Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

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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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Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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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

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Topic sponsors are not involved in the creation of editorial content.

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World of DTC Marketing

FEBRUARY 7, 2021

Drug Discovery and Manufacturing: It helps in the initial screening of drug compounds to the predicted success rate based on biological factors. Precision medicine or next-generation sequencing helps in the faster discovery of drugs and tailored medication for individual patients. . Measuring RNA, DNA quickly.

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European Pharmaceutical Review

SEPTEMBER 25, 2023

The measured relaxation rate constants resulting from fast chemical exchange between water and exposed NH and OH protons on proteins can be selective to biologics. Failure to do so has resulted in several warning letters to manufactures. Fortunately, these capabilities are in development with several manufacturers.

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Pharmaceutical Technology

MAY 1, 2023

The grant will help in expediting pre-clinical and manufacturing activities of the product. In March this year, the US Food and Drug Administration (FDA) accepted Ossium Health’s Investigational New Drug (IND) application for OSSM-001 to treat refractory perianal fistulas in Crohn’s disease patients.

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Pharmaceutical Technology

MAY 5, 2023

Siegfried will leverage DiNAMIQS’ capabilities to commercial scale by constructing a facility that complies with good manufacturing practice standards. The move represents Siegfried’s strategy to expand its presence in biologics, and provides important growth opportunities in the mid to long term.

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Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. Topic sponsors are not involved in the creation of editorial content. The therapy is currently under development for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM).

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Pharmaceutical Technology

JANUARY 12, 2023

The collaboration will use the vector biology, manufacturing capabilities and the drug development experience of Solid Biosciences and Phlox Therapeutics’ knowledge in genetic cardiomyopathies and RNA therapies. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper.

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Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

MAY 3, 2023

An anti-CD19 and CD20 bi-specific (CAR-T) therapy, C-CAR039 received regenerative medicine advanced therapy and fast-track designations from the US Food and Drug Administration to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 1-adapted vaccine.

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European Pharmaceutical Review

AUGUST 17, 2022

million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). Steve Brooks, Manufacturing Lead at the AMR Industry Alliance (Advisor to the Alliance): AMR is multifaceted; there are many potential causes, including environmental ones.

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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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pharmaphorum

OCTOBER 30, 2019

Overview Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies). However, there are limitations in the breadth and utility of these tools.

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PM360

SEPTEMBER 21, 2023

Our solutions enable pharma manufacturers to engage with providers and patients so they can start and stay on the right medication and improve their health outcomes. 4 Specialty drugs now account for 55% of category spending, 5 primarily driven by costs and growth in immunology and oncology therapies (Figure 1).

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Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. Across the world, to varying degrees, the regulations were written in an era of small molecules and biologics.

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PM360

DECEMBER 14, 2023

Chief among them is the now proven mRNA vaccine technology, which can be used to develop safe and effective vaccines with remarkable speed that can be rapidly manufactured at scale.” Additionally, MedCentral offers diversity topics and points of view to ensure clinicians find the support they need.

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European Pharmaceutical Review

OCTOBER 2, 2023

Silvia Forroova, Director of partnerships & sustainability, Informa Markets, commented: “We are very excited to be back in Barcelona, one of Europe’s premier biotech and pharma manufacturing hubs. At the heart of pharma, we provide the vital connections that will underpin growth in pharma manufacturing in the next few years.

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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. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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Pharmaceutical Technology

MARCH 10, 2023

Cell One Partners offers virtual company creation and management to its clients for complete aspects of the development and commercialisation of drugs. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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European Pharmaceutical Review

DECEMBER 21, 2022

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines.

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European Pharmaceutical Review

FEBRUARY 23, 2023

Despite this overlap, this article addresses the main challenges for industry and firms, and those for pharmaceutical microbiologists, separately, focusing on some of the difficult and often overlooked hurdles relating to quality assurance (QA) and quality control (QC) of licensed and marketed pharmaceutical drug products.

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Pharmaceutical Technology

FEBRUARY 24, 2023

It will combine the extensive capabilities of AbbVie with the new adeno-associated virus (AAV) engineering platform and the manufacturing capability of Capsida for identifying and advancing three programmes. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

FEBRUARY 8, 2023

This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development. In 2022, 54% of FDA new drug approvals were for rare diseases , a significant increase in proportion of approvals in the recent years. GlobalData is the parent company of Pharmaceutical Technology.

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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. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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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). Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

MARCH 6, 2023

Under the licence deal, Novartis will gain exclusive global rights for the research, development, manufacturing, and commercialisation of the candidate for all potential indications. The company discovered the new investigational small molecule candidate at a drug development base in Tokyo, the Teijin Institute for Biomedical Research.

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Cadensee

OCTOBER 19, 2021

We are aiming for a therapeutic effect that is no less of a drug. It's about the right kind of publication strategy, the right kind of health economics models, the ability to manufacture at scale and so forth. By the way, with a very attractive safety profile so far. We're using AI; we're using cloud.

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Pharmaceutical Technology

FEBRUARY 24, 2023

antibody-drug conjugate (ADC), CMG901. Under the licence deal, AstraZeneca will handle the research and activities related to the development, manufacturing, and commercialisation of CMG901 globally. Topic sponsors are not involved in the creation of editorial content. expressing cancers.

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Pharmaceutical Technology

MARCH 9, 2023

Under the partnership, the Centre for Drug Development of Cancer Research UK will appoint the chief clinical and scientific investigators. It will also lead the design, preparation, funding, and delivery of Phase I/II studies for both candidates, while UCB will continue their manufacturing.

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Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. The texture and quality of any topical formulation is critical.

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