Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 More FDC products flowing into pharma pipelines. The numbers tell the story. new FDC products per year.

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Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir.

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Viseven

AUGUST 15, 2024

In an era where medicine is rapidly becoming more personalized, why do pharmaceutical companies still struggle to effectively engage with the very individuals they aim to serve? For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

generic drugs at both small development companies and multinational pharmaceutical companies. This unique pedigree gives the company a foundational understanding of how to launch products at every stage of development. US-based operations also offer greater access to FDA inspectors which can help speed up approvals.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. She has worked with regulatory agencies and pharmaceutical companies for over 10 years. Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry Draft Guidance.

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The Checkup by Singlecare

JANUARY 18, 2024

The patent protection for Nexplanon typically prevents other pharmaceutical companies from creating a generic version until the patent expires. Most insurance companies offer health insurance plans that cover Nexplanon and other birth control methods. Drug and Food Administration (FDA). intrauterine device $907 per 1, 13.5

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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. The pilot scheme for this has been observed by the FDA and EU Commission.

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The People's Pharmacy

JUNE 12, 2023

The parties that benefit are the pharmaceutical companies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. The FDA does virtually no testing.

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Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Pharmaceutical Technology

NOVEMBER 25, 2022

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Cambrex, for example, has a track record of success in partnering with several pharmaceutical companies in the development and commercialisation of clinically suitable PDFs. Faster to market.

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The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Pharmaceutical companies typically only provide prescription drug samples to healthcare providers, who keep them in the office for patients to use.

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pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain.

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BuzzRx

OCTOBER 14, 2022

Commercially Unavailable Medications Some medications are not profitable enough for large pharmaceutical companies to make. Off-Label Medication Use Sometimes healthcare providers prescribe an FDA-approved medication to treat a condition for which it is not FDA-approved. This might require the dosage to be adjusted.

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The Checkup by Singlecare

MARCH 30, 2023

How to get albuterol sulfate HFA without insurance Albuterol sulfate (also known as salbutamol) is a prescription generic inhalation solution packaged in a metered dose inhaler. | How much does albuterol sulfate HFA cost without insurance? | A generic levalbuterol inhaler costs nearly twice as much as the generic version of albuterol sulfate.

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Roots Analysis

AUGUST 1, 2024

GLP-1 receptor agonist market have captured the attention of both large and small pharmaceutical companies, for more than a decade. Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA.

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ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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PharmaShots

FEBRUARY 27, 2023

The speakers shared their views on the topic: Dr. Jagadeesh Babu Rangisetty- “COVID has taught us so many things and the pharmaceutical company has gone through a lot of challenges and at the same time opportunities. According to me the main issue faced during the pandemic was the supply chain of pharmaceuticals.

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The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Ozempic, Wegovy, and Rybelsus are the only FDA-approved drugs that contain semaglutide.

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European Pharmaceutical Review

AUGUST 23, 2022

On- or in-dose authentication means that a security measure or anticounterfeit feature is integrated with the dosage form itself, offering product verification and traceability embedded into each medicine, rather than on the secondary package” WHO estimates that >50 percent of the drugs for sale on the internet are fake.

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European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Regulatory decisions come in.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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PharmaShots

JUNE 7, 2023

To further expedite the introduction of the biosimilar globally, EirGenix has been in talks with global pharmaceutical companies about licensing the marketing rights to EG1206A 5. Amgen also claims that the US FDA approval decision on the biosimilar candidate could come before its relevant patents expire.

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ISPE

NOVEMBER 2, 2022

Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. President, U.S. Business Unit and U.S. Country Head.

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PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics).

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pharmaphorum

AUGUST 16, 2021

These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages. I can’t imagine that pharmaceutical companies will return to the ways of the past. About the interviewee.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), They’re great for injuries, overuse, or soreness from workouts.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Source: GlobalData Pharmaceutical Intelligence Center.

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Pharmaceutical Technology

DECEMBER 9, 2022

Pharmaceutical Technology Excellence Rankings – The Verdict. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings.

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Pharmaceutical Technology

JULY 14, 2022

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Consequential FDA and EMA decisions.

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ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

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STAT

MARCH 19, 2025

Food and Drug Administration has warned Aspen Pharmacare, the largest pharmaceutical company in Africa, that it had failed to take sufficient steps to prevent microbial contamination at a key facility that makes eye drops and many other medicines that require sterile production. Continue to STAT+ to read the full story…

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Pharma Marketing Network

APRIL 3, 2025

Additionally, integrating offline and online experiencessuch as QR codes on packaging leading to mobile resourcesenhances the continuity of care. Navigating Compliance While personalization and interactivity are powerful, they must align with FDA regulations. FAQs What is patient marketing in pharma?

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pharmaphorum

MAY 26, 2022

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the authors.

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