European Pharmaceutical Review

APRIL 27, 2023

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.

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Legacy MEDSearch

OCTOBER 2, 2023

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

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European Pharmaceutical Review

MARCH 31, 2023

The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). The pharma companies who will manufacture the generic versions are Viatris, Aurobindo and Cipla.

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Medicine Manufacturing Food and Drug Administration Food 105

European Pharmaceutical Review

MARCH 27, 2025

According to the findings, nearly 90 percent of US biotechs rely on imported components for at least half of their products approved by the US Food and Drug Administration. Proposed tariffs on the EU would force half of companies to find new research and manufacturing partners.

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Medicine Food and Drug Administration Manufacturing Food 52

European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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Food and Drug Administration Manufacturing Pharmaceutical FDA 105

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper also highlighted that AI/ML can enhance manufacturing supply chain. Comment on the discussion paper here.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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Food and Drug Administration FDA Manufacturing Product sample 105

European Pharmaceutical Review

MARCH 6, 2023

Darius Hughes, UK General Manager at Moderna commented on the research, development and manufacturing facility: “We are delighted to reach this important milestone – we look forward to joining the Harwell Campus health tech cluster and contributing to the UK’s science and innovation community through investments in R&D.”

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European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions.

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Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

NOVEMBER 19, 2024

.” Ratio is honoured and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic” Novartis will be responsible for all remaining development, manufacturing, and commercialisation. This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals.

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Food and Drug Administration Manufacturing Food Safety 52

Infuse Medical

JULY 4, 2024

Or else looking to manufacture medical equipment in the United States? Do you know the FDA is the Food and Drug Administration? Brief Introduction to Key FDA Regulatory Requirements The Food and Drug Administration plays an important role in ensuring the safety of medical devices in the United States.

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Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously.

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Food and Drug Administration FDA Food Manufacturing 98

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Food and Drug Administration Manufacturing Management Product Knowledge 98

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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FDA Food and Drug Administration Patients Biopharma 207

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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Food and Drug Administration FDA Safety Manufacturing 98

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. The post Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions appeared first on European Pharmaceutical Review.

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Medical Manufacturing Food and Drug Administration Safety 104

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured.

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Food and Drug Administration Medicine Food Government 119

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

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Manufacturing FDA Food and Drug Administration Medical 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 97

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? What are the trends affecting drug development today?

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Food and Drug Administration Manufacturing Pharma Patients 98

Pharmaceutical Technology

JUNE 7, 2024

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

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Food and Drug Administration FDA Manufacturing Food 59

European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. The alternative tools will help the FDA to meet user fee goal dates and make timely application decisions.

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FDA Food and Drug Administration Manufacturing Food 105

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. This route of administration makes it a potential alternative, especially for migraine patients who suffer from migraine-related nausea.

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Food and Drug Administration FDA Food Marketing 98

Pharmaceutical Technology

APRIL 3, 2023

BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe.

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European Pharmaceutical Review

OCTOBER 3, 2024

Ferring Pharmaceuticals has opened a new European manufacturing site focused on supporting production for one of its gene therapies to treat non-muscle invasive bladder cancer (NMIBC). The global manufacturing hub in Kuopio, Finland will bolster supply of the drug substance of its gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg).

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Manufacturing Food and Drug Administration Food Pharmaceutical 59

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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Food and Drug Administration Manufacturing Food Medicine 98

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.

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Food and Drug Administration Food FDA Safety 40

European Pharmaceutical Review

SEPTEMBER 28, 2022

The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets. Sartans or angiotensin II receptor blockers (ARBs) are drugs indicated for the treatment of cardiovascular diseases. mm × 150 mm) with a binary gradient with water as mobile phase A and 0.1

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Food and Drug Administration Manufacturing Pharmaceutical Food 105

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

European Pharmaceutical Review

MARCH 27, 2024

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

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European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings.

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Food and Drug Administration FDA Medicine Government 111

European Pharmaceutical Review

NOVEMBER 21, 2024

The LAL reagents included in the cartridges are licensed by the US Food and Drug Administration (FDA). With over 22 years of experience, she has worked as a QC microbiologist in cell therapy and non-sterile pharmaceutical manufacturing, specialising in environmental monitoring and method validation.

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Food and Drug Administration Manufacturing FDA Pharmaceutical manufacturing 52

PM360

AUGUST 29, 2022

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute. There are no shortcuts in drug development, and nor should there be.

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Marketing Food and Drug Administration Pharma Manufacturing 105

Pharmaceutical Technology

JUNE 23, 2022

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.

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Pharmaceutical Technology

SEPTEMBER 13, 2023

The US Food and Drug Administration has sent letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.

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Food and Drug Administration Food Manufacturing FDA 52