The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

开始日期2011-04-01

申办/合作机构

PolyMedix, Inc.

100 项与 Delparantag 相关的临床结果

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100 项与 Delparantag 相关的转化医学

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100 项与 Delparantag 相关的专利（医药）

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项与 Delparantag 相关的文献（医药）

2014-04-01·Journal of thrombosis and thrombolysis4区 · 医学

A 1-year drug utilization evaluation of protamine in hospitalized patients to identify possible future roles of heparin and low molecular weight heparin reversal agents

4区 · 医学

Article

作者: Mahan, Charles E

Despite widespread use of unfractionated heparin (UFH) and low molecular weight heparin (LMWH), protamine sulfate remains the only reversal agent for UFH that is approved by the Food and Drug Administration within the US. Availability of new reversal agents for approved anticoagulants and those in development may improve patient safety and care. Delparantag (PMX-60056) is a novel small molecule that shows ability to neutralize the anticoagulation effects of UFH and LMWH in animals and humans. This study examined the 1-year utilization of protamine within an acute care hospital in order to determine the need for a novel reversing agent like delparantag. All patients having documented protamine administration within a 1-year period were included. Pharmacy automated dispensing machines and computerized medication management systems were queried for all doses of protamine withdrawn, billed for, or dispensed. Scanned medical records were reviewed and protamine and anticoagulant information was abstracted. Primary procedural group categorizations for protamine patients were coronary artery bypass graft, cardiac valve surgeries, abdominal aortic aneurysm and other open abdominal surgeries, fistula placement, non-cardiac vascular, cardiac catheter and electrophysiology lab, and "other." Average doses of protamine administered were 439, 423, 126, 26, 46, 36, and 35 mg in these groups, respectively. Four major bleeds and one serious adverse event occurred over the year period. Protamine is used in a wide array of procedures. Evaluating protamine's current use may be beneficial in identifying roles for future UFH and LMWH reversal agent use.

2010-08-01·Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis4区 · 医学

In Vivo Neutralization of Unfractionated Heparin and Low-Molecular-Weight Heparin by a Novel Salicylamide Derivative

4区 · 医学

Article

作者: Jeske, Walter ; Hoppensteadt, Debra A. ; Kuziej, Jacqueline ; Dahui Liu ; Walenga, Jeanine M. ; Fareed, Jawed ; Litinas, Evangelos

Unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) are widely used anticoagulants for surgical and interventional use. Currently, the anticoagulant and bleeding effects of heparin are neutralized by protamine sulfate. There are several problems associated with the use of protamine sulfate, including allergic reactions, cardiovascular effects, heparin rebound, and incomplete neutralization of LMWHs. The objective of this investigation is to characterize the effectiveness of a novel salicylamide-derived heparin antagonist, PMX 60056, in neutralizing the antithrombotic and bleeding effects of UFH and LMWHs. Animals were first anticoagulated using an intravenous injection of UFH or LMWH followed by protamine sulfate or PMX 60056. Established animal models of hemorrhage (rat-tail transection) and thrombosis (jugular vein clamping) were then performed. Blood samples were collected for ex vivo analysis using activated partial thromboplastin time (aPTT), anti-Xa, and anti-IIa assays. We demonstrate that PMX 60056 neutralized the antithrombotic, anticoagulant, and bleeding effects of heparins as effectively as protamine sulfate and may be slightly more efficacious against LMWHs. These results suggest that PMX 60056 may provide an improved approach for the neutralization of UFH and LMWHs.

项与 Delparantag 相关的新闻（医药）

2023-07-04

·Pharmaceutical Technology

Amneal receives Xyrem generic approval after patent disputes

Akosua Mireku @AkosuaMireku1 Amneal is an American generics and speciality pharmaceutical company. Credit: JHVEPhoto via Shutterstock. US-based Amneal Pharmaceuticals has announced the US launch of its authorised generic for Ireland’s Jazz Pharmaceuticals’ Xyrem (sodium oxybate) after previous legal clashes. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. In a company announcement on 3 July, Amneal also announced the recent US Food and Drug Administration (FDA) approval of five complex generics in Q2 2023. Recommended Reports Reports LOA and PTSR Model - Omiganan Pentahydrochloride in Genital Warts (Condylomata Acuminata) GlobalData Reports LOA and PTSR Model - Omiganan Pentahydrochloride in Seborrhea GlobalData View all Companies Intelligence Pfizer Inc Jazz Pharmaceuticals Plc Amneal Pharmaceuticals Inc Almirall SA C R L Inc View all This includes its generic versions of Pfizer’s Depo-Provera (medroxyprogesterone acetate), Pfizer ’s Precedex (dexmedetomidine hydrochloride) and Novartis ’ Arranon (nelarabine), Almirall’s Aczone (dapsone), and Organon’s Nasonex (mometasone furoate). Xyrem is a treatment that acts as a central nervous system depressant in cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy. Amneal’s sodium oxybate generic joins a wave of others following a patent expiry of Jazz’s narcolepsy drug. In 2019, Jazz Pharmaceuticals attempted to dispute the patent via a US Court of Appeals lawsuit opposing the FDA’s approval of a rival narcolepsy drug Avadel’s Lumryz. However, the regulatory agency won the lawsuit in February 2023, forcing the company to delist a patent related to Xyrem, thus opening the door for the successful approval of more Xyrem generics. Jazz Pharmaceuticals received US approval for Xyrem in October 2002, making it the first and only medicine approved in the indication, with the label being expanded to treat excessive daytime sleepiness in 2005. Despite its approval, sodium oxybate is associated with serious safety concerns such as seizures, comas and death. As a result, the FDA restricts the prescription of the therapy under the Risk Evaluation and Mitigation Strategy (REMS) programme. This means that the drug can only be prescribed by a certified prescriber and can only be given to an enrolled patient by a certified pharmacy. It is not currently available in retail pharmacies. In the 30 June press release , Amneal’s co-CEOs Chirag and Chintu Patel said: “By adding these new medicines to our portfolio, Amneal is on track to launch more than 30 new generics products this year.” The biotech launched 26 new generic products last year and received an ANDA for its generic version of Narcan (naloxone hydrochloride) in March 2023. In addition, the FDA recently issued a complete response letter (CRL) to Amneal’s Parkinson’s disease treatment IPX203. The CRL requested further pharmacokinetic data from the company. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

上市批准生物类似药专利到期专利侵权

2023-06-13

·Pharmaceutical Technology

US FDA approves Ironwood Pharmaceuticals’ LINZESS

LINZESS is approved as a once-daily treatment for functional constipation in paediatric patients between six and 17 years of age. Credit: Charlein Gracia on Unsplash. The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years. Developed and marketed by AbbVie and Ironwood in the US, LINZESS was previously approved to treat irritable bowel syndrome with constipation or chronic idiopathic constipation in adult patients. Recommended Reports Reports LOA and PTSR Model - Omiganan Pentahydrochloride in Seborrhea GlobalData Reports LOA and PTSR Model - Omiganan Pentahydrochloride in Genital Warts (Condylomata Acuminata) GlobalData View all Companies Intelligence AbbVie Inc Ironwood Pharmaceuticals Inc View all It is the first and only prescription therapy to receive approval from the US FDA for functional constipation in paediatric patients. Ironwood Pharmaceuticals CEO Tom McCourt stated: “Today, Ironwood has broken new ground again in the history of LINZESS, extending the clinical utility of our blockbuster treatment to six to 17-year-olds seeking relief for functional constipation, a debilitating condition. “This approval is a momentous step forward in progressing our mission to advance the treatment of GI diseases and redefine the standard of care for GI patients and in ushering in a new era of growth for our company.” The regulatory approval was based on the findings obtained from a double-blind, multi-centre Phase III trial conducted in 328 functional constipation patients. Treatment with linaclotide demonstrated a statistically significant and clinically meaningful improvement in the 12-week spontaneous bowel movement (SBM) frequency rate against placebo. They also showed a more than two-fold least squares mean [LSM – a statistical method used to find or estimate the numerical values of parameters to fit a function to a set of data] change from baseline to 2.6 SBMs per week versus 1.3 SBMs per week with placebo.

上市批准临床3期临床结果寡核苷酸

2023-05-30

·Pharmaceutical Technology

Sun Pharma and Philogen sign licence agreement for anti-cancer therapy

Malignant melanoma on the right upper medial back, marked for biopsy. Credit: Dermanonymous / commons.wikimedia.org. Sun Pharmaceutical Industries has reached a licence agreement with Philogen for the commercialisation of Philogen’s Nidlegy (Daromun) in Australia, New Zealand and Europe. Nidlegy is a new anti-cancer biopharmaceutical being developed to treat patients with melanoma and non-melanoma skin cancers. It is currently undergoing Phase III clinical studies. Recommended Reports Reports LOA and PTSR Model - Omiganan Pentahydrochloride in Vulvar Cancer GlobalData Reports LOA and PTSR Model - Tivozanib Hydrochloride in Pancreatic Cancer GlobalData View all Nidlegy is composed of L19TNF and L19IL2, two active ingredients which are produced separately and then combined before being administered via the intralesional method. Philogen CEO and CSO Professor Dr Dario Neri stated: “This collaboration will focus on the commercialisation of Nidlegy, a new immunotherapy that brings promise to improve the therapeutic options for patients suffering from melanoma and non-melanoma skin cancers, high-risk conditions with unmet medical need.” Sun Pharma has been granted exclusive commercialisation rights for Nidlegy in the three countries for the treatment of skin cancers. Philogen will hold intellectual property rights for Nidlegy in other territories and indications, excluding skin cancers. It intends to conclude pivotal clinical studies for Nidlegy in Europe and to seek marketing authorisation from the regulatory authorities. The company will also be involved in the manufacture of commercial supplies. Sun Pharma will take responsibility for the commercialisation of the product. Post-commercialisation costs will be split equally between the two companies. Sun Pharma Western Europe and ANZ business head Hellen De Kloet stated: “This collaboration is in line with our goal to bring innovative products to patients. “With the expected addition of Nidlegy to our existing Odomzo franchise, we will be well-positioned to provide patient solutions across a broad spectrum of skin cancers in various disease stages.”