Edema News and Research

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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.

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

ThromboGenics second microplasmin Phase III trial for non-surgical treatment of VMA meets primary endpoint

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint.

2 Sep 2010

FDA approves LUMIGAN eye drops for intraocular pressure reduction in open-angle glaucoma patients

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

2 Sep 2010

PDL BioPharma reports revenue guidance of $86 million for 2010 third quarter

PDL BioPharma, Inc. today announced revenue guidance for the third quarter ended September 30, 2010 of approximately $86 million, as compared with actual results of $71.4 million for the third quarter of 2009, a 20 percent year-over-year increase.

2 Sep 2010

pSivida announces FDA Priority Review status for Iluvien NDA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

31 Aug 2010

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

FDA grants Priority Review status to Alimera Sciences' Iluvien for diabetic macular edema

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that the Company's New Drug Application (NDA) for Iluvien® (fluocinolone acetonide intravitreal insert) has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA).

31 Aug 2010

FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

27 Aug 2010

Amneal Pharmaceuticals receives FDA approval for Spironolactone HCl tablets

Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010.

26 Aug 2010

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, today announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure.

26 Aug 2010

CreAgri receives patent for Hydroxytyrosol for skin damage by UV exposure

CreAgri, Inc. announced today that the company has received a Patent by the Australian Patent Office, Patent Number 2003249719, which covers the protective effects provided by Hydroxytyrosol against skin damage caused by UV exposure.

26 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Whole body MRI may help to diagnose suspected child abuse: Study

Whole-body magnetic resonance imaging (MRI), which is highly accurate at detecting soft-tissue abnormalities, may serve a role in detecting suspected child abuse in infants, according to a study in the September issue of the American Journal of Roentgenology.

21 Aug 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010

Immunosuppressive therapy benefits necrotizing myopathy patients with novel autoantibody specificity

Researchers at Johns Hopkins University School of Medicine have identified a subgroup of patients with necrotizing myopathy who have a novel autoantibody specificity that makes them potential candidates for immunosuppressive therapy. The complete study is published in the September issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

20 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Quark enters licensing option agreement with Novartis for p53 temporary inhibitor siRNA drug QPI-1002

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that it has granted Novartis an option to obtain an exclusive worldwide license to develop and commercialize its p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase II clinical trial.

18 Aug 2010

Alimera Sciences second-quarter net loss decreases to $4.8 million

Alimera Sciences, Inc., today announced financial results for the second quarter ended June 30, 2010 and provided an update on progress toward achieving its 2010 goals.

13 Aug 2010

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Genmab A/S announced today top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant.

11 Aug 2010

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 Aug 2010

Edema News and Research

Further Reading

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

ThromboGenics second microplasmin Phase III trial for non-surgical treatment of VMA meets primary endpoint

FDA approves LUMIGAN eye drops for intraocular pressure reduction in open-angle glaucoma patients

PDL BioPharma reports revenue guidance of $86 million for 2010 third quarter

pSivida announces FDA Priority Review status for Iluvien NDA

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

FDA grants Priority Review status to Alimera Sciences' Iluvien for diabetic macular edema

FDA approves Novartis' Tekamlo for treatment of high blood pressure

Amneal Pharmaceuticals receives FDA approval for Spironolactone HCl tablets

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

CreAgri receives patent for Hydroxytyrosol for skin damage by UV exposure

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Whole body MRI may help to diagnose suspected child abuse: Study

Tasigna receives approval for chronic myeloid leukemia in Canada

Immunosuppressive therapy benefits necrotizing myopathy patients with novel autoantibody specificity

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Quark enters licensing option agreement with Novartis for p53 temporary inhibitor siRNA drug QPI-1002

Alimera Sciences second-quarter net loss decreases to $4.8 million

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

The Critical Role of Sample Storage in Drug Discovery and Development

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

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