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. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

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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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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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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). CMT1A is a progressive neuromuscular autosomal-dominant disease that leads to life-long loss of muscle function, as well as disability.

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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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Pharmaceutical Technology

JUNE 6, 2023

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Alkeus Pharmaceuticals intends to submit a new drug application for gildeuretinol in 2024.

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European Pharmaceutical Review

NOVEMBER 4, 2022

The US-based researchers modelled personalised treatments for each virtual patient, assessing US Food and Drug Administration-approved aducanumab and donanemab, a therapy currently being evaluated and other potential AD therapies. These are identical to doses used in human trials for FDA approval.

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Pharmaceutical Technology

MARCH 15, 2023

AcelRx Pharmaceuticals has announced the sale of its drug DSUVIA (sufentanil sublingual tablet) to Alora Pharmaceuticals. AcelRx will lead the relationship for ensuring the expected expansion of sales to the DoD, in return for the royalty on net sales.

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Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

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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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European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. 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. What’s the latest and what’s next?

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

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European Pharmaceutical Review

MAY 12, 2023

Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma. The post $1.7b

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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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European Pharmaceutical Review

OCTOBER 19, 2023

The Investigational New Drug (IND) application for Intellia Therapeutics’ in vivo CRISPR-based candidate NTLA-2001, has been cleared as a gene editing therapy for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) in the US. This supports NTLA-2001’s potential as a single-administration therapeutic.

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European Pharmaceutical Review

AUGUST 23, 2022

PTSD is a potentially chronic condition that disrupts lives and can lead to or exacerbate existing health issues such as depression, anxiety, eating disorders, and suicidal thoughts. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus.

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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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Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

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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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PM360

OCTOBER 25, 2023

Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. Similarly, major pharmaceutical companies are not likely to up their engagement in cannabis drug development. How should they respond?

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European Pharmaceutical Review

JANUARY 5, 2024

Utilising an add-on therapy for treatment-resistant schizophrenia (TRS) Newron Pharmaceuticals SPA has reported significant final, one-year results from its clinical trial 014/015, evaluating evenamide as an add-on therapy to antipsychotics in treatment-resistant schizophrenia (TRS).

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European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The post First pill for desmoid tumours approved appeared first on European Pharmaceutical Review.

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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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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

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European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 Ultimately, this leads to heart failure and can be fatal for male patients.

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European Pharmaceutical Review

OCTOBER 2, 2023

Due to observed clinical success, Acurx Pharmaceuticals, Inc. has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). appeared first on European Pharmaceutical Review. Developing a front-line C.

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Pharmaceutical Technology

NOVEMBER 7, 2022

A lead product candidate of the company, SNK01 is presently being analysed as a single agent and along with other agents, including checkpoint inhibitors and cell engagers, in trials to treat advanced refractory solid tumours. . “We Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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European Pharmaceutical Review

JANUARY 25, 2023

The MAA from Vertex Pharmaceuticals and CRISPR Therapeutics is supported by two global Phase III studies. 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.

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European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. Therefore, it is essential that we broaden the scope of medical trials and research,” commented Tinamarie Duff, DAWN Global People & Business Resource Group Lead.

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European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. per share in cash.

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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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Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. Eisai is leading development of LEQEMBI and regulatory submissions globally.

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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?

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