as precursors to federal action.

Another session at the Congress, “Optimizing Coding and Billing Strategies to Enhance Access in Programs for Medical Benefit Products,” featured Jessica Cortez, principal at Avalere Health; Ticia Cawley, vice president of client solutions at ConnectiveRx; and Lilian Buch, director of reimbursement strategy at Amgen. This session focused on the role of coding and billing in ensuring seamless access to medical benefit products and reducing barriers for patients.

Three key areas that were highlighted in the session include the following.

Understanding coding systems and their relevance

: The panel outlined common coding frameworks, including the Healthcare Common Procedure Coding System (HCPCS), Current Procedural Terminology (CPT), and the National Drug Codes (NDCs). They emphasized the importance of precise coding for coverage and reimbursement. Cortez noted that codes start translating the patient journey into payer language, while inaccurate coding can impact coverage decisions, reimbursement rates, and the financial health of providers and patients.

Affordability programs and product launch considerations

: Buch shared best practices for aligning affordability programs with product-specific coding and billing strategies. She stressed tailoring support to address payer requirements and ensuring that benefit verification processes are streamlined. Cawley discussed emerging trends in buy-and-bill claims, assignment of benefits (AOB) processes, and hybrid coverage models that combine pharmacy and medical benefits programs.

: A key takeaway here was the need to remain updated with evolving coding and billing standards. The panel highlighted risks, such as coding errors, misaligned documentation, and the impact of off-label use. Attendees were urged to implement robust environmental analysis of coding changes by following CMS for ICD-10 dockets, Physician Payment rulemaking, and the American Medical Association (AMA)’s CPT dockets and provider notices to understand how the evolution of the coding system will change their access and affordability program post-launch.

The panelists emphasized the importance of having clear communication between stakeholders—manufacturers, reimbursement teams, and field staff—to ensure successful program execution. Cawley recommended leveraging technology to track key performance indicators, such as claim patterns, average copay amounts, and persistency data to optimize access programs.

The importance of building resilience through strategic partnerships

The insights shared in both sessions underscored the interconnected nature of policy changes, coding strategies, and access optimization. Key takeaways include:

: Stakeholders must proactively monitor legislative and regulatory changes, particularly given the shifting political environment post-2025 elections.

: Accurate and efficient coding processes are critical to minimizing access barriers and improving affordability.

: Collaboration with expert organizations can help manufacturers and payers navigate complex policy shifts and operational challenges.

As the access and reimbursement landscape evolves, forums like the Copay, Reimbursement, and Access Congress are facilitating dialogue among stakeholders and sharing solutions. By embracing innovation, compliance, and strategic partnerships, industry stakeholders can ensure that patients maintain access to needed therapies while navigating an increasingly complex regulatory environment.

Jessica Cortez is a principal at Avalere Health with experience establishing partnerships with life sciences companies to drive strategic initiatives focused on transformation. Cortez leads the annual review of the Medicare Physician Fee Schedule (MPFS), specializing in coverage, coding, regulatory, and economics.

Mark Gooding, also of Avalere Health, is a managing director who provides life sciences companies strategic guidance on policy developments and reimbursement considerations. He analyzes federal- and state-level policies, and develops strategies to drive coverage and improve market access.

A forum intended for HCPs, policy experts, and industry leaders addresses pressing obstacles facing this sector of the industry today. 

Latest Conference Coverage

Navigating Access and Reimbursement Through Uncertainty 

Industry Challenges

PC: What have been some of your goals in terms of what you wanted to accomplish here at Trade & Channel Strategies?

I always look at Trade & Channel as a nice capstone to the year. It's a great time to assess what's been accomplished in the year and get ready for the coming year, and also connect with a lot of great industry colleagues to find out what the hot issues are. Obviously, our goals were to do all those things, and I think the biggest thing that happens is we use this meeting as a springboard into next year by setting the stage for addressing a lot of those key issues that are discussed here at the meeting.

PC: Have there been any sessions in particular that have caught your eye?

There are two that stand out right now. First is the keynote session, which is speaking to the issues that the industry is facing across stakeholders in terms of the pressure from regulatory and the impact from the Inflation Reduction Act. It’s getting challenging now in terms of margin compression and regulatory issues that have to be dealt with in compliance. There’s also a number of headwinds ahead, primarily from a standpoint of more GenMed and what I would call tweener therapies. There’s still room to maneuver from the standpoint of specialty therapies and infuse therapies in the pipeline.

I would say that in general, the main context is how are we dealing with some of these and what structural changes do we need to make to be able to still be profitable, competitive, and grow in this more challenging environment. The other is just around data, obviously AI, and the impact of AI on everything we do is upon us. There was a great session on data and analytics that I just attended. Where do we apply AI, where do we start first when we're trying to enhance and create new structures for data governance and data management?

Jon Hamrick, partner, Curatio Scientia Advisors, discusses upcoming industry challenges at this year's Trade & Channel Strategies Conference in Philadelphia. 

Trade & Channel Strategies 2024: Navigating Industry Challenges

Today, there are various health-related social needs (HRSNs) that oftentimes go unmet—such as food insecurity, transportation challenges, housing instability, and utility obstacles—which can impact a person’s health. With healthcare being considered a shared responsibility that spans multiples sectors and contributes to enhancing both the health of the population and health equity, efforts—specifically in the United States—have been underway to design a system that utilizes social care to tackle HRSNs, while reducing health inequities.

When it comes to physicians, addressing HRSNs in a clinical practice setting could include screening and connecting patients to social services,

 and interestingly enough, their engagement when it comes to addressing HRSNs has not been fully measured thus far. Keeping that in mind, a cross-sectional study published in 

 sought to not only determine physicians’ engagement in addressing HRSNs, but do so while also examining its association with burnout.

 The study authors also noted that currently, there is limited understanding regarding how different subgroups of physicians spend time addressing these HRSNs.

The aforementioned study used the 2022 Association of American Medical Colleges National Sample Survey of Physicians (NSSP), which is a nationally representative survey of active, practicing physicians in the US that was conducted from May to November 2022. It measures various physician workforce characteristics.

The method for sampling was broken down into the following steps:

The process of including all eligible respondents from the NSSP 2019 survey

Filling the cohort through with the use of stratified random sampling, with strata consisting of physician gender, specialty group, age group, and rural status.

Overall, in the study totaling 5,447 physicians, the mean (SD) age was 50.9 (11.7) years, with 3,735 (68.6%) identifying either as men or transgender men. Also, 34.3% of physicians reported high HRSN engagement, with variability being based on physician characteristics. When being compared to no HRSN engagement, low to moderate HRSN engagement (adjusted odds ratio [AOR], 1.33; 95% confidence interview or CI, 1.03-1.72; 

 = .03) and high HRSN engagement (AOR, 1.72; 95% CI, 1.39-2.27; 

 < .001) were significantly associated with high burnout.

However, the study did present its share of limitations, specifically pertaining to its design. As a result of it being cross-sectional, the investigators were unsuccessful in finding a causal relationship between physicians’ engagement in addressing social needs and burnout. Another limitation included the fact that because physician-reported frequency of addressing HRSNs based on the 2022 NPPS item was used as a way to represent their engagement, the results may not necessarily reflect physicians’ involvement in addressing HRSNs in an accurate manner.

“ … We identified variability in physicians’ engagement in addressing HRSNs and found that a higher degree of engagement was associated with burnout, concluded the study investigators. “As growing numbers of health equity strategies are developed and implemented, our study findings offer insight into strategies for mitigating physician burnout and suggest the need for a thorough assessment of the potential unintended consequences of physicians’ engagement in addressing HRSNs on their well-being.”

1. Tabata-Kelly M, Hu X, Dill MJ, et al. Physician Engagement in Addressing Health-Related Social Needs and Burnout. 

2. Kreuter MW﻿, Thompson T﻿, McQueen A﻿, Garg R﻿. Addressing Social Needs in Health Care Settings: Evidence, Challenges, and Opportunities for Public Health.

Is this level of involvement with HRSNs associated with higher burnout? 

Mike Faden

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