European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialisation of exa-cel.

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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

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 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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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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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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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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Pharmaceutical Technology

JULY 14, 2022

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.

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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 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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European Pharmaceutical Review

APRIL 30, 2024

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.

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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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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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World of DTC Marketing

SEPTEMBER 22, 2020

Under no circumstances can ANY pharma company allow this administration to fastback a COVID vaccine for political purposes. To do so would derail our drug safety and lead to patients and HCP’s to question all prescription drug data. To do so would mean an end to ANY trust in prescription drugs and their safety.

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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 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 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

NOVEMBER 9, 2023

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.

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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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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

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

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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Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. This includes Apretude and the two oral drugs— Descovy and Truvada.

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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

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

OCTOBER 9, 2022

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.

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European Pharmaceutical Review

MARCH 7, 2024

Julien Dodet, CEO of Orano Med discusses the company’s approach to developing and manufacturing radioligand alpha therapies and predicts the key factors that could impact the field in the next five years. Orano Med is now building industrial facilities throughout the world for the commercialisation its drugs.

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World of DTC Marketing

SEPTEMBER 28, 2020

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

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European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. percent through 2027.

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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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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024. This site will be used for Adstiladrin production.

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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

SEPTEMBER 26, 2023

It covers the same indication approved by the EC for the reference medicine Tysabri ® * (natalizumab). This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Tysabri ® is a registered trademark of Biogen MA, Inc.

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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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World of DTC Marketing

AUGUST 22, 2020

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” the president wrote. To them manufacturing without full trials is dangerous. This is beyond irresponsible and clearly shows that he is unfit mentally to hold office.

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European Pharmaceutical Review

DECEMBER 13, 2022

The World Health Organization (WHO) linked this recent incident to an Indian manufacturer, saying that the cough syrups contained “unacceptable amounts of diethylene glycol and ethylene glycol”. This was also the first step on the road towards universal adoption of good manufacturing practice (GMP).

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European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. In parallel, European Medicines Agency (EMA) has issued an update on its guidance.

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