European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.

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European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Approximately 40 million people in the US experience Type I allergic reactions due to food, venom or insect stings, 4 and the numbers are similar in Europe. What are the main advantages of EURneffy over similar treatments?

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European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

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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. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

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

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European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

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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.

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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.

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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.

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World of DTC Marketing

NOVEMBER 1, 2020

Over the past six months , pharmaceutical companies have made various predictions about their Covid-19 vaccine timelines that have turned out not to be true. In one recent example, Pfizer?has has said for weeks?it?

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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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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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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European Pharmaceutical Review

NOVEMBER 21, 2022

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). The post First-in-human gene therapy trial for major cardiac syndrome appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients.

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European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs?

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European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

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Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.

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European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

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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? 3 Is two too few?

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Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. Indicated for administration rectally, Rebyota is a single-dose 150ml microbiota suspension. .

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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

MAY 22, 2024

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

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European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. The safety and efficacy profile was consistent with the IV formulation.

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Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Pharmaceutical Technology

JUNE 29, 2022

Safety observations were in line with Yescarta’s known safety profile. In April this year, the US Food and Drug Administration (FDA) granted approval for Yescarta for adult patients with large B-cell lymphoma. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. The USP also introduced a general monograph for the good distribution practices (GDP) for bulk pharmaceutical excipients (<1197>).

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European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto. The PSMAfore study.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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