PubMed Journals Articles About "CAFC Affirms Apotex Biosimilars Infringe Amgen Patent" - Page: 4 RSS

06:06 EDT 23rd September 2018 | BioPortfolio

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Showing "CAFC affirms Apotex biosimilars infringe Amgen patent" PubMed Articles 76–100 of 241

Patent foramen ovale (PFO) closure versus medical therapy for prevention of recurrent stroke in patients with prior cryptogenic stroke: A systematic review and meta-analysis of randomized controlled trials.

We performed a systematic review and meta-analysis of randomized controlled trials to assess the effect of closure of a patent foramen ovale (PFO) compared with medical therapy for the prevention of stroke in patients with prior cryptogenic stroke.

Nanoengineered delivery systems for cancer imaging and therapy: recent advances, future directions and patent evaluation.

Cancer is the second-highest cause of death worldwide. Several therapeutic approaches, such as conventional chemotherapy, antibodies and small-molecule inhibitors and nanotherapeutics, have been employed in battling cancer. Among them, nanotheranostics is an example of successful personalized medicine bearing the dual role of early diagnosis and therapy to cancer patients. In this review, we focus on various types of theranostic polymer and metal nanoparticles for their roles in cancer therapy and imaging c...

Cerebral infarction following cyanoacrylate endoscopic therapy of duodenal varices in a patient with a patent foramen ovale.

Patent foramen ovale with an enormous right-to-left shunt: unusual reversible cause of hypoxia in carcinoid syndrome.

Falciform Ligament Artery Uptake on 99mTc MAA Planning Scan Before 90Y SIRT Confirmed by Retrospective SPECT/MRI Fusion.

Selective internal radiation therapy using Y spheres is a treatment option for patients with primary or secondary liver cancer. To avoid complications, screening using Tc macroaggregated albumin is performed to identify lung shunting and extrahepatic depositions. For the latter, deposition after the anterior abdominal wall is frequently attributed to a patent falciform artery, although the vessel itself is rarely visible on SPECT/CT scans. We demonstrate that retrospective SPECT/MRI fusion clearly attribute...

Transcatheters for Closure of Patent Foramen Ovales.

Nowadays patent foramen ovale (PFO) closure is considered clinically beneficial and even cost-effective over medical therapy in secondary prevention of stroke due to paradoxical embolism. Areas Covered: In this review, the authors discuss both anatomical and technical details and constructive concepts of current devices used for PFO closure. Expert Commentary: Right atrial and interatrial septum anatomy is more complex than usually thought and a unique prosthesis that fits properly to all the possible morph...

Clarifying Our Understanding of Biosimilars in Oncology: Response to ASCO Statement.

Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study.

Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007.

Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial.

Haemodynamically significant patent ductus arteriosus (hsPDA) is a common cause of mortality and morbidity in preterm infants. Existing medical therapies with ibuprofen or indomethacin have multiple adverse effects. Hence, an alternative drug like paracetamol given through oral route with less side effects need to be tested in an appropriate study design with least risk of bias to arrive at a conclusion.

Further Promotion of Stroke Treatment with Delayed or Unknown Time of Onset but Smaller Benefit from Patent Foramen Ovale Closure than Pre-Applauded.

Local Administration of Interleukin-1 Receptor Antagonist Improves Diabetic Wound Healing.

Impaired healing of the skin is a notable cause of patient morbidity and mortality. In diabetic individuals, dysregulated inflammation contributes to delayed wound healing. Specific immunomodulatory agents may have a role in the treatment of diabetic wounds. One of these molecules is interleukin-1 receptor antagonist (Anakinra; Amgen Corp.). Although interleukin-1 receptor antagonist (Anakinra; Amgen Corp.) is approved by the Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis and n...

Incomplete endothelialization of an intravascular implant and fatal late-onset bacterial ductal arteritis in a dog with occluded patent ductus arteriosus.

An 18-month-old male Akita Inu dog developed fever and lameness 8 months after successful transcatheter closure of a patent ductus arteriosus with an Amplatz Canine Duct Occluder (ACDO). Corynebacterium species were cultured from 3 blood samples. Echocardiography showed a vegetative process on the aortic valves. The dog died spontaneously 3 days after development of the initial signs. Necropsy confirmed the presence of bacterial ductal arteritis and myocarditis, and revealed an incomplete endothelialization...

Patent foramen ovele, good reasons to close it.

A patent foramen ovale (PFO) is not to be considered a disease as it is present in about 25 % of people. Yet, it is the prime reason for paradoxical embolism that can cause serious problems, such as death, stroke, myocardial infarction, and peripheral ischemia. The frequency of such events is probably underestimated as other causes tend to be blamed for them. Device PFO closure can be easily accomplished as outpatient procedure with minimal discomfort and risk and it has been referred to as mechanical vac...


Biologics have had an enormous impact on the practice of medicine. In cancer, checkpoint inhibitors have dramatically improved survival, including in melanoma. In chronic inflammatory diseases their impact has been similarly impressive. To date in dermatology this has mainly been felt in the management of severe psoriasis. This article is protected by copyright. All rights reserved.

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke.

Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of ...

Contrast Transthoracic Echocardiography Using 50% Glucose as a Contrast Agent for Screening of a Patent Foramen Ovale.

A patent foramen ovale (PFO) is considered a risk factor for neurologic events. The goal of the study described here was to assess the feasibility, advantages, diagnostic sensitivity and accuracy of contrast transthoracic echocardiography examination (cTTE) using 50% glucose as a contrast agent in comparison with the use of agitated saline as contrast to screen for PFO. In our study, we found that the peak time, effective duration and duration of microbubbles produced by 50% glucose were all longer than tho...

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original  biotechnological medicine, whose patent has expired, and they comply with the  guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference on...

Plagiarism in Scientific Publishing - the Issue of Patent Holder (War Between Developed and Undeveloped Countries) - Letter to Editor.

A closer look at blinatumomab.

On March 29, 2018, blinatumomab (Blincyto, Amgen) received an accelerated expanded approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in first or second complete remission (CR) and have minimal residual disease (MRD). Blinatumomab was first approved for use in adult patients (in December 2014) and later in pediatric patients (in September 2016) with relapsed or refractory Philadelphia chromosome (Ph)-negative B-cell precursor ALL; the ...

End of life liquid crystal displays recycling: A patent review.

A huge quantity of end-of-life liquid crystal displays (LCD) is collected, every year, around the world. Nowadays, this equipment is disassembled, for the removal of hazardous components (e.g. the backlight fluorescent lamps), and the resulting panel is stored. The reason is the significant content of valuable fractions (e.g. glass, metals and liquid crystals) and the lack of a recycling process, sustainable from an economic and an environmental point of view. Considering the relevance of this critical issu...

Elevated blood pressure and its predictors among secondary school students in Sarawak: a cross-sectional study.

Hypertension is a health issue affecting adolescents. Accumulating evidence affirms that elevated blood pressure begins in childhood and tracks into adulthood. This cross-sectional study was conducted to determine the prevalence of elevated blood pressure and its predictors among secondary school students in Sarawak, Malaysia.

Carbonic anhydrase enzymes for regulating mast cell hematopoiesis and type-2 inflammation: a patent evaluation (WO2017/058370).

Activity modulators of carbonic anhydrases hold great potential for several therapeutic applications against ophthalmologic and neurological disease, cancer and infectious diseases. The involvement of carbonic anhydrase in the regulation of mast cell response opens new ways for the treatment of mastocytosis, allergic inflammation and parasite infection Areas covered: The application claims the use of carbonic anhydrase activity modulators (inhibitors or activators) for treating allergic disease, bacterial i...

Large thrombus-in-transit within a patent foramen ovale in a patient with pulmonary embolism: a case report.

Objective A patent foramen ovale (PFO) is detected frequently by echocardiography. However, a thrombus trapped in a PFO is relatively rare. We herein describe a rare case of a 51-year-old patient with pulmonary embolism in which a large thrombus-in-transit through a PFO was found by echocardiography and disappeared after treatment. Methods A 51-year-old woman presented with a 1-week history of chest tightness, unspecified chest pain, and shortness of breath. Echocardiography revealed a large thrombus trappe...

FDA Expectations for Demonstrating Interchangeability.

There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expec...

Transcatheter closure of atrial septal communication: impact on P-wave dispersion, duration and arrhythmia in mid-term follow-up.

Atrial septal communications (ASC) include atrial septal defects (ASD) and patent foramen ovale (PFO).

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