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Data from prior Phase II study showed signs of pridopidine slowing disease progression in patients with amyotrophic lateral sclerosis.

Prilenia Announces Plans to Initiate Global Phase III Study of Novel ALS Treatment

Pivmecillinam (Pivya) has a clinical cure rate of 95% in uncomplicated urinary tract infections and is recommended as a first-line option for treatment in many countries.

Antibiotic for Uncomplicated Urinary Tract Infections Granted FDA Priority Review

Critical factors need to be addressed for pharma stakeholders to realize the full potential of generative artificial intelligence.

Generative Artificial Intelligence Could Transform Healthcare if Challenges Are Addressed

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel for Severe Sickle Cell Disease

The latest staff report from the FTC revealed that CVS Caremark, Express Scripts, and OptumRx also known as the “Big 3” pharmacy benefit managers (PBMs)—hiked up the prices of various specialty generic drugs that were dispensed at their affiliated pharmacies by as much as thousands of percent, resulting in them (and their affiliated pharmacies) making more than $7.3 billion in excess revenue when measured alongside the national average drug acquisition cost, or NADAC.

The report examined 51 specialty generic drugs—including 882 total National Drug Codes (NDCS) that were dispensed from 2017 to 2022, for members of commercial health plans and Medicare Part D prescription drug plans that were managed by the Big 3. NDCs are universal identifiers for all human drugs. The report also noted that these revenues were accumulating while patient, employer, and other healthcare plan sponsor payments for drugs were rising yearly.

“The FTC staff’s second interim report finds that the three major pharmacy benefit managers hiked costs for a wide range of lifesaving drugs, including medications to treat heart disease and cancer,” said FTC Chair Lina M. Khan. “The FTC should keep using its tools to investigate practices that may inflate drug costs, squeeze independent pharmacies, and deprive Americans of affordable, accessible healthcare—and should act swiftly to stop any illegal conduct.”

FTC’s latest deep dive builds off an original July 2024 report,

 which had uncovered that pharmacies that were affiliated with the Big 3 had received 68% of the dispensing revenue amassed by specialty drugs in 2023, a boost from the 54% figure in 2016. The latest report analyzed a broader set of specialty generic drugs—as opposed to two specialty generic drugs analyzed in the July 2024 report—and determined that the Big 3 PBMs impose significant markups on a wide array of specialty generic drugs.

Other key findings of the report included:

From 2017-2021, PBM-affiliated pharmacy dispensing revenue in excess of NADAC rose at a compound annual growth rate of 42%. In that timeframe, the top 10 specialty generic drugs generated $6.2 billion of dispensing revenue in excess of NADAC, representing 85% of the total.

Several drug categories, including oncology, had drugs that were marked up over 1000%. For example, Capecitabine—a branded form of Xeloda for the treatment of breast and colorectal cancer—experienced a 3,289% markup in 2021.

These PBMs accumulated an estimated $1.4 billion worth of income from spread pricing on these specialty generic drugs, which is when they bill their plan sponsor clients more than they reimburse pharmacies.

1. Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers. 

. January 14, 2025. Accessed January 16, 2025. 

https://www.ftc.gov/system/files/ftc_gov/pdf/PBM-6b-Second-Interim-Staff-Report.pdf

2. FTC Releases Second Interim Staff Report on Prescription Drug Middlemen. 

https://www.ftc.gov/news-events/news/press-releases/2025/01/ftc-releases-second-interim-staff-report-prescription-drug-middlemen

3. Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. 

. July 9, 2024. Accessed January 16, 2025. 

https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf

4. FTC Releases Interim Staff Report on Prescription Drug Middlemen. 

https://www.ftc.gov/news-events/news/press-releases/2024/07/ftc-releases-interim-staff-report-prescription-drug-middlemen

CVS Caremark, Express Scripts, OptumRx made more than $7.3 billion in revenue, with markups as high as thousands of percent. 

FTC Report Finds Big Three PBM Mark Ups for Specialty Generics Generated Billions

It could be argued that the demand for glucagon-like peptide-1 (GLP-1) receptor agonist medications such as semaglutide (Ozempic or Wegovy, both of which made the Centers for Medicare & Medicaid Services’ latest list of Part B and D drugs to be covered under this plan for price negotiations

) and tirzepatide (Mounjaro or Zepbound) has grown exponentially in the United States.

Approximately 6% of the US population reports currently taking a GLP-1 receptor agonist, although the proportion of people who report being told by a physician that they have overweight or obesity nears 1 in 5.

 However, despite these numbers, the Centers for Disease Control and Prevented notes that 73.6% of the US population has overweight or obesity.

 Many may remember that GLP-1 receptor agonists had been previously approved for the treatment of type 2 diabetes, but that has since changed; more recent clinical trials have been demonstrating that this drug class has been effective toward treating weight management and cardiovascular disease prevention, resulting in FDA approving these indications.

Keeping this in mind, those individuals with obesity but not diabetes represent a smaller subgroup. A cohort study published in 

 sought to explore this further by taking a deeper dive into the factors that are associated with semaglutide initiation in these specific individuals. What exactly influences their likelihood of receiving this form of obesity treatment?

In analysis that occurred from from February to November 2024, the retrospective observational study pulled data from the Merative MarketScan Commercial Claims and Encounters database from the June 5, 2020, through Dec. 31, 2022 timeframe. Adults in this database are 18 years of age or older, with a first diagnosis of obesity in an outpatient or inpatient setting between June 5, 2021, and July 1, 2022.

Further, in order to be included in the study, the 97,456 selected individuals were to have not been on any prior anti-obesity medication, GLP-1, no bariatric surgery, or not diabetes-related claim in the 12 months before obesity diagnosis, and continuous enrollment in the 12 months before and six months after the obesity diagnosis.

Overall, 58,124 individuals (59.6%) were female, 26,582 (27.3%) were aged 45 to 54 years, 49,390 (50.7%) were covered by their preferred provider organization plans, and 50,705 (52.0%) lived in the South. Out of the total sample size, 1,963 (2.0%) began semaglutide within six months of their initial obesity diagnosis. The random forest model had an area under the receiver operating characteristic curve of 0.71 (95% confidence interval or CI, 0.69-0.74).

Shapley Additive Explanations—a method of explaining how machine learning models make predictions—recognized various exposures, including sex, use of antidepressants, and the industry that the employer operates in. In the logistic regression model, the top 20 factors were used, which found significant associations with semaglutide initiation, including being female (adjusted odds ratio [aOR], 2.30; 95% CI, 2.05-2.58), use of specific medication classes, such as antidepressants (aOR,1.62; 95% CI, 1.46-1.78), and being covered by a point-of-service plan (aOR, 1.78; 95% C, 1.42-2.22).

The study investigators concluded that, “In this retrospective observational cohort study of commercially insured individuals with obesity and without diabetes, we identified sociodemographic, healthcare, and clinical factors associated with semaglutide initiation within six months after obesity diagnosis using a novel machine learning approach. The associations of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation.

“These findings suggest that inequities persist in medication access in this understudied subgroup, and further research should investigate factors associated with GLP-1 receptor agonist use in those with public payer plans, as well as whether concurrent use of common medications impacts effectiveness.”

1. Saraceno N. Headlined by Ozempic, Medicare Reveals Second Round of Drugs Selected for Price Negotiations. 

. January 17, 2025. Accessed January 22, 2025. 

https://www.pharmaceuticalcommerce.com/view/medicare-drug-price-negotiations

2. Montero A﻿, Sparks G﻿, Presiado M﻿, Hamel L﻿. KFF health tracking poll May 2024: the public’s use and views of GLP-1 drugs. KFF. Published May 10, 2024. Accessed May 21, 2024. 

https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-may-2024-the-publics-use-and-views-of-glp-1-drugs/

3. National Center for Health Statistics. Obesity and overweight. Centers for Disease Control and Prevention. Updated October 25, 2024. Accessed December 5, 2024. 

https://www.cdc.gov/nchs/fastats/obesity-overweight.htm

4. Lincoff AM﻿, Brown-Frandsen K﻿, Colhoun HM﻿, et al; SELECT Trial Investigators. Semaglutide and cardiovascular outcomes in obesity without diabetes. 

5. Podolsky MI, Raquib R, Shafer PR, Hempstead K, Ellis RP, Stokes AC. Factors Associated With Semaglutide Initiation Among Adults With Obesity. 

What factors influence their likelihood of receiving this form of obesity treatment?

The Association Between Semaglutide Initiation and Obese Individuals Without Diabetes

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.

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

Andy Studna

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