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

00:14 EDT 19th July 2018 | BioPortfolio

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Showing "CAFC affirms Apotex biosimilars infringe Amgen patent" PubMed Articles 76–100 of 220

Touching the Spirit: Re-enchanting the Person in the Body.

In this essay, we argue that touch constitutes a sacred connection between the patient and practitioner. When touch is avoided or overlooked, the enigmatic inner workings of the body are ignored as those aspects of the body that can be quantified and ultimately controlled are emphasized. In utilizing touch as a fundamental way of opening up space for the sacred, the practitioner affirms the humanity for both the patient and herself. Only by returning to the senses can practitioners resist the dehumanizing e...


Secondary patents in the pharmaceutical industry: Missing the wood for the trees?

Introduction The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed ...

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...


Biosimilars.

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.

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...

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...

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 ...

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.

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.

Concomitant coronary and pulmonary embolism associated with patent foramen ovale: A case report.

The differential diagnosis of acute chest pain is very important, and can sometimes be challenging. Related diseases share a number of risk factors, and occasionally, 1 condition causes another disease to develop.

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...

Paracetamol (acetaminofeno) intravenoso para cierre de conducto arterioso permeable en prematuros ≤ 32 semanas de gestación.

To identify the effectiveness of intravenous paracetamol for closure of patent ductus arteriosus in preterm ≤32 weeks gestation.

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...

Multiple Cerebral Infarctions Due to Patent Foramen Ovale in a Patient with Eosinophilic Granulomatosis with Polyangiitis.

A 51-year-old man was diagnosed with eosinophilic granulomatosis with polyangiitis 6 years ago due to asthma, sinusitis, hypereosinophilia, and peripheral neuropathy based on the diagnostic criteria of American College of Rheumatology, and corticosteroid therapy achieved a remission. One year ago, he was hospitalized due to deep venous thrombosis (DVT) and pulmonary embolism, and rivaroxaban was administrated. He was admitted to our hospital for acute onset of diplopia and right hemiparesis. Peripheral bloo...

A Rare Complication of Patent Ductus Arteriosus Ligation: Inadvertent Ligation of the Left Pulmonary Artery.

The inadvertent ligation of the left pulmonary artery (LPA) is a rarely seen surgical complication that has been presented in the literature in a limited number of cases after patent ductus arteriosus (PDA) ligation surgery. Case Report: A PDA closure operation was performed on our patient, a 28-week-old preterm. In the postoperative follow-up, we identified on echocardiography taken on the same postoperative day that the ductus space was still present. On CT angiography, we determined that not only was th...

Low-Dose Intravenous Paracetamol for Patent Ductus Arteriosus in Indomethacin-Resistant or Contraindicated Preterm Infants: Three Cases Reports.

Background  Although indomethacin (IND) is the standard treatment for hemodynamically significant patent ductus arteriosus (hsPDA) in Japan, it may be associated with renal impairment and gastrointestinal complications. The use of paracetamol for hsPDA closure has recently increased. Unlike IND, paracetamol does not have a peripheral vasoconstrictive effect and can be given to infants with contraindications to IND. Based on limited data available from randomized trials, paracetamol and IND seem to have si...

Preserving a patent DIEP pedicle to facilitate salvage breast reconstruction with a second free flap: A case report.

Surgeons performing free flap breast reconstruction need to have a range of techniques in their armamentarium to successfully salvage cases of flap failure. We present a case of 47-year-old patient who suffered near-total right breast deep inferior epigastric perforator (DIEP) flap failure 3 days post-bilateral immediate breast reconstruction with DIEP flaps. At debridement, the DIEP pedicle was noted to be patent with preserved perfusion to a small segment of tissue around the origin of the pedicle. This t...

Title: Studies on drug switchability showed heterogeneity in methodological approaches: a scoping review.

Several drugs share the same therapeutic indication, including those undergoing patent expiration. Concerns on the interchangeability are frequent in clinical practice, challenging the evaluation of switchability through observational research.

Anti-migraine and anti-depression activities of Tianshu capsule by mediating Monoamine oxidase.

Tianshu capsule(TSC)is a Chinese patent medicine. It's widely used to treat migraine clinically in China.

Cancer Breath Testing: A Patent Review.

Human breath can contain thousands of volatile organic compounds (VOCs) and semi-volatile compounds that are related to metabolism and other biochemical processes. The presence of cancer cells can affect the identity and abundances of chemicals in breath when compared to those in healthy control subjects, which can be used to indicate the likelihood of a patient having cancer. Recently, the chemical analysis of exhaled breath from patients has been shown to be promising for diagnosing many different types o...

A patent review of butyrylcholinesterase inhibitors and reactivators 2010-2017.

Butyrylcholinesterase (BuChE) has obtained a renewed interest as a therapeutic target in Alzheimer's disease (AD), when changes in BuChE activity and expression along disease progression were highlighted as well as correlation between BuChE levels and cognitive function. Areas covered. During the last seven years, fourteen patents on BuChE inhibitors (BuChEI) have been submitted. Only three of them relate to BuChE selective inhibitors, while four of them focus on multitarget inhibitors which address differe...

Patent Foramen Ovale and Hypoxemia.

Patent foramen ovale (PFO), an embryonic remnant of the fetal circulation, is present in 20-25% of adults. While recent observational studies and clinical trials have established the link between PFO-mediated right-to-left shunting with cryptogenic stroke and migraine with aura, the role of a PFO in exacerbating hypoxemic medical conditions (i.e., sleep apnea, chronic obstructive pulmonary disease, pulmonary hypertension, platypnea-orthodeoxia, pulmonary arteriovenous malformation, high altitude pulmonary e...

Cell fate reprogramming through engineering of native transcription factors.

Cellular reprogramming using cocktails of transcription factors (TFs) affirms the epigenetic and developmental plasticity of mammalian cells. It demonstrates the ability of TFs to 'read' genetic information and to rewire regulatory networks in different cellular contexts. Silenced chromatin is not an impediment to the genome engagement by ectopically expressed TFs. Reprogramming TFs have been identified in diverse structural families that lack shared domains or sequence motifs. Interestingly, the reprogramm...

Tissue-engineered submillimeter-diameter vascular grafts for free flap survival in rat model.

Vascular grafts for free flap transfers should be of very small diameter and remain patent for approximately three weeks to supply blood until the revascularization from the surrounding tissue is established, with the autologous vein grafts acting as the gold standard. Artificial submillimeter-diameter vascular grafts with clinically useful size of 0.6 mm inner diameter and 5 cm length were prepared and evaluated by replacing the axial artery of free flap in rats. The rat tail artery, selected as a nove...


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