Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (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.

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Food and Drug Administration FDA Food Manufacturing 98

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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World of DTC Marketing

APRIL 15, 2021

In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. But it’s a bet that seems to have paid off.

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Food and Drug Administration Government Safety Manufacturing 203

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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Food and Drug Administration Side effects Pharmaceutical Leads 115

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

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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Food and Drug Administration Manufacturing Management Safety 98

Legacy MEDSearch

DECEMBER 21, 2022

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?

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Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (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.

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Food and Drug Administration FDA Food Marketing 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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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

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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Food and Drug Administration Manufacturing Pharma Patients 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.

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Food and Drug Administration Manufacturing Food Medicine 98

European Pharmaceutical Review

JANUARY 23, 2023

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

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Pharmaceutical Technology

NOVEMBER 7, 2022

Leveraging its cell expansion and activation technology as well as cell manufacturing capabilities, the company can extend NK cells while substantially boosting cytotoxicity across peripheral blood-derived products. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease.

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Food and Drug Administration FDA Manufacturing Food 105

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

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European Pharmaceutical Review

SEPTEMBER 8, 2023

Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. Upon publication, tirzepatide will be made available in the NHS within 90 days, although this is dependent on manufacturing supply. Final guidance is scheduled to be published on 11 October 2023.

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Food and Drug Administration Medicine Food Manufacturing 105

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. The history of PIE.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.

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European Pharmaceutical Review

JANUARY 25, 2023

Exa-cel has been granted Orphan Drug Designation from the European Commission (EC), as well as Priority Medicines (PRIME) designation for both SCD and TDT from the EMA. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialisation of exa-cel.

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Medicine Food and Drug Administration FDA Pharmaceutical 111

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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Food and Drug Administration Manufacturing FDA Food 96

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

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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Food and Drug Administration Manufacturing Side effects Doctors 105

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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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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Food and Drug Administration Manufacturing Engineering Food 97

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

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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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.

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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

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al.

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European Pharmaceutical Review

OCTOBER 21, 2022

It will also evaluate ENGERIX-B, a GSK-manufactured three-dose hepatitis B vaccine series. A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. It causes severe hepatitis B infection that can lead to progressive liver disease.

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Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). This leads to hyperammonaemia, which causes symptoms such as vomiting, mental confusion, and lethargy. Current treatments focus on detoxifying ammonia from the blood.

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Food and Drug Administration Manufacturing Pharmaceutical Marketing 98

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. About NeuroLogica. NeuroLogica Corp., NeuroLogica Corp.,

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European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024.

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

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European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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