European Pharmaceutical Review

JANUARY 29, 2024

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. In contrast, NDSRIs (N-Nitrosamine drug substance-related impurities) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

MAY 7, 2024

A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6 Injectable drugs are adopted widely as treatments for chronic infections such as HIV/AIDS and tuberculosis (TB). This has resulted in more access to injectable drugs. The market is anticipated to value $1139.4

Food and Drug Administration 94

Food and Drug Administration Marketing Government Food 94

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

Food and Drug Administration 97

Food and Drug Administration Patients Food Safety 97

PM360

APRIL 18, 2023

ISPOR—The Professional Society for Health Economics and Outcomes Research announced its ISPOR Real-World Evidence Summit 2023 scheduled for May 7 in Boston, MA, USA. The Summit is collocated with and being held immediately prior to the Society’s annual international conference, ISPOR 2023.

Food and Drug Administration 96

Food and Drug Administration Healthcare Healthcare Food 96

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Food and Drug Administration 126

Food and Drug Administration Medicine FDA Food 126

European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

Food and Drug Administration 105

Food and Drug Administration Manufacturing Pharmaceutical FDA 105

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. You can also subscribe here to receive email notifications when a new issue is available.

Food and Drug Administration 98

Food and Drug Administration Food Pharma Pharmaceutical 98

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

European Pharmaceutical Review

NOVEMBER 6, 2023

The findings presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, revealed that the treatment continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-month dosing compared to sham treatment over two years in geographic atrophy secondary to age-related macular degeneration (AMD).

Food and Drug Administration 101

Food and Drug Administration Safety Food Patients 101

European Pharmaceutical Review

MARCH 27, 2024

percent from 2023 to 2032, according to the research. For example, in 2023, Lonza Group launched several new solutions for endotoxin and pyrogen testing, the report highlighted. During a market recession, companies put less investment in R&D and consequently, this potentially slows the production of drugs, the authors shared.

Safety 94

Safety Marketing Food and Drug Administration Pharmaceutical 94

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment FDA 98

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

JUNE 27, 2024

Looking back briefly to 2023, within the cell and gene therapy space, the US Food and Drug Administration (FDA) approved marketing authorisations for seven of these treatments. References [link] [link] The post Drug approval roundup – May/June 2024 appeared first on European Pharmaceutical Review.

Food and Drug Administration 64

Food and Drug Administration Food Patients Marketing 64

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). It was co-created by Shionogi and Hokkaido University.

Food and Drug Administration 59

Food and Drug Administration Food FDA Patients 59

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. This document is revised from a version published in October 2023.

FDA 98

FDA Food and Drug Administration Safety Manufacturing 98

Pharmaceutical Technology

MAY 18, 2023

HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer.

Food and Drug Administration 59

Food and Drug Administration Food Patients Medical 59

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. On 2 May 2023, the FDA published draft guidance which included recommendations for delivering decentralised clinical trials.

Food and Drug Administration 104

Food and Drug Administration FDA Pharmaceutical manufacturing Manufacturing 104

Pharmaceutical Technology

SEPTEMBER 21, 2023

On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. The year 2023 also brought much advancement in the Alzheimer’s space for the pharmaceutical industry. Since then, EPR has covered developments for several of the therapies highlighted in the report.

Manufacturing 98

Manufacturing Food and Drug Administration Medicine Pharmaceutical manufacturing 98

European Pharmaceutical Review

NOVEMBER 16, 2022

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. Other drugs in Opiant’s development pipeline include OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO).

Food and Drug Administration 98

Food and Drug Administration Pharma Pharmaceutical Food 98

Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

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. EU Clinical Trial Information System From February 2023 all new clinical trials applications must be submitted via the new portal.

Food and Drug Administration 98

Food and Drug Administration Government Management Medicine 98

Pharmaceutical Technology

MAY 5, 2023

Regeneron Pharmaceuticals has reported a 7% rise in total revenue to $3.16bn in the first quarter (Q1) of 2023 compared to $2.96bn in Q1 2022. In Q2 2023, the US Food and Drug Administration approved Eylea, Kevzara (sarilumab), and Evkeeza (evinacumab).

Food and Drug Administration 52

Food and Drug Administration Sales Food Pharmaceutical 52

Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. We look forward to our upcoming meeting with the FDA on 1 May 2023 to discuss our planned Phase III clinical programme for XORLO.”

Food and Drug Administration 52

Food and Drug Administration FDA Pharmacology Food 52

European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. The biologic is approved for intravenous (IV) and subcutaneous (SC) administration.

Food and Drug Administration 104

Food and Drug Administration FDA Physicians Food 104

Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration FDA Food Pharmaceutical 59

European Pharmaceutical Review

JULY 21, 2023

The US Food and Drug Administration (FDA) published its discussion paper on AI in drug development in May 2023, and now European regulators following a similar route to help chart a new course for this emerging technology.

Food and Drug Administration 98

Food and Drug Administration Medicine Ethics Consulting 98

European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. These agreements have amassed a total deal value of $21 billion.

Food and Drug Administration 104

Food and Drug Administration Medicine Food Pharmaceutical 104

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

Food and Drug Administration 98

Food and Drug Administration Transportation FDA Medical 98

European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

Manufacturing 105

Manufacturing Food and Drug Administration Food Networking 105

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Distribution Food 105

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.

Food and Drug Administration 115

Food and Drug Administration Side effects Pharmaceutical Leads 115

Pharmaceutical Technology

MAY 25, 2023

The tablet form of metronidazole has been the only approved oral form of the drug available on the US market. The US Food and Drug Administration has set 23 September 2023 as the prescription drug user fee action date for ATI-1501.

Food and Drug Administration 105

Food and Drug Administration Prescription Food Medicine 105

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. This opinion is intended for use of the drug as a first-in-class treatment for adults with moderately to severely active UC.

Food and Drug Administration 52

Food and Drug Administration Manufacturing FDA Medicine 52

Pharmaceutical Technology

APRIL 28, 2023

Ocugen has received orphan drug designation from the US Food and Drug Administration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. Ocugen intends to file an investigational new drug application in the second quarter of 2023, with the aim of commencing a Phase I/II clinical study.

Food and Drug Administration 52

Food and Drug Administration Transportation FDA Food 52