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

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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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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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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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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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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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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European Pharmaceutical Review

DECEMBER 30, 2024

It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000. 1 It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000.

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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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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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European Pharmaceutical Review

APRIL 26, 2024

Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine. Samsung Bioepis is responsible for development, registration, intellectual property (IP), manufacturing and supply. It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology.

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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

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings.

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European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The aim is to remove the regulatory burden of reassessment following certain changes and updates to a medical device by a manufacturer.

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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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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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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label.

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European Pharmaceutical Review

JULY 10, 2023

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. Analysis reports nitrosamine prevalence in small molecule drugs The post EMA revises guidance on nitrosamine impurities appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

SEPTEMBER 8, 2023

Tirzepatide The novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, is licensed for adults with insufficiently controlled type 2 diabetes when metformin cannot be tolerated, Helen Knight, Director of medicines evaluation at NICE explained.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Pharmaceutical Technology

APRIL 18, 2023

Eli Lilly and Company (Lilly) has unveiled plans to invest $1.6bn in its two new manufacturing facilities located within the LEAP Innovation Park in Boone County, Indiana, US. The investment at the LEAP site marks the company’s biggest manufacturing investment at a single location to date.

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pharmaphorum

JANUARY 30, 2023

The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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European Pharmaceutical Review

MARCH 1, 2024

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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European Pharmaceutical Review

NOVEMBER 15, 2022

The post GAMP 5 update: computerized system expectations for pharma manufacturers appeared first on European Pharmaceutical Review. Stephen has 20 plus years of IT Compliance experience in the regulated Life Sciences and currently leads the IT Governance & Software Assurance practices within CompliancePath an Ideagen company. .

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Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases.

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European Pharmaceutical Review

AUGUST 31, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended authorising an adapted COVID-19 Comirnaty vaccine targeting the Omicron XBB.1.5 The EMA’s human medicines committee evaluated all the available data on Pfizer Inc. subvariant. Omicron XBB.1.5

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PM360

AUGUST 26, 2024

Now, precision medicine needs an overhaul. During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers.

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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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European Pharmaceutical Review

OCTOBER 19, 2023

In this exclusive discussion with EPR , Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape, including the challenges of manufacturing these cancer treatments and why radiopharmaceutical therapeutics are so promising for this widespread disease.

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Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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European Pharmaceutical Review

JULY 11, 2023

A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted the importance of post-approval R&D in advancing oncology treatment options and delivering unprecedented progress over the past ten years. This therefore broadens the population of patients who may benefit.

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European Pharmaceutical Review

AUGUST 25, 2023

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. As the reference medicine, Tysabri is a highly effective anti-α4 integrin monoclonal antibody disease modifying treatment, according to Sanzoz. Approval of Tyruko has been granted to Sandoz Inc.

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pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.

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