Pharma Manufacturing

JUNE 17, 2025

Magazine ENEWS SUBSCRIBE WEBINARS PODCASTS EBOOKS ABOUT US Edit submissions Media kit Innovation Awards Articles Flow state: The evolving shape of continuous manufacturing June 17, 2025 While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.

Dosage

Express Pharma

JUNE 19, 2025

Why this article? a practitioner’s perspective: Against this dynamic and high-stakes backdrop, Indian sterile manufacturers must now navigate a complex regulatory terrain. India’s sterile pharmaceutical manufacturing sector has made significant strides in aligning its infrastructure and operations with global regulatory expectations.

Documentation

Pharmaceutical Commerce

JUNE 18, 2025

Nicholas Saraceno is Pharmaceutical Commerce's Editor. How Recent Executive Orders Impact the Drug Pricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

Drug Pricing

Pharmacy Times

JUNE 4, 2025

The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.

Pharmaceutical Manufacturing

GMPSOP

JUNE 15, 2025

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. Hence, spores require complex treatment to remove them.

Pharmaceutical Manufacturing

European Pharmaceutical Review

APRIL 8, 2025

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. GMP Audits in Pharmaceutical and Biotechnology Industries.

Documentation

Pharmaceutical Commerce

JUNE 18, 2025

How Recent Executive Orders Impact the Drug Pricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

Specialty Pharmacies

Express Pharma

JUNE 20, 2025

Indian sterile manufacturers are well-positioned to lead not just in volume but in global trust if they move decisively from compliance to confidence. CALL-TO-ACTION The insights and observations throughout this article converge on a single imperative: the need for quality-led transformation. FDA oversight.

Documentation

Pharmacy Times

JUNE 23, 2025

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If REFERENCE Soefje SA.

Pharmacy Technician

Putting Patients First Blog

MAY 6, 2025

4 ,5 Millions of Americans rely on medicines that are manufactured outside the United States, particularly from close and longstanding allies such as Ireland, Switzerland, and the United Kingdomcountries whose regulatory frameworks for pharmaceutical manufacturing mirror the high standards enforced domestically.

Pharmaceutical Manufacturing

Pharmacy Times

JUNE 16, 2025

3,4 How this pricing model will be implemented and whether pharmaceutical manufacturers will be able to meet the expectations of the 2025 executive order, if upheld, is uncertain. The order states that if manufacturers are unable to meet the 30-day deadline, the secretary of the Department of Health and Human Services, Robert F.

Pharmacy Technician

Pharmacy Times

JUNE 8, 2025

This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceutical manufacturers, medication access programs, and industry representatives. In many cases, the pharmacist resolves the issue independently, escalating to the provider only when necessary.

Pharmacy Technician

Pharmaceutical Commerce

JUNE 17, 2025

link] Download Issue PDF Articles in this issue Bolstering Health Technology Assessment With the Help of AI Changing the PAP Model Building Intelligent Pharma Supply Chain Management with Real-World Data Policy Whiplash? Jeff Webber Key Takeaways Real-world data enhances medication safety and supply chain efficiency. References 1.

Health and Personal Care Stores

PharmaTech

AUGUST 1, 2025

The industry's dependence on geopolitical stability and predictable trade relationships is increasingly critical for global pharmaceutical manufacturing. Tariffs disrupt supply chains, impacting both finished products and raw materials, complicating compliance and cost forecasting. Share your voice!

Dosage

Pharmaceutical Commerce

JULY 31, 2025

tariffs on imports from Mexico, Canada, and China have disrupted the pharmaceutical industry, prompting reshoring discussions. We have evidence of foreign manufacturers cutting corners and having less than high-quality standards.”

Insurance Coverage and Processing

Pharma Marketing Network

JULY 9, 2025

Manufacturing Dependencies and Global Disruption Pharmaceutical manufacturing doesn’t operate within national borders. Pharma marketers can explore strategies highlighted in this Featured Article on post-crisis brand positioning. History suggests that the pharmaceutical industry is remarkably resilient.

Drug Pricing

Pharmaceutical Commerce

JUNE 16, 2025

24 Hours in the Hub Still Matters More June 16, 2025 By Chris Dowd, ConnectiveRx Commentary Article Pharmaceutical Commerce Pharmaceutical Commerce - June 2025 Volume 20 Issue 3 Doubling down on patient access and support fundamentals will win out over Washington’s next move. Articles in this issue Policy Whiplash?

Insurance Coverage and Processing

Pharmaceutical Commerce

JULY 29, 2025

Key Takeaways A formal trade agreement between the US and EU introduces a 15% tariff on most EU exports, including pharmaceuticals, potentially costing the pharma sector $13 billion–$19 billion. Experts recommend stockpiling medications and using forecasting tools to navigate tariff uncertainty and mitigate potential supply disruptions.

Insurance Coverage and Processing

Proxsys Rx

APRIL 1, 2025

billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers which could further strain the healthcare safety net and patient care services. Recent estimates indicate that hospitals and clinics collectively lose around $3.2 Additionally, up to $8.4

Specialty Pharmacies

PharmaTech

JULY 23, 2025

In this first segment of a multi-part interview, Jason Waite, international trade expert at Alston & Bird, outlines how recent United States tariff activity could significantly impact pharmaceutical manufacturers. Subscribe Now!

Dosage

Pharmaceutical Commerce

JULY 22, 2025

A new state-of-the-art facility in Virginia will produce active pharmaceutical ingredients (APIs) for weight management and metabolic treatments, leveraging AI, automation, and data analytics. AstraZeneca will be investing $50 billion in the United States by the year 2030. Subscribe Now!

Drug Pricing

Pharmacy Times

JUNE 12, 2025

5 The Most Significant Driver of Health Care Spend Isn’t Drugs—It Isn’t Even Close Pharmaceutical manufacturers are a frequent punching bag for politicians, mostly because they are easy targets, and they tend to have more visible out-of-pocket exposure. Author(s): Troy Trygstad, PharmD, PhD, MBA, Pharmacy Times Editor in Chief Yes.

Pharmacy Technician

PharmExec

AUGUST 4, 2025

Author(s): Christopher Cole Key Takeaways Bio/pharmaceutical manufacturers are strained by evolving trade policies and tariffs, affecting profits and operational strategies. Share your voice!

Communication

PharmaTech

JULY 17, 2025

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. Check out the full article here !

Compounding

Pharmacy Times

AUGUST 5, 2025

4 TAX INCENTIVES FOR PHARMA AND RESEARCH AND DEVELOPMENT The OBBB extends and amplifies existing tax breaks, including research and development (R&D) credits and incentives for onshoring manufacturing—measures favored by pharmaceutical manufacturers. What will be the consequences of Donald Trump’s “One Big Beautiful Bill”?

Pharmacy Technician

Pharmaceutical Commerce

JUNE 16, 2025

Jordon ; Pavel Dimitrov May 28th 2025 Article This serialization system represents a business imperative that yields significant competitive advantages. Jordon ; Pavel Dimitrov May 28th 2025 Article This serialization system represents a business imperative that yields significant competitive advantages.

Online Pharmacies

Pharmaceutical Commerce

JUNE 18, 2025

Drugs of all kinds are getting smarter, resulting in growth opportunities for all types of pharmaceuticals, blending the line between pharmaceutical drugs and medical devices,” wrote Stephen Robinson, sales engineer with Coesia North America in an article 2 for Pharma Commerce. Pharmaceutical Commerce. May 6, 2025.

Drug Pricing

Pharmaceutical Technology

JUNE 19, 2025

GlobalData is the parent company of Pharmaceutical Technology. Editor’s note: This article was updated shortly after publication to include comment from Eisai and Eli Lilly. Kisunla is forecast to hit $1.6bn in sales by 2031, while Leqembi will achieve sales of $3.8bn by the same year. Sign up for our daily news round-up!

Communication

PharmaVoice

AUGUST 4, 2025

4, 2025 Amy Baxter Staff Reporter post share post print email license stock via Getty Images Listen to the article 6 min This audio is auto-generated. Published Aug. Recommended Reading Will pharma finally score a policy win for 340B?

Hospitals

Pharmaceutical Commerce

JUNE 18, 2025

June 18th 2025 Article The June issue of Pharmaceutical Commerce highlights the importance of embracing agility—and adaptable strategies—to better navigate industry challenges. Click here to view our interactive June 2025 issue! Related Content The Art of Agility Mike Hennessy Jr.

Insurance Coverage and Processing

FDA Law Blog: Biosimilars

JANUARY 16, 2025

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.

Pharmaceutical Manufacturing

Drug Patent Watch

DECEMBER 17, 2024

The Rise of Flexible Manufacturing Systems (FMS) One of the most significant advancements in CDMO operations has been the adoption of Flexible Manufacturing Systems (FMS). These modular setups allow for customizable production lines, opening doors to unlimited opportunities in drug development[2].

Drug Development

pharmaphorum

AUGUST 6, 2025

Skip to main content Wednesday 6 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)

Diabetes

European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.

Pharmaceutical Manufacturing

Drug Patent Watch

JANUARY 22, 2024

A recent article published in Health Affairs, delves into the Federal Trade Commission’s (FTC) concerns regarding the inclusion of improper patents in the FDA’s Orange Book by pharmaceutical manufacturers.

Pharmaceutical Manufacturing

Pharma Mirror

JUNE 24, 2021

The registration file — such as the Marketing Authorisation (MA) or Product Licence (PL) — may be considered as the equivalent to the manufacturing process, and from which parameters. The post What is Registration Drift in pharmaceutical manufacturing, and how can I avoid it? appeared first on Pharma Mirror Magazine.

Pharmaceutical Manufacturing

European Pharmaceutical Review

JULY 4, 2023

Included in this Guide to Data Integrity: The significance of data integrity in pharmaceutical manufacturing Are you leveraging all the information from your quality control data? A secure, compliant and powerful data management system is critical for maintaining your data integrity compliance.

Pharmaceutical Manufacturing