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Edema means swelling caused by fluid in your body's tissues. It usually occurs in the feet, ankles and legs, but it can involve your entire body.
Par Pharmaceutical starts shipment of generic version of Sodium Edecrin

Par Pharmaceutical starts shipment of generic version of Sodium Edecrin

Par Pharmaceutical today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50 mg. [More]
Shire acquires Foresight Biotherapeutics for $300 million

Shire acquires Foresight Biotherapeutics for $300 million

Shire plc announced today that it has acquired New York-based, privately held Foresight Biotherapeutics Inc. for $300 million. [More]
Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections. [More]
CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications. [More]
Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis today announced the US Food and Drug Administration has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. [More]
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. [More]
KalVista raises $33 million in Series B financing to support development of plasma kallikrein inhibitors

KalVista raises $33 million in Series B financing to support development of plasma kallikrein inhibitors

KalVista Pharmaceuticals, a research-led pharmaceutical company, today announced it has raised $33 million in a Series B financing to support its research and clinical development programs. KalVista will use the funds to advance its proprietary portfolio of plasma kallikrein inhibitors for treating diabetic macular edema (DME) and hereditary angioedema (HAE). [More]
Penn study suggests future precision medicine approach to treating diabetes, other metabolic disorders

Penn study suggests future precision medicine approach to treating diabetes, other metabolic disorders

In the first study of its kind, Penn researchers have shown how an anti-diabetic drug can have variable effects depending on small natural differences in DNA sequence between individuals. Mitchell Lazar, MD, PhD, Raymond Soccio, MD, PhD, and colleagues at the Perelman School of Medicine at the University of Pennsylvania, aim to apply this knowledge to develop personalized approaches to treating diabetes and other metabolic disorders. [More]
Athletes need to drink when thirsty to avoid exercise-associated hyponatremia

Athletes need to drink when thirsty to avoid exercise-associated hyponatremia

For hikers, football players, endurance athletes, and a growing range of elite and recreational exercisers, the best approach to preventing potentially serious reductions in blood sodium level is to drink when thirsty, according to an updated consensus statement on exercise-associated hyponatremia (EAH). [More]
Bayer Yakuhin receives MHLW approval in Japan for EYLEA (aflibercept) Injection to treat RVO patients

Bayer Yakuhin receives MHLW approval in Japan for EYLEA (aflibercept) Injection to treat RVO patients

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., received approval for EYLEA (aflibercept) Injection by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO). [More]
The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

Eli Lilly and Company announced that The Lancet Oncology has published results of the Phase III REACH trial that evaluated CYRAMZA (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant. [More]
Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan plc, a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion. [More]

Bayer HealthCare, Johns Hopkins University to jointly develop new ophthalmic therapies targeting retinal diseases

The Johns Hopkins University and Bayer HealthCare have entered into a five-year collaboration agreement to jointly develop new ophthalmic therapies targeting retinal diseases. The goal of the strategic research alliance is to accelerate the translation of innovative approaches from the laboratory to the clinic, ultimately offering patients new treatment options for several retinal diseases. [More]
ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Novartis today announced new data from two Phase II studies of Zykadia (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist (trametinib) in certain patients with non-small cell lung cancer. [More]
Medicare physician reimbursement data could be confusing to the public

Medicare physician reimbursement data could be confusing to the public

The Centers for Medicare & Medicaid Services today released to the public data relating to 2013 Medicare payments made to physicians and other providers. In response, the American Academy of Ophthalmology is providing necessary context for the reimbursement data, which in its raw form are often complex and difficult to understand. [More]
Enzalutamide Phase 2 study for AR positive triple-negative breast cancer meets primary endpoint

Enzalutamide Phase 2 study for AR positive triple-negative breast cancer meets primary endpoint

Astellas Pharma Inc. announced that data from a Phase 2 study evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced androgen receptor (AR) positive, triple-negative breast cancer (TNBC) were presented during an oral abstracts session at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. [More]
Abbvie presents venetoclax Phase 1 results in patients with multiple myeloma at ASCO 2015

Abbvie presents venetoclax Phase 1 results in patients with multiple myeloma at ASCO 2015

AbbVie, a global biopharmaceutical company, today announced that results from a Phase 1b trial of investigational venetoclax, a novel inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, in combination with bortezomib and dexamethasone, showed an 83 percent overall response rate (n=5/6) in bortezomib-naive patients with relapsed/refractory (R/R) multiple myeloma, including two patients who achieved complete responses.1 These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31, in Chicago. [More]
Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

Novartis today announced data from the Phase III COMBI-d study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar monotherapy alone. [More]
Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis® (carfilzomib) for Injection administered once-weekly with dexamethasone versus the current U.S. Food and Drug Administration (FDA) approved twice-weekly administration schedule in patients with relapsed and refractory multiple myeloma who have received prior treatment with bortezomib and an immunomodulatory agent (IMiD). [More]
CHEMOSAT treatment of UM patients with hepatic metastases highlighted at ASCO 2015

CHEMOSAT treatment of UM patients with hepatic metastases highlighted at ASCO 2015

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that results of a large, European single-center experience of the treatment of uveal melanoma patients with hepatic metastases with the Delcath Hepatic CHEMOSAT® Delivery System, were highlighted in an on-line abstract at the American Society of Clinical Oncology Annual Meeting 2015. [More]
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