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FDA approves X4 Pharmaceuticals’ WHIM syndrome drug

The US Food and Drug Administration (FDA) has approved X4 Pharmaceuticals‘ XOLREMDI (mavorixafor) capsules for patients aged 12 and above with warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) syndrome. This marks a significant advancement in the treatment of WHIM syndrome, a rare combined primary immunodeficiency and chronic neutropenic disorder. XOLREMDI is a selective CXC chemokine receptor 4 (CXCR4) antagonist. It is the first drug specifically indicated to treat patients with WHIM syndrome. X4 Pharmaceuticals president and CEO Paula Ragan stated: “The approval of XOLREMDI is a transformational milestone both for X4 and, more importantly, for the WHIM syndrome community. “We are incredibly grateful to the people living with WHIM syndrome, their families, and the investigators who took part in our clinical programme, to US regulators for their continued focus on rare-disease treatment development, and to our dedicated employees for making this targeted breakthrough therapy a reality.” ...
- Source: https://www.pharmaceutical-technology.com/news/fda-x4-syndrome-drug/?cf-view
- 103
- May 3, 2024
Lupin receives EIR from USFDA for its Aurangabad manufacturing facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”
- Source: https://www.lupin.com/lupin-receives-eir-from-us-fda-for-its-aurangabad-manufacturing-facility/
- 94
- May 3, 2024
New Drug Application of Zydus’ Desidustat tablets by China Medical System Holdings accepted in China

Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020. Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability. Discovered and developed by Zydus, Desidustat is being marketed by the group ...
- Source: https://www.biospace.com/article/releases/china-medical-system-new-drug-application-of-desidustat-tablets-accepted-in-china/
- 128
- May 3, 2024
Pioneer Institute study finds IRA discourages non-opioid drug innovation

Astudy from a US-based public policy research firm has highlighted that the US Inflation Reduction Act (IRA) is likely to stifle research efforts into non-opioid pain medications. The ongoing opioid crisis in the US demands alternatives to addictive pain medications. Several pharma companies have been accused of fuelling the opioid crisis by downplaying the addiction risks of their prescription pain drugs, contributing to the out-of-control opioid addiction problem in many American cities. The majority of heroin and fentanyl addictions stem from initial use of prescription drugs. According to a report on GlobalData’s Pharma Intelligence Center, there were 1,038,938 diagnosed cases of opioid use disorder in the US in 2022. This number is expected to increase to 1,062,610 in 2027. Introduced in 2022, the IRA allows Medicare to negotiate prices and rebates for certain drugs from drug makers in a pursuit to curb inflation. Critics have said the IRA may discourage ...
- Source: drugdu
- 127
- May 3, 2024
Ono Pharmaceutical acquires cancer-focused biopharma Deciphera for $2.4bn

Deciphera Pharmaceuticals is set to be acquired in a $2.4bn buyout, as the biopharma announced that it has commenced a definitive merger agreement with Ono Pharmaceutical. Under the terms of the offered transaction, Ono will make a cash purchase of all outstanding shares of Deciphera’s common stock at $25.60 per share and subsequently merge Deciphera with a wholly-owned subsidiary of Ono upon the deal’s completion. The deal has been unanimously approved by both companies’ boards of directors and is expected to close in Q3 2024. Following the announcement of acquisition, Deciphera’s stock has jumped 71.9%. Waltham, Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space. Upon the successful completion of the acquisition, Ono will gain access to Deciphera’s ...
- Source: drugdu
- 107
- May 3, 2024
New study reveals global risk distribution of visceral leishmaniasis

Announcing a new article publication for Zoonoses journal. Visceral leishmaniasis (VL) is a vector-borne disease posing increasing public health concerns. Although efforts to eliminate VL are underway, its global risk distribution remains unclear, because of changes in transmission risk. Worldwide province-level data on VL incidence were obtained from multiple sources. The authors of this article analyzed the global evolution features of VL and estimated its ecological niches with boosted regression tree models. A risk map was generated to analyze regions with high VL risk. A total of 558 articles and 2,694 records from 310 provinces were included. The model indicated that precipitation in the warmest quarter and poor socio-demographic index were the most significant risk factors affecting VL distribution. The risk map indicated that Brazil, Iran, Ethiopia, and India were the regions with the highest probability of infection. It was estimated that 5.3 billion people live in regions at risk ...
- Source: drugdu
- 99
- May 3, 2024
Genetic associations of key genes in breast cancer pathogenesis

Background and objectives Breast cancer remains a significant global health concern, warranting further exploration into its genetic basis and potential therapeutic targets. This study aimed to elucidate the genetic associations of seven pivotal genes with breast cancer and discern their potential role in disease prognosis. Methods The genes VEGFA, BRCA1, RAD51, CCNB1, CHEK1, CDK1, and XRCC4 were curated from over 30 articles. Their association with breast cancer was analyzed using both in silico and in vitro techniques. The in silico assessment involved constructing a protein-protein interaction network, accompanied by Gene Ontology and pathway enrichment analysis. Further, survival and expression analysis were conducted using Kaplan-Meier Plotter and the UALCAN database respectively. At the protein level, expression was observed using the Human Protein Atlas database. The in vitro validation involved analyzing mRNA expression levels in 10 breast cancer tissue samples. Results The study revealed that all seven genes are significantly upregulated in ...
- Source: drugdu
- 80
- May 2, 2024
Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator

Dive Brief Medtronic has received Food and Drug Administration approval for its Inceptiv closed-loop spinal cord stimulator (SCS) for the treatment of chronic pain, the company said Friday. The closed-loop system is meant to reduce overstimulation compared to the open-loop technology used by Medtronic’s rivals, such as Abbott, Boston Scientific and Nevro. Evercore ISI analysts think Medtronic has lost share to Abbott over the past two years, and the launch of Inceptiv could help the company regain ground in the coming quarters. Dive Insight Users of open-loop SCS receive a predetermined amount of stimulation, which is set when the physician programs the device, regardless of what the patient is doing. The fixed output can result in moments of overstimulation that are uncomfortable, potentially leading users to choose a lower, less effective level of stimulation. Open-loop efficacy may fall over time, too. Closed-loop systems, such as Medtronic’s Inceptiv device, adjust their ...
- Source: drugdu
- 75
- May 2, 2024
Six Biopharma Companies to Watch at MedCity INVEST Pitch Perfect Contest

The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, The companies will offer a window into some of the promising treatments under development such as different types of cancers to muscular dystrophy. Space is limited so register today! By Stephanie Baum Biopharma companies are responsible for some of the most transformative, life-changing technologies in medicine from gene therapy to immunotherapy. At the MedCity INVEST conference scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, six biopharma companies will give attendees a window into some of the promising treatments under development. MedCity News Senior Biopharma Reporter Frank Vinluan will moderate the biopharma track of the startup contest Pitch Perfect. One judge confirmed for the track is Meredith Wilkerson, an investment principal with Plains Ventures who serves as the primary subject matter expert for evaluating life sciences and biotech investment opportunities. Wilkerson will also ...
- Source: drugdu
- 95
- May 2, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 72
- May 2, 2024

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