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

JANUARY 25, 2023

Earlier results from these ongoing trials were published in The New England Journal of Medicine in January 2021 and presented at the European Hematology Association Congress in June 2022. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialisation of exa-cel.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

Pharmaceutical Technology

MAY 23, 2023

In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration. The company will also provide knowledge transfer and other related services to support the programme’s transition.

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European Pharmaceutical Review

JANUARY 4, 2024

Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). The drug tocilizumab for example, has been used historically to treat CRS from immunotherapies. An overactive immune response [is] the hallmark of CRS,” Landgren added.

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Side effects Food and Drug Administration Patients Medicine 97

Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. This signifies the growth potential of marketed drugs in established marketplaces and the complexity of oncology treatment paradigms.

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Food and Drug Administration Marketing Patients Doctors 52

European Pharmaceutical Review

MARCH 6, 2023

Harwell, the UK’s leading science and innovation campus in Oxfordshire will be the location of the Moderna Innovation and Technology Centre (MITC). This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022.

Manufacturing 98

Manufacturing Food and Drug Administration Government Food 98

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). This could lead to significant research waste.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

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

AUGUST 10, 2022

It was approved by the US Food and Drug Administration in October 2021 as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA-associated vasculitis), in combination with standard therapy.

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Food and Drug Administration Pharmaceutical Food Medical 97

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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Food and Drug Administration Consulting Marketing Manufacturing 98

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.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Food Medicine 98

Pharmaceutical Technology

MAY 12, 2023

Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease. In December 2022, the company presented data from the first two patients treated in the Phase I/II RUBY (NCT04853576) trial.

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Food and Drug Administration Food Patients Safety 98

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

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FDA Food and Drug Administration Food Safety 115

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 95

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. It has also outlined the various issues impacting on the drug product.

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Food and Drug Administration Manufacturing Food FDA 52

Legacy MEDSearch

SEPTEMBER 16, 2022

the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Tasso+ device-based solutions with Class II clearance will be widely available to customers across the country in Q4 2022.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., 1 ranking in 2021.

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FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. We are committed to continuous improvement to optimize the clinical utility of the Swoop® system while driving commercial adoption across leading institutions globally. Hyperfine, Inc., Hyperfine, Inc.

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Food and Drug Administration FDA Recruitment Food 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. No serious adverse events were reported.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 105

Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Singapore has therefore become the second country to accept the NDA, following mainland China in November 2022.

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Food and Drug Administration Food Medicine Safety 52

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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Food and Drug Administration Manufacturing Side effects Doctors 105

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. ECG leads).

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Food and Drug Administration FDA Medical Food 105

European Pharmaceutical Review

APRIL 21, 2023

2022; 6: 949-57. In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs. Lancet Planetary Health.

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Pharma Food and Drug Administration Medicine Pharmaceutical 98

European Pharmaceutical Review

MAY 4, 2023

Martin Vogel, Janssen’s Therapeutic Area Lead Oncology for the Europe, Middle-East and Africa (EMEA) region shared with EPR what makes the BsMAb promising for treating this indication. Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? 2022; 10(1). 2022; 24(2): 89 – 97.

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Food and Drug Administration Safety Patients Medicine 98

Legacy MEDSearch

MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Food and Drug Administration FDA Recruitment Physicians 97

European Pharmaceutical Review

MARCH 2, 2023

This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023. Improvements were also seen in the drug development process itself. The transition to the new registration system has begun in earnest now.

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Food and Drug Administration Government Management Medicine 98

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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Food and Drug Administration Manufacturing Safety Transportation 97

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. For more information, please visit www.vivasuremedical.com.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

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Food and Drug Administration Recruitment Prospecting Food 52

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 3 The CARs recognise and bind to proteins on the surface of cancer cells, effectively killing them.

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Engineering Food and Drug Administration Patients Safety 98

Pharmaceutical Technology

JUNE 8, 2023

While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the drug’s effects on quality-of-life and spirometry-measured outcomes in a limited set of patients. 4DMT presented the results on 8 June at 5pm CET.

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Patients Food and Drug Administration Food Safety 98

pharmaphorum

JANUARY 30, 2023

One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages. 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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Food and Drug Administration Medicine Manufacturing Pharmaceutical 104

Pharmaceutical Technology

NOVEMBER 1, 2022

In May 2022, the US Food and Drug Administration (FDA) granted orphan drug designation for selinexor in MF indication. It leads to widespread bone marrow scarring, causing severe anaemia. The therapy is commercialised in the US as Xpovio.

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Food and Drug Administration FDA Medicine Food 52

Pharmaceutical Technology

JUNE 5, 2023

Led by the investment company Temasek, the round will also be used to improve the company’s commercial readiness as its lead radiopharmaceutical candidate ITM-11 is being studied in Phase III trials in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Other investors included BlackRock, the Qatar Investment Authority, and Nextech.

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Food and Drug Administration Food Patients Manufacturing 59

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. 1 Between 2022 and 2023, 47% of Phase III oncology trials involved combination therapies, a number that continues to grow over time (see Figure 1). 3 (2022): e222265. References: 1. Benjamin, Alexander Xu, Mark P.

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Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

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Manufacturing Food and Drug Administration Patients Pharma 104

Medico Reach

OCTOBER 17, 2022

from 2022 to 2030. However, this can lead to several issues, such as: Implantation resistance due to reactionary metabolism Allergic reactions to the nickel component found in stainless steel composites Widespread bone destruction due to immunological responses to cobalt particles. The US-based Enovis is leading this new development.

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