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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.
UK-based pharmaceutical giant GSK has announced that the US Food and DrugAdministration (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.
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.
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.
The US Food and DrugAdministration (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.
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
Tell us about Ocugen’s lead programme, OCU400. In April 2024, Ocugen received US Food and DrugAdministration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.
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 DrugAdministration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5
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?
AGEPHA Pharma has received approval from the US Food and DrugAdministration (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.” The company expects to launch LODOCO for prescription use in the second half of 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.
Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. Final guidance is scheduled to be published on 11 October 2023. The US Food and DrugAdministration (FDA) first approved tirzepatide for type 2 diabetes in May 2022.
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.
The US Food and DrugAdministration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma.
The US Food and DrugAdministration (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.
PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and DrugAdministration (FDA).
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
According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. Additionally, these first results were also presented at the 2023 International Limb-Girdle Muscular Dystrophy Conference. At present, there are no curative treatments for LGMD2I/R9.
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?
In the US, botanical dietary supplements can be sold without US Food and DrugAdministration (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?
The US Food and DrugAdministration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The 244,000 square foot facility in Devens is BMS’ third commercial cell therapy facility in the US.
Harwell, the UK’s leading science and innovation campus in Oxfordshire will be the location of the Moderna Innovation and Technology Centre (MITC). Construction will begin in 2023. This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022.
This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. Under the terms of the deal, BMS will acquire all outstanding shares of Karuna Therapeutics common stock for $330.00
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.
“This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. FDA approves first treatment for geographic atrophy Avacincaptad Pegol Avacincaptad pegol (ACP) is a complement C5 protein inhibitor.
UK approval of Litfulo follows Europe and US The MHRA authorisation follows approval by the European Medicines Agency (EMA) in September and by the US Food and DrugAdministration (FDA) in July 2023.
Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. These innovations bestow visual inspection processes with unprecedented precision, identifying imperfections and anomalies that often elude human scrutiny.
The US Food and DrugAdministration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. US FDA granted approval of Abrysvo to Pfizer Inc.
SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and DrugAdministration (FDA) for geographic atrophy (GA), a leading cause of blindness. SYFOVRE is expected to be available by the beginning of March 2023. GA is an advanced form of age-related macular degeneration (AMD).
Of the 175 new drugs approved by the US Food and DrugAdministration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and DrugAdministration (FDA) between 2016 and 2019, most were biologics.
The clinical trial is estimated to be completed in March 2023. A two-dose version of the vaccine was approved by the US Food and DrugAdministration (FDA) in 2017. It causes severe hepatitis B infection that can lead to progressive liver disease. So positive data from the ongoing Phase III study is welcomed.
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.
Ocugen has received orphan drug designation from the US Food and DrugAdministration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. This condition leads to a gradual deterioration of vision in children.
difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.
Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. There have been many cases where people have tried to simply link existing drugs to radioisotopes or have attached new (recently made in scale) radioisotopes on old drugs. This is not an effective strategy.
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. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.
The company expects to present further results from the Phase I dose exploration stage in both cohort one and cohort two at the North American Cystic Fibrosis Conference in November 2023. 4DMT aims to start the Phase II dose expansion stage in H2 2023.The The company plans to provide an update on this program in H2 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. In November 2022, the Taiwan Food and DrugAdministration granted accelerated approval designation (AAD) to Nefecon.
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? What are the current trends in antibody therapeutics?
For IgA nephropathy (IgAN), key highlights include the US Food And DrugAdministration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
For IgA nephropathy (IgAN), key highlights include the US Food And DrugAdministration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
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.
This successful outcome for insulin icodec increases the likelihood of achieving Food and DrugAdministration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.
The US Food and DrugAdministration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.
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