Search Results for “EU” – Page 31 – media

US WorldMeds’ Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. This week, the U.S. FDA approved US WorldMeds’ (USWM) Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior multiagent, multimodality treatment, USWM said in a press release. Between 700 and 800 cases of neuroblastoma are diagnosed in the U.S. each year, according to the American Cancer Society. Ninety percent of diagnoses occur before a patient is 5 years old and more than 50% of neuroblastoma cases are classified as high-risk. Approximately half of children with high-risk neuroblastoma don’t live more than five years past their diagnosis, USWM added. Avoiding relapse is ...
- Source: drugdu
- 89
- December 16, 2023
【EXPERT Q&A】What is a pharmaceutical intermediate?

Drugdu.com expert’s response: A pharmaceutical intermediate is a substance that is produced during the synthesis of an active pharmaceutical ingredient (API) and is used in the further production of the API. These intermediates are crucial compounds in the drug manufacturing process, acting as pivotal building blocks that are transformed through various chemical reactions to form the final active ingredient. Pharmaceutical intermediates can vary widely in their complexity and are often produced in controlled conditions to ensure purity and quality. These intermediates are integral to the pharmaceutical industry, allowing for the efficient and cost-effective production of APIs. They play a significant role in the development of new drugs and formulations, providing flexibility and innovation in drug synthesis and design. The quality and control of pharmaceutical intermediates are vital, as they directly affect the efficacy, safety, and stability of the final pharmaceutical products. Manufacturers of pharmaceutical intermediates must adhere to strict regulatory ...
- Source: drugdu
- 260
- December 15, 2023
intermediate
After leak of neurotoxin, Sanofi plant in France is under scrutiny again

A Sanofi manufacturing facility in France, which was temporarily closed five years ago for emitting dangerous emissions, is under the microscope again after a recent leak caused the release of the same neurotoxin, bromopropane. The plant, which produces epilepsy drug Depakine (sodium valproate), released 75 times the allowable amount of bromopropane in mid-November, according to a report in the French news outlet Le Monde. The facility, located in Mourenx, stopped production “immediately” after noting “inconsistent measurements” of bromopropane emissions, according to a Sanofi spokesperson. “We quickly identified that this isolated and very brief event was linked to the degradation of the treatment unit’s activated carbons following the bad weather and heavy rains that had affected the region in the preceding days,” Sanofi said. “The coals were replaced and bromopropane emissions returned to normal, enabling production to resume after approval from the authorities.” Bromopropane—which is used in the production of Depakine—is ...
- Source: drugdu
- 104
- December 14, 2023
Study reveals motor neuron region is affected in ALS

The neurological condition currently affects one in 300 people in the UK King’s College London (KCL) researchers have revealed a mechanism behind dysregulated neuronal activity, a key pathology of amyotrophic lateral sclerosis (ALS). The new study, published in Cell Reports, identifies the axon initial segment (AIS) as the region that drives abnormal regulation of neuronal activity in ALS. Affecting one in 300 people in the UK, ALS, or motor neurone disease, is a neurological disorder that progressively destroys neurons in the brain and spinal cord. Researchers found that the molecular, structural and functional changes in the AIS, the region where electrical signals in neurons initiate, cause abnormal neuronal excitability. In the study, researchers examined two of the most common genetic causes of AIS mutations in the genes, TDP-43 and C9ORF72. In ALS, the electrical signalling in motor neurons initially increases during the early stages of the condition and progressively becomes ...
- Source: drugdu
- 97
- December 9, 2023
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
- Source: drugdu
- 99
- December 6, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 99
- December 4, 2023
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

By Tristan Manalac Pictured: Sign outside the FDA’s office in Maryland The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India. The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination. In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with ...
- Source: drugdu
- 115
- December 2, 2023
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug

Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
- Source: drugdu
- 103
- December 1, 2023
【EXPERT Q&A】What are the processes involved in exporting pharmaceuticals to Japan?

Drugdu.com expert’s response: Exporting pharmaceuticals to Japan involves a complex process with multiple steps, due to the stringent regulatory system of the Japanese pharmaceutical market. Here are the key steps summarized by Dide Medical Trade Network: 1.Understanding Japanese Pharmaceutical Market Regulations Before starting the export process, it is crucial to have an in-depth understanding of Japan’s pharmaceutical regulatory laws. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main regulatory bodies responsible for the approval and supervision of pharmaceuticals. 2.Product Registration and Approval All pharmaceuticals intended for sale in the Japanese market must be registered and approved by the MHLW. This usually involves submitting detailed information about the pharmaceutical, such as clinical trial data, evidence of safety and efficacy, etc. 3.Japanese GMP Certification Japan has strict quality control standards for pharmaceutical production, and pharmaceuticals exported to Japan must be produced in ...
- Source: drugdu
- 270
- December 1, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 178
- November 26, 2023

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