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billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and DrugAdministration approval for the non-Hodgkin lymphoma drug by a Dec. The post BMS: Delayed new drug to avoid paying billions?
In April 2024, Ocugen received US Food and DrugAdministration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. What are the top three challenges associated with gene therapy manufacturing? How are new technologies speeding up impacting gene therapy manufacturing?
A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The post Switzerland and US sign drug inspection agreement appeared first on European Pharmaceutical Review.
Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. For the COVID-19 vaccine, the Food and DrugAdministration (FDA) set up rigorous standards for vaccine developers to meet.
It is the company ’s most advanced manufacturing facility to date. Additionally, in partnership with Columbus State Community College, Amgen declared that it hosting an 18-month manufacturing apprenticeship at the new facility. Amgen has opened a new biomanufacturing plant in Central Ohio, US.
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.
The US Food and DrugAdministration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said. “The
The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.
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.
Food and DrugAdministration (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. .
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.
A new three-year research programme led by researchers at Massachusetts Institute of Technology ( MIT ) is aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. The $82 million project is funded by the US Food and DrugAdministration (FDA) Center for Biologics Evaluation and Research.
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?
The US Food and DrugAdministration (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.
a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and DrugAdministration (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.
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.”
The Office of Pharmaceutical Quality (OPQ) in the US Food and DrugAdministration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drugmanufacturers and their products.
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.
The US Food and DrugAdministration (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.
The US FoodDrugAdministration (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.
What are the top three trends that you are seeing in the biopharma manufacturing space? This resulted in not only a mismatch in the required manufacturing scale but also a significant over capacity as well. Let’s talk about continuous biopharma manufacturing. I believe this is going to be an emerging trend in the market.
Research published in the journal Nature Chemistry , shows how researchers from Stanford University in the US uncovered a promising new method to synthetically manufacture the compound tigilanol tiglate, named EBC-46, which could offer targeted medicine for cancer and other diseases.
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?
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”.
Draft guidance published by the US Food and DrugAdministration (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.
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?
In the US, botanical dietary supplements can be sold without US Food and DrugAdministration (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?
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.
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?
The US Food and DrugAdministration (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.
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.
In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. A chief reason for the speedy turnaround was a decision the federal government made to expedite delivery of the vaccine — which has nothing to do with the scientific validity of the drug itself.
The US Food and DrugAdministration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drugmanufacturing facilities identified in pending marketing applications. The alternative tools will help the FDA to meet user fee goal dates and make timely application decisions.
IntelGenx Corp announced that the US Food and DrugAdministration (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.
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).
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.
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.
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.” One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al.
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
In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.
A study of the causes of warning letters issued by the US Food and DrugAdministration (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.
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.
As advancements in delivery systems, RNA modification technologies, and manufacturing processes address lingering challenges, the industry is gaining momentum toward broader commercialisation and clinical adoption. Innovation in base modification could be transformative for differing profiles of future RNA vaccines.
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