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.

European Commission grants marketing authorization for Bayer HealthCare's Xofigo injection

Bayer HealthCare announced today that the European Commission has granted marketing authorization for Xofigo (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use in September of this year.

15 Nov 2013

Imbruvica gets FDA approval for treatment of mantle cell lymphoma

The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer.

13 Nov 2013

Multiple pregnancies: A major public health concern worldwide

Multiple pregnancies are a major public health concern in the United States and the rest of the world due to the significantly higher health risks for both mothers and infants, as well as the impact on healthcare costs.

11 Nov 2013

BioCryst Pharmaceuticals initiates BCX4161 Phase 2a trial in HAE patients

BioCryst Pharmaceuticals, Inc. today announced that it has dosed the first subject in OPuS-1 (Oral ProphylaxiS-1), a Phase 2a proof of concept clinical trial of orally-administered BCX4161 in patients with hereditary angioedema.

8 Nov 2013

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the presentation of interim data from a Phase 1B trial (PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy, in patients with previously-treated non-small cell lung cancer (NSCLC). The data were presented today by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, at the 15th World Conference on Lung Cancer in Sydney, Australia (Abstract #2416).

31 Oct 2013

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

ARIAD Pharmaceuticals, Inc. today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.

31 Oct 2013

Once-daily prescription medicine for COPD now available throughout the U.S.

GlaxoSmithKline plc and Theravance, Inc. today announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease, is now available to pharmacies throughout the U.S.

30 Oct 2013

Regeneron announces topline results from Phase 3 study of EYLEA Injection in patients with Macular Edema following BRVO

Regeneron Pharmaceuticals, Inc. today announced positive topline results for EYLEA® (aflibercept) Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO).

21 Oct 2013

Pfizer announces top-line results from phase 3b studies with Lyrica Capsules

Pfizer Inc. (NYSE:PFE) announced top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively.

19 Oct 2013

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products.

19 Oct 2013

ARIAD discontinues Phase 3 EPIC trial of Iclusig in patients with chronic myeloid leukemia

ARIAD Pharmaceuticals, Inc. today announced that it is discontinuing the Phase 3 EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial of Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid leukemia.

18 Oct 2013

pSivida reports that Alimera Sciences gets FDA Complete Response Letter for ILUVIEN NDA

pSivida Corp., a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that its licensee Alimera Sciences, Inc. has received a Complete Response Letter for the New Drug Application for ILUVIEN from the U.S. Food and Drug Administration.

18 Oct 2013

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation , today announced the results of the MPACT phase III clinical trial of ABRAXANE® in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

17 Oct 2013

Liposorber LA-15 System to treat pediatric patients with primary FSGS gets FDA approval

The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS.

11 Oct 2013

Running a marathon can damage heart muscle for unfit runners

Investigators who studied a group of recreational marathon runners have established that strenuous exercise such as running a marathon can damage the heart muscle. Although they found the effect is temporary and reversible, they warn that these effects are more widespread in less fit distance runners and that recreational distance runners should prepare properly before marathons.

10 Oct 2013

Adempas drug gets FDA approval for treatment of pulmonary hypertension

The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs.

10 Oct 2013

Allegro receives FDA IND approval to initiate Phase II clinical studies of ALG-1001 in AMD, VMT patients

Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to begin two Phase II clinical studies of ALG-1001.

10 Oct 2013

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

ARIAD Pharmaceuticals, Inc. today announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig® (ponatinib) and actions that it is taking following consultations with the U.S. Food and Drug Administration (FDA).

9 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in the second clinical trial of Glial Growth Factor 2 (GGF2). This Phase 1b single-infusion trial in people with heart failure will assess tolerability of three dose levels of GGF2, and also includes several explorative measures of efficacy.

9 Oct 2013

Edema News and Research

Further Reading

European Commission grants marketing authorization for Bayer HealthCare's Xofigo injection

Imbruvica gets FDA approval for treatment of mantle cell lymphoma

Multiple pregnancies: A major public health concern worldwide

BioCryst Pharmaceuticals initiates BCX4161 Phase 2a trial in HAE patients

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

Once-daily prescription medicine for COPD now available throughout the U.S.

Regeneron announces topline results from Phase 3 study of EYLEA Injection in patients with Macular Edema following BRVO

Pfizer announces top-line results from phase 3b studies with Lyrica Capsules

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

ARIAD discontinues Phase 3 EPIC trial of Iclusig in patients with chronic myeloid leukemia

pSivida reports that Alimera Sciences gets FDA Complete Response Letter for ILUVIEN NDA

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Liposorber LA-15 System to treat pediatric patients with primary FSGS gets FDA approval

Running a marathon can damage heart muscle for unfit runners

Adempas drug gets FDA approval for treatment of pulmonary hypertension

Allegro receives FDA IND approval to initiate Phase II clinical studies of ALG-1001 in AMD, VMT patients

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

Bayer HealthCare receives FDA approval for Adempas tablets

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

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