Medicine Archives - Page 5 of 5

Fail-First Policies Are Harming Patients

Step therapy, also known as “fail first,” is a tool used by health plans to control spending on patients’ medications.

Tackling Patient-Related Challenges Along the Pharma Supply Chain

Many would agree that our inclination toward picking a career is often inspired by some form of epiphany—a realization that

A Further Examination of Pharmacy Benefit Managers

In this exclusive PC Podcast interview, Brandon Newman, Xevant’s CEO and founder, explores: The implications of the Inflation Reduction Act’s

Who Moved My Prescription? Part III

In this third installment of my “Who Moved My Prescription?” I provide the baseline framework to help manufacturers and pharmacies

Today’s Most Promising Therapeutic Areas for Dealmaking

PC: Which therapeutics settings, or technology/platform areas, are you seeing the most M&A and partnering activity at the moment? Tritschler:

What Will Change in the Pharma Industry Look Like?

The pharmaceutical industry is rapidly approaching a breaking point with its current pharmacy benefit manager (PBM) model. Drug list prices

Challenges Surrounding the Medicare Shared Savings Program

Image Credit: Adobe Stock Images/LemauStudio.com Affordable care organizations (ACOs) consist of physicians, hospitals, and other healthcare providers who voluntarily provide

In Search of the ‘Bad Guy’

Fighting for patient affordability doesn’t necessarily require a scapegoat.

Reducing Costs and Increasing Accessibility of ADCs & Cell and Gene Therapies

Antibody drug conjugates and cell and gene therapies offer significant therapeutic promise, but their production costs can be sky high.

Various Vaccine Clinical Trials by Moderna Move on to Later Stages

Image Credit: Adobe Stock Images/Diy13.com At its Vaccines Day event, Moderna revealed various clinical and program updates concerning its mRNA

Leveraging Digital Tools to Optimize Manufacturing Processes

As drug discovery and clinical development pipelines accelerate, traditional manufacturing methods are struggling to keep pace. How can biopharma companies

Does the Passing of a No Behavioral Health-Cost Sharing Law Have Any Bearing on Spending?

Image Credit: Adobe Stock Images/ShubbyStudio.com In the United States, one of several public health obstacles is the underuse of care

New York City, Los Angeles Will Now Offer Amazon Pharmacy Same-Day Delivery

Image Credit: Adobe Stock Images/WinNondakowit.com Amazon Pharmacy—riding the momentum of the news that Eli Lilly’s weight loss drug Zepbound can

Adrianna Nava Discusses Goals of the NAHN

PC: Could you describe the goal of the NAHN? Nava: We actully have two missions. The first one is to

IATA, Pharma.Aero Team Up to Improve Association’s CEIV Pharma Program

Image Credit: Adobe Stock Images/Bomoge.pl.com The International Air Transport Association (IATA) and Pharma.Aero, a platform that helps provide the safe

John Hoffman Discusses the Inflation Reduction Act and Current Advocacy Efforts

PC: How has the Inflation Reduction Act benefited your advocacy efforts? Hoffman: I like to refer to it as the

Tiara Green Discusses Challenges of Patient Assistance Organizations

PC: You’ll be a part of the “Ask Me Anything Session with Leading Charitable Foundations” session. Without giving too much

Teaming Up on Patient Assistance

PAP 2024 session, “Collaborating for Patient Assistance Excellence—Insights from Patients, Manufacturers, and Pharmacy Fulfillment Providers.” March 21, 2024. PAP 2024,

More Studies by Columbia Cancer Researches Retracted, Vista.ai Appoints MedTech Veteran as CEO & more

Check out our conference coverage of Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East UCB’s Women

Amy Niles Discusses Goals of the PAN Foundation

PC: Could you describe PAN Foundation’s main objective? How does the non-profit assist with patients’ out-of-pocket costs? Niles: The PAN

Lonza Purchases Roche Biologics Manufacturing Site in California for $1.2 Billion

Image Credit: Adobe Stock Images/Kv_San.com Lonza, a contract development and manufacturing organization (CDMO), will be purchasing Genentech’s large-scale biologics manufacturing

The Glass is Half Full

PAP 2024 session, “Finding the Silvering Lining—Hear, See, and Feel the Influence of Patient Assistance.” March 21, 2024. PAP 2024,

Should Copay Accumulators be Banned? Pharmatizing AI & more

Check out our conference coverage of Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East Pharmatizing AI

Hubs East 2024: Leveraging Digital Hubs

Hubs East 2024 session, “Leveraging Digital Hubs to Improve Retail & Specialty Lite Access, Affordability, and Adherence.” March 20, 2024.

Monique French Discusses Effective Ways to Engage Patients, Caregivers, and Advocacy Groups

PC: In your opinion, what are the most effective ways to engage patients, caregivers, advocacy groups? French: I think the

Michael Galarraga Discusses “The State of Patient Access and Affordability”

PC: What points did you raise during your “The State of Patient Access and Affordability” session? Galarraga: Some of the

Merck’s 21-Valent Pneumococcal Conjugate Vaccine Shows Efficacy Across Various Serotypes

Image credit: Bernard Chantal | stock.adobe.com Merck’s novel adult-specific 21-valent pneumococcal conjugate vaccine V116 demonstrated positive results in multiple clinical

Reading the Tea Leaves on Recent Surge in Pharma Dealmaking

PC: What’s your feeling on the recent uptick in biopharma M&A and biotech IPO activity as far as influencing and

FDA Approves Xhance, Optinose’s Treatment for Adults with Chronic Rhinosinusitis Without Nasal Polyps

Image Credit: Adobe Stock Images/labden Optinose announced that the FDA has approved Xhance as the first medication for adults with

Exploring the Future of Rental Cold Storage in Life Sciences

March 14th 2024 Article From research and development to the clinical trials phase, pre-conditioning gel packs and PCMs prior to

Celebrity Endorsements in Ozempic, Enhancing Transparency Between Patients and Researchers & more

New Technologies Enhancing Transparency Between Patients and Researchers In this Applied Clinical Trials video interview, Julia Lakeland, Chief Product Officer,

LSPedia Signs Drug Supply Chain Security Act Compliance Deal with Premier, Inc.

Image Credit: Adobe Stock Images/LeoWolfert.com LSPedia, a provider of software-as-a-service (SaaS) traceability solutions for the pharmaceutical industry, has been granted a

Getting the Lay of the Land After a Banner Year for Biosimilars

Fran Gregory, PharmD, MBA. Vice President of Emerging Therapies at Cardinal Health. More than eight years after the first biosimilar

Elranatamab Maintains or Improves Symptoms of Multiple Myeloma Patients, AI Assistant for Security Products & more

Benefits and Limitations of Strategies Used to Improve Clinical Development Productivity In this Pharmaceutical Executive video interview, Murray Aitken, Executive

The Case for Domestic Sourcing to Establish Reliable Pharmaceutical Supply Chains in the United States

Image credit: Bernice | stock.adobe.com Global supply chain issues are not exclusive to the pharmaceutical industry. However, this is an

Cancer’s Financial Burden Being Felt Worldwide

Image Credit: Adobe Stock Images/M+Isolation+Photo.com According to commentary published in the Canadian Medical Association Journal,1 an estimated 33%–40% of patients

FDA Expands Approval of Mirum’s Livmarli for Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis

Image Credit: Adobe Stock Images/Olivier Le Moal Mirum Pharmaceuticals announced that the FDA has approved Livmarli (maralixibat) for the treatment

Advanco Opens New Office in Singapore

Image Credit: Adobe Stock Images/DiegoMaravilla.com In order to meet customer demand, advanco, a pharmaceutical track-and-trace solutions provider, is opening an

Robert P. Mauch to Become CEO in October 2024

Robert P. Mauch, PharmD, PhD, Cencora Steven H. Collis will retire as president and CEO of Cencora, shifting to the

Older Adults’ Experience with Opioid Use, Deprescribing

Image Credit: Adobe Stock Images/PerfectLab.com Data show that 30% of Americans 65 years of age or older have experienced chronic

Adopting New Manufacturing Technologies

Groovy Singh, CEO, Bright Green Corporation Pharmaceutical Commerce: Could you tell me about Bright Green Corporation? Groovy Singh: Bright Green

Taking a Closer Look at Medicare Part D’s Rising Drug Coverage Restrictions

Image Credit: Adobe Stock Images/Volgariver.com The purpose of Medicare Part D is to help beneficiaries with assistance in affording their

Incyte’s Phase II Study for Opzelura Returns Promising Results in Adult Patients

Image Credit: Adobe Stock Images/KristinaBlokhin.com Incyte has revealed new results from a conducted Phase II study that measured the safety and

Rite Aid Enters into APA, S.E.C. Investigates OpenAI & more

Image Credit: © Romolo Tavani | AdobeStock_133004631 How the Pandemic Changed the Way Pharma Looks at Data Integrity in 2024

Almac Group Grows Northern Ireland HQ, Welcomes New Facilities

Image Credit: Almac Group In order to meet demand for commercial manufacturing, packaging, and peptide production services, the Almac Group,

Lilly’s New Campaign Challenges Misperceptions About Obesity Care, Challenges Facing Broader Adoption of Novel Cell and Gene Therapies & more

The Biggest Challenges Facing Broader Adoption of Novel Cell and Gene Therapies In this Pharmaceutical Executive video interview, Murray Aitken,

US Government Considers Banning Dealings with WuXi AppTec, Affiliates

Image Credit: Adobe Stock Images/JimGlab.com The US Senate’s homeland security committee has decided to proceed with the approval process for

The Biggest Impacts on the Future of the Biotech Industry

What emerging scientific advancements do you foresee having the biggest impact on the future direction of the biotechnology industry? We

Is There a Correlation Between Medical Debt and Health Status?

Image Credit: Adobe Stock Images/Volgariver.com Many would agree that when it comes to healthcare in the United States, high out-of-pocket

AstraZeneca Intends to Make $831 Million Financial Commitment in the UK

AstraZeneca’s Speke site. Image Credit: Gov. UK AstraZeneca is planning to invest $831 million (£650 million) in the UK life

Navigating the Current Funding Slowdown While Securing Capital

What specific strategies can new biotech companies adopt beyond outsourcing to navigate the current funding slowdown while securing the capital

Air Pollution Linked to Childhood Asthma, Four-Steps to Accelerate Study Start-up Cycles & more

Image Credit: © Андрей Трубицын | AdobeStock_345374024 Four-Steps to Accelerate Study Start-up Cycles Identifying KPIs, benchmarks, key data points, and

How Long Will the Current Slowdown in Biotech Investment Last?

With the increasing focus on supply chains, how do you see the balance between onshoring and outsourcing evolving in the

Tetanus Vaccine Now Facing Shortages

Image Credit: Adobe Stock Images/MargJohnsonVA.com The Centers for Disease Control and Prevention (CDC) has reported1,2 that the tetanus and diphtheria

Alamar Biosciences and ALZpath Announce Collaboration Centered on Furthering Alzheimer’s Disease Research

Image Credit: Adobe Stock Images/AkuAku.com In an effort to further progress neurodegenerative disease research, Alamar Biosciences, a precision proteomics company,

The Future of the Health Insurance Market Appears Stable

Image Credit: Adobe Stock Images/DeemerwhaStudio.com Despite ongoing challenges, the current US health insurance sector is being classified as stable and

Local Pharmacies on the Brink, People in MA Plans Experienced Delays in Accessing Care & more

Miha Creative | AdobeStock_522307877 Cencora’s Corey Ford Discusses the Future of the Inflation Reduction Act In an interview with Associate

Cencora VP of Reimbursement & Policy Insights Discusses Implications of the Inflation Reduction Act

PC: Recently, you hosted a webinar on the implications of the Inflation Reduction Act. Can you touch upon the main

Cencora’s Corey Ford Discusses the Future of the Inflation Reduction Act

PC: How do you believe the IRA will evolve over the next five to 10 years? Ford: There’s a lot

Amneal, Zambon Biotech Enter Exclusive European Licensing Agreement for Parkinson’s Disease Medication

Image Credit: Adobe Stock Images/Pixel-Shot.com Amneal Pharmaceuticals, Inc. has entered into an exclusive licensing agreement with Zambon Biotech SA, a

Systech Introduces Solution for Managing Pharma Supply Chain Exceptions

Image Credit: Adobe Stock Images/LeoWolfert.com Systech, a Markem-Imaje solutions brand that offers brand protection via packaging serialization, has released a

Examining the Impact of the COVID-19 Pandemic on Patient Portal Use

Image Credit: Adobe Stock Images/Woravut.com Many would agree that the COVID-19 pandemic revolutionized the future of healthcare, which, although being

Navigating Changes and Trends in the Pharmaceutical Supply Chain Post-DSCSA

Drug Supply Chain Security Act (DSCSA) compliance requirements took effect on November 27, 2023. The clock is now ticking on

The Connection Between Natural Disasters and the Rise in Psychotropic Medication Prescriptions

Image Credit: Adobe Stock Images/MyPhotoBuddy.com Over the past few years, wildfires in the United States have grown in prominence—especially on

A First-Hand Account of 3PLs

In this exclusive PC Podcast interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares: A general overview of how

Finding the Ideal Set of Oncology Employer Benefits

Image Credit: Adobe Stock Images/MonkeyBusiness.com When it comes to what employers are looking for on behalf of their employees, medical

Survey Reveals Americans’ Frustrations With the Healthcare System

MDVIP’s “Patient Frustration Index.” Image Credit: MDVIP According to a new survey from MDVIP, 61% of Americans are feeling that the

Does Food Insecurity Impact Adherence to Antihypertensive Medications?

Image Credit: Adobe Stock Images/Pixel-Shot.com In the United States, hypertension—also known as high blood pressure—affects nearly half of adults, accounting

Takeda, Biological E. Team Up to Provide Dengue Vaccine Access to Endemic Countries

Image Credit: Adobe Stock Images/Auimeesri.com Takeda and Biological E. Limited (BE), a pharmaceutical and biologics company, have decided to partner

The Perks of Medicare Advantage Versus Traditional Medicare

Image Credit: Adobe Stock Images/Drazen.com Medicare Advantage (MA) plans are often known for creating financial incentives, as the US Centers

First-in-Class Novel Therapy for Chronic Myelomonocytic Leukemia Granted FDA Orphan Drug Designation

Image credit: Tada Images | stock.adobe.com Immune-Onc Therapeutics’ novel therapy IO-202 has been granted orphan drug designation by the FDA to

Pharma Pulse for February 23, 2024

Dupixent sBLA Gets FDA Priority Review for Treatment of COPD With Type 2 Inflammation

Image credit: peterschreiber.media | stock.adobe.com The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) submitted

Fortrea Grows Its Non-Commercial Specialty Pharma Offering

Image Credit: Adobe Stock Images/Chesky.com Fortrea, a contract research organization (CRO), has opened its newly expanded 40,000 square-foot, non-commercial specialty

World Health Organization Grants Prequalification to Typhoid Conjugate Vaccine

Image credit: tashatuvango | stock.adobe.com The World Health Organization (WHO) has granted SK bioscience with prequalification (PQ) certification for its

Identifying Trends Surrounding the Use of In-House Pharmacies for High-Cost Drugs

Image Credit: Adobe Stock Images/AndrzejTokarski.com In the United States, healthcare organizations are pushing to vertically integrate various components of the

Analyzing PCSK9 Inhibitor Use in Adults With Cardiovascular Disease

Image Credit: Adobe Stock Images/Dr_Microbe.com In the United States, atherosclerotic cardiovascular disease (ASCVD) continues to be the leading cause of

Investigating Trends in the Pharmaceutical Research & Development Space

Image Credit: Adobe Stock Images/DavidUndderriese.com The healthcare industry often relies on the success of biomedical advances, which peaked exponentially during

LSPedia Introduces New Traceability Solution

Image Credit: Adobe Stock Images/Hanzala.com LSPedia, a provider of software-as-a-service (SaaS) traceability solutions for the pharmaceutical industry, has officially launched

Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure

Image Credit: Adobe Stock Images/AfricaStudio.media.com Empagliflozin is a medication indicated for glucose control in patients with type 2 diabetes, but

FDA Approves Tecvayli at Reduced Dosing Frequency for Relapsed/Refractory Multiple Myeloma

Image credit: Saiful52 | stock.adobe.com. The FDA has approved Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab-cqyv)

Opthea Hires New Chief Medical Advisor

Arshad M. Khanani, MD, MA, FASRS. Image Credit: Opthea Limited Opthea Limited, a clinical-stage biopharma company that creates novel therapies

Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review

Image credit: Dr_Microbe | stock.adobe.com. The FDA has granted Priority Review status to Bristol Myers Squibb’s supplemental new drug application

Affordable Solutions Are Available to Self-Insured Plan Sponsors

Image credit: adragan | stock.adobe.com. Prescription drug pricing has become a major concern in the United States, with patients and

FDA Approves First One-Time, Individualized T Cell Therapy for a Solid Tumor

Image credit: Christoph Burgstedt | stock.adobe.com The FDA has granted accelerated approval to Iovance’s Amtagvi (lifileucel) for adults with unresectable

First Pulse Oximeter Available Without a Prescription is Cleared by the FDA

Image Credit: Adobe Stock Images/NewAfrica.com Earlier this week, Masimo announced the FDA clearance of the MightySat Fingertip Pulse Oximeter, representing

Artificial Intelligence May Accelerate Time to Determine Response to Treatment

Image credit: photon_photo | stock.adobe.com. Researchers are beginning to realize the potential of artificial intelligence to predict the safety and

FDA Grants Full Approval to Tepmetko for Metastatic NSCLC Subtype

Image credit: iDoPixBox | stock.adobe.com. EMD Serono, Merck KGaA’s biopharmaceutical business, scored a traditional approval for Tepmetko (tepotinib) to treat

Three Areas to Drive Supply Chain Value

There is one certainty about health care supply chain in 2024: smart executives will challenge the status quo and think

FDA Approves First Treatment for Multiple Food Allergies in Adults, Children

Image credit: bit24 | stock.adobe.com. Food allergy. Allergic food on wooden background. The FDA has approved an expanded indication for

DHL Supply Chain Invests $200M Toward Expanding its Life Sciences and Healthcare Services

Image Credit: DHL Supply Chain DHL Supply Chain, a logistics company that operates within Deutsche Post DHL Group, has made a

Using Machine Learning to Predict Cancer Treatment Effectiveness

Image Credit: Adobe Stock Images/Nobeastsofierce.com Rapid cell proliferation or spreading is a staple of cancer, especially when it is combined

Aurlumyn Gets First FDA Approval for a Severe Frostbite Medication

Image credit: Szymon Bartosz | stock.adobe.com The FDA announced that it has officially approved Actelion Pharmaceuticals’ Aurlumyn (iloprost) injection, the

FDA Grants Priority Review to Augtyro for NTRK-Positive Solid Tumors

Image credit: peterschreiber.media | stock.adobe.com. Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) has been granted Priority

Strategizing High-Wire, Multi-Indication Launches

Left to right: Jeremy Dann and Reena Patel For a given product, a market access strategy must start with clear

Analyzing State-Based Legislation Surrounding Medical Freedom, Stem Cell Procedures

Image Credit: Adobe Stock Images/Rost9.com Given the severity of terminal and chronic diseases, the regulatory agencies that are responsible for

How AI Can Help Solve Drug Shortage Issues

What’s causing drug shortages right now? So, the causes for drug shortage are several, one of them being high demand

Can Lower Out-of-Pocket Costs Help Improve Diabetes Patients’ Short-Term Health?

Image Credit: Adobe Stock Images/Neirfy.com Over the past 20 years, type 2 diabetes—a disease in which the pancreas has trouble

What Goes into Planning LogiPharma Europe?

From April 16-18, the 24th edition of LogiPharma Europe takes place at the Centre de Congrès de Lyon in France.

Samgsung Biologics Announces Partnership With LegoChem Biosciences to Advance Development of Antibody-Drug Conjugates

Image credit: Juan Gärtner | stock.adobe.com Samsung Biologics, a contract development and manufacturing organization (CDMO), and LegoChem Biosciences, a biotech

Resource Label Group Introduces New Business Unit

Image Credit: Adobe Stock Images/DiegoMaravilla.com Resource Label Group, LLC (RLG), a provider of label and packaging solutions including pressure sensitive

Forecast Predicts Generic Drug Market Will Grow Upwards of $175B Over the Next Three Years

Image Credit: Adobe Stock Images/Jezper.com The generic drug market is expected to show significant growth in the coming years. At

Study Highlights the Value of Patient Support Programs

Image Credit: Adobe Stock Images/Synthex.com When pharmaceutical companies release new drugs into the market, they can choose to provide patient

Erectile Dysfunction Meds Could Be Associated With Lowering Alzheimer’s Disease Risk

Image Credit: Adobe Stock Images/Zerbor.com All-cause dementia is growing in prominence across the globe, being estimated to impact 57 million

AstraZeneca Unveils New Cell Therapy Manufacturing Facility in Maryland

Image Credit: AstraZeneca AstraZeneca will be financially committing $300 million toward a state-of-the-art facility in Rockville, MD, a plant that

BridgeBio Pharma Receives FDA Acceptance of New Drug Application Filing for Acoramidis

Cardiac muscle fibers in the myocardium. Image Credit: Adobe Stock Images/JosLuis.com The FDA has accepted the filing of BridgeBio Pharma,

Future of Personalized Medicine Hinges on Pharma Executives Revolutionizing Business Models

Kostja Paschalidis, service design lead, Beyond Estelle Ricoux, director of product and strategy for Europe, Beyond Every day, new advancements

Novel ADC in Trials for Ovarian, Fallopian Tube, Primary Peritoneal Cancers Gets FDA Fast Track Designation

Image credit: Dr_Microbe | stock.adobe.com The FDA has granted Fast Track designation to an application from BioNTech SE and Duality Biologics Co., for

Merck Animal Health Inks $1.3 Billion Deal for Elanco’s Aqua Brand

Image Credit: Adobe Stock Images/SiberianArt.com Merck Animal Health, also known as MSD Animal Health outside of the United States and

FDA Grants Fast Track Designation to Cancer Vaccine for Malignant Pleural Mesothelioma

Mesothelial cells in body fluid sample. Image credit: toeytoey | stock.adobe.com The FDA has granted Fast Track Designation to Ultimovacs

The Current State of Pharma 3PLs and Future Outlook

Third-party logistics (3PL) providers are often called upon by pharmaceutical manufacturers to help address the challenges surrounding the movement and

Afamitresgene Autoleucel Granted FDA Priority Review for Advanced Synovial Sarcoma

Image credit: MdBabul | stock.adobe.com The FDA has granted Priority Review status to Adaptimmune Therapeutics’ biologics license application (BLA) for

Allarity Loses Rights to Cancer Drug Dovitinib After Missing Payments to Novartis

Image credit: Taljat | stock.adobe.com Novartis is terminating its agreement with Allarity Therapeutics, Inc. for the exclusive global rights to develop

The Path for Prescription Drug Sales

Evaluate, a consulting and data intelligence provider for the life sciences sector, releases a variety of reports through the course

Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages

Image credit: Peter Hansen | stock.adobe.com Sanofi and manufacturing partner AstraZeneca have announced a new reservation program to address the

A Comparison of Prescription Drug Availability

Image Credit: Adobe Stock Images/SteveCukrov.com Bringing a potential new drug to market is no simple feat, and it requires years

A Pharma Pricing and Agreements Primer in Today’s Complex Landscape

In the pharmaceutical sector, pricing models are complex, involving multiple stakeholders, such as healthcare providers (HCPs), insurers, and government agencies.

Forecasting the Effect of Out-of-Pocket Cost Changes for HIV Medication

Image Credit: Adobe Stock Images/Shakzu.com In order to reduce the risk of contracting HIV, healthcare providers (HCPs) often prescribe oral

DSCSA 2024 or 2023 Déjà Vu?

Nov.27, 2023, was the date that the US pharmaceutical supply chain fully implemented all stages of the Drug Supply Chain

Biogen Discontinues Maligned Alzheimer Disease Treatment Aduhelm

Image credit: Artur | stock.adobe.com Biogen Inc. has announced it will discontinue the development and commercialization of its controversial Alzheimer disease

FDA Grants Priority Review to Pair of Applications for Breyanzi for R/R Follicular Lymphoma, Mantle Cell Lymphoma

Image credit: wladimir1804 | stock.adobe.com The FDA has granted Priority Review to a pair of supplemental Biologics License Applications (sBLA)

A Behind-the-Scenes Look at Drug Price Markups

Image Credit: Adobe Stock Images/MaxZolotukhin.com One major component of Pharmaceutical Commerce’s coverage revolves around drug pricing in the pharma industry.

Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models

Pharma Commerce: Recently, CVS and Express Scripts have announced plans to set up pricing models that follow Mark Cuban’s drug

The Association Between Cannabis Legalization and Opioid Overdoses

Image Credit: Adobe Stock Images/KimberlyBoyles.com In the United States, the opioid epidemic has been an ongoing crisis taking place over

Adverse Event Reports Linked to Counterfeit Ozempic on the Rise

Image credit: Natalia | stock.adobe.com According to an article published by Reuters, three US residents experienced hypoglycemia last year after

Challenges and Benefits of Implementing IDMP in the Pharmaceutical Industry

Image credit: Mike Mareen | stock.adobe.com The pharmaceutical industry is characterized by a multitude of products with varying complexities and

The Promise of Long-Acting Injectables

Thom Stambaugh, RPh, President, Specialty and Chief Clinical Officer, Altruix In the past decade, the opioid crisis in the United

The Twists and Turns in Biopharma Dealmaking: 2024 Trends

Spikes and valleys in M&A and dealmaking activity have been fairly routine and expected occurrences over the years in the

GLP-1 Agonists Could Be Key in Reducing Severe Liver Disease for Type 2 Diabetes Patients

Image credit: Rasi | stock.adobe.com Glucagon-like peptide-1 (GLP-1) receptor agonists may help lower the risk of developing cirrhosis and liver cancer

Does Patient Priorities Care Result in Better Outcomes for Patients?

Image Credit: Adobe Stock Images/Siphosethu F/peopleimages.com It may come as no surprise that older adults who have multiple chronic conditions

Examining the Liability Risk Surrounding Artificial Intelligence Tools in the Healthcare Environment

The use of artificial intelligence (AI) in the healthcare space has created excitement over the potential of endless opportunities, but

Dupixent Approved for Expanded Indication in Children Under 12 Years With Eosinophilic Esophagitis

Image credit: Yurii Kibalnik | stock.adobe.com The FDA has approved an expanded indication for Regeneron Pharmaceuticals’ and Sanofi’s Dupixent (dupilumab) to treat

FDA to Require Boxed Warning Labels on CAR T-Cell Therapies for Secondary Cancer Risks

Image credit: LASZLO | stock.adobe.com On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to

Complying With the DSCSA

In this exclusive PC Podcast interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into: The valuable lessons he’s

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

Image Credit: © Aerial Mike – stock.adobe.com Prilenia Therapeutics B.V. has announced it will present clinical data supporting a future

Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs

Image Credit: Adobe Stock Images/Fotomek.com Simply put, generic drugs are encountered daily at one’s local pharmacy, and are known to

Opdivo Plus Yervoy Shows Significantly Improved Progression-Free Survival in Metastatic Colorectal Cancer

Image credit: Dr_Microbe | stock.adobe.com The combination of Bristol Myers Squibb’s Opdivo (nivolumab) with Yervoy (ipilimumab) showed significant improvements in

Satri-Cel CAR T-Cell Therapy Shows Promising Safety, Efficacy in Gastric, Pancreatic Cancer

Image credit: AIGen | stock.adobe.com CARsgen Therapeutics Holdings Limited, an organization working with chimeric antigen receptor (CAR) T-cell therapies for

FDA to Evaluate Premarket Approval Application for TTFields in Non-Small Cell Lung Cancer

Image credit: appledesign | stock.adobe.com The FDA has accepted Novocure’s premarket approval (PMA) application for the addition of tumor-treating fields

In the Shadows of the Drug Affordability Debate, Patients Pay the Ultimate Price

Image credit: suyujung | stock.adobe.com In the first year of our “Prescription for Better Access” podcast, our guests have represented

Radioligand Therapy Found to Improve Survival, Disease Progression in Advanced GEP-NETs

Image credit: Design Cells | stock.adobe.com Phase III trial data for Novartis’ Lutathera (INN: lutetium [177Lu] oxodotreotide/USAN: lutetium Lu 177 dotatate)

How Financialization Has Impacted the US Healthcare System

Image Credit: Adobe Stock Images/ValeriLuzina.com There has been a long-standing debate as to what the profit motives for the US

Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma

Image credit: Matthieu | stock.adobe.com The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma

An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group

Nicholas Saraceno: What may be the potential driving force behind recent moves by PBMs like CVS and Express Scripts to

An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group

Nicholas Saraceno: Do you believe the news of Eli Lilly’s digital platform will cause a shift in manufacturers bypassing middlemen

Antibiotic for Uncomplicated Urinary Tract Infections Granted FDA Priority Review

Image credit: Vitalii Vodolazskyi | stock.adobe.com Utility Therapeutics, a UK-based biotechnology company, announced that the FDA has granted priority review

HyQvia Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance

Image credit: Chinnapong | stock.adobe.com The FDA has approved Takeda’s HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase]

The Importance of Drug Supply Chain Security

Image Credit: Adobe Stock Images/9dreamstudio.com The US pharmaceutical supply chain is an extensive one, with drug wholesalers, manufacturers, distributors, and

The Benefits and Privacy Concerns in Utilizing Artificial Intelligence for Early Detection of Breast Cancer

Image Credit: Adobe Stock Images/Vasyl.com The use of artificial intelligence (AI) is transforming care for breast cancer, which has the

Zoryve Produces Promising Results in Dermatologic Conditions Across Recent Trials

Image credit: chaphot | stock.adobe.com Arcutis Biotherapeutics recently shared significant findings from a pair of clinical trials showing the efficacy

Air Cargo on the Rise in November

According to data released by the International Air Transport Association (IATA) for November 2023, air freight numbers point to the

Pharmaceutical Contract Manufacturing Market Expected to Hit $140 Billion by 2030

Image Credit: Adobe Stock Images/Alexej According to a new report by Roots Analysis, the global pharmaceutical contract manufacturing market is

Examining the Rise of Telehealth During COVID-19

Image Credit: Adobe Stock Images/Jypix.com Although telehealth has been a more affordable and convenient option at patients’ disposal for quite

Neuralace Medical’s Axon Therapy Granted FDA Clearance for Diabetic Neuropathy

Image credit: AIGen | stock.adobe.com The FDA has granted clearance to Neuralace Medical’s Axon Therapy, which is a noninvasive treatment

Emergent BioSolutions Awarded Contract to Supply US Military With Anthrax Vaccine

The US Department of Defense awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all

Investigational Ovarian Cancer Drug Granted FDA Fast Track Designation

Image credit: blueringmedia | stock.adobe.com The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate

The Future of Employer Coverage for Glucagon-Like Peptide 1 Receptor Agonists in Weight Loss

Image Credit: Adobe Stock Images/9dreamstudio.com Glucagon-like peptide 1 receptor agonists (GLP-1s) have been a staple of the pharmaceutical industry for

Reimbursement-Related Analytics and Reporting

Image credit: tadamichi | stock.adobe.com Given the importance of reimbursement to any pharmaceutical brand, comprehensive reporting and analytics must be

FDA to Review Application for Generic Lutathera for Gastroenteropancreatic Neuroendocrine Tumors

Image credit: THITIPORN | stock.adobe.com The FDA has accepted Lantheus Holdings, Inc’s abbreviated new drug application (ANDA) for Lutetium Lu

FDA Grants Fast Track Designation to SLS009 for Relapsed/Refractory AML

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for

Shorla Oncology Announces FDA Acceptance of NDA for Novel Treatment for Breast, Ovarian Cancer

The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder

Vaccine Sales Drop for Moderna in 2023 With Growth Expected by 2025

At the 42nd annual JP Morgan Healthcare Conference, Moderna said new product launches later this year will return the company

Advances in Plant-Made Vaccine Technology

Review article explores the latest developments surrounding expression and purification strategies. With infection viruses—such as severe acute respiratory syndrome coronavirus-2

Merck Highlights Robust Oncology, Hematology Pipeline With Four Agents in Phase III Trials

Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell

Novartis Opens New Radioligand Therapy Manufacturing Facility in Indianapolis

In the midst of being approved for commercial manufacturing of Pluvict, the 70,000 square-foot site was built specifically to accommodate

Electronic Health Record Messaging Patterns of Healthcare Providers

Electronic health record messaging network found to improve communication and lead to better medication adherence. According to the Joint Commission,

Novel Treatment for Non–Muscle Invasive Bladder Cancer Granted FDA Fast Track, Breakthrough Therapy Designation

Cretostimogene grenadenorepvec is a novel, intravesically delivered oncolytic immunotherapy under evaluation for the treatment of patients with high-risk Bacillus Calmette-Guérin

Diversity Trends in Health Professions Programs

Study examines the parallels between doctorate students and the US population. One concern that has been consistently raised in the

Strategic Insight and Forecasting: From Pipeline to Pharmacy

How pharma companies can be successful in financial forecasting, including why these forecasts should be powered by a patient-based approach.

World Courier Opens Three New US Transport Stations

The latest move expands the company’s storage capacity and cold chain capabilities. Cencora’s World Courier, a specialty logistics provider, intends

Creating a Future-Ready Chemicals and Materials Lab Vital for Growth

Teams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D

DE&I Within the Life Sciences Space

The conference hosts a diversity, equity, and inclusion (DE&I) Summit featuring personal insights and experiences. Day 3 of the Trade

An Interview with Bill Trombetta, PhD, Professor Emeritus, St. Joseph’s University

Pharma Commerce: What are the keys to successfully navigating what you describe as “the coming perfect storm” in healthcare? Trombetta:

FDA Approves Treatment to Lower Relapse in High-Risk Neuroblastoma

Eflornithine (Iwilfin) is indicated to lower the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who showed

An Interview with Douglas Bock of Archbow Consulting

Partner for Archbow Consulting discusses the conference, the IRA, and specifics of PAP business rules In an interview with Pharma

Pharma.Aero, Cool Chain Association Partner Up on Pharmaceutical Shipping

MoU aims to align the pharmaceutical and cold chain sectors by boosting operations. Pharma.Aero—a link that provides the safe transportation

FDA Approves HIF-2α Inhibitor for Patients With Advanced Renal Cell Carcinoma

The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared

Unlocking Pharma 4.0 Through Edge Computing

Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their

Top 3 Most-Read Supply Chain Logistics Pieces of the Year

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers. The top 3 pieces

IRA—All the Things Beyond Price Negotiations That Will Impact Your Business

Breakout session summarizes key areas that will affect all aspects of the industry. On Day 1 of the Trade &

Top 3 Podcast Episodes of the Year

This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance. With 10 episodes having gone live this

ACG Inspection Presents New VRS

Cloud-based service to address verification of saleable returns under the latest DSCSA regulations. In the midst of the latest Drug

FDA Approves Zoryve Topical Foam for Seborrheic Dermatitis

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of

Novel Vaccine Against Respiratory Syncytial Virus Shows Significant Efficacy

Moderna previously filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease and acute respiratory

FDA Approves Expanded Indication for Adbry in Atopic Dermatitis

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic

FDA to Review BLA for CSL Behring’s Novel Treatment for Hereditary Angioedema

If the FDA approves garadacimab, it would be the first approved hereditary angioedema therapy that targets activated FXIIa. The FDA

Treating Psoriasis While Providing Patient Support

Camille Lee discusses the impact of commercial availability of Bimzelx for the treatment of moderate-to-severe plaque psoriasis in adults, along

Biologics License Application for Xolair Granted FDA Priority Review for Food Allergies

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to

How Healthcare Economics Outcomes Evidence Can Pave the Way for Digital Therapeutics

In the face of chronic disease, DTx have the opportunity to provide a lifeline to patients. The world’s population is

Mitigating Bias in Healthcare Algorithm Development

A panel designs a conceptual framework in an effort to limit partiality. Healthcare algorithms are designed to use mathematics not

Filsuvez Topical Gel Approved by FDA for Wounds Associated With Epidermolysis Bullosa

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months

Biologics License Application for 21-Valent Pneumococcal Vaccine Granted FDA Priority Review

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA)

Jemperli Combination Significantly Improves Survival in Primary Advanced, Recurrent Endometrial Cancer

Jemperli has shown potential both as a monotherapy and in combination with standard of care and future novel cancer therapies,

FDA Approves Padcev Plus Keytruda for Urothelial Cancer

The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for