Angioedema News and Research

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Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis.

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

7 Nov 2012

BioCryst announces withdrawal of BCX5191 IND following discussion with FDA

BioCryst Pharmaceuticals, Inc. announced the withdrawal of its Investigational New Drug application (IND) for the antiviral nucleoside, BCX5191, following a discussion with the U.S. Food and Drug Administration (FDA).

31 Oct 2012

FDA accepts Sunovion’s two LATUDA sNDAs for review

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).

31 Oct 2012

BioRx added to Zemaira distribution network

BioRx, a national specialty pharmacy and infusion services provider, has been added to the limited distribution network for Zemaira [alpha-1 proteinase inhibitor (human)]. Zemaira is indicated for chronic augmentation and maintenance therapy in individuals with alpha1-antitrypsin (AAT) deficiency and clinical evidence of emphysema.

30 Oct 2012

AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

AstraZeneca today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population.

29 Oct 2012

Positive results from Santarus rifamycin SV MMX Phase III study on travelers' diarrhea

Santarus, Inc. today announced that its Phase III clinical study to evaluate the safety and efficacy of the investigational drug, rifamycin SV MMX, met the primary endpoint of reducing time to last unformed stool (TLUS) in patients with travelers' diarrhea.

12 Sep 2012

AMAG receives Swiss marketing authorization for ferumoxytol to treat iron deficiency anemia

AMAG Pharmaceuticals, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

6 Sep 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

BioCryst Pharmaceuticals, Inc. announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment.

25 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

Top-line results in Pfizer's Lyrica long term safety study for Generalized Anxiety Disorder

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules Study A0081147 - Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) - demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients.

23 Jul 2012

Bayer, Onyx and Astellas announce results from Tarceva plus Nexavar Phase 3 trial on HCC

Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc., and Astellas Pharma Inc. today announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone.

23 Jul 2012

Delaware district court upholds Pfizer's patents for LYRICA to treat pain and seizures

Pfizer Inc. announced today that the United States District Court for the District of Delaware upheld its composition of matter patent and pain and seizure use patents covering LYRICA (pregabalin) capsules CV. With this decision, Pfizer will exclusively provide pregabalin as LYRICA to patients through December 30, 2018 in the U.S., pending generic company appeal and further litigation.

20 Jul 2012

Dyax second quarter 2012 total revenues increase to $14.0 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2012.

20 Jul 2012

Positive preliminary results from Feraheme phase III study on iron deficiency anemia

AMAG Pharmaceuticals, Inc. today reported preliminary results from the second phase III study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause.

19 Jul 2012

Ampio announces results from Optina trial on DME

Ampio Pharmaceuticals, Inc., a biopharmaceutical company developing innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction and conducting clinical trials on its three lead drugs (Ampion, Optina & Zertane), announced the significant results from their further analysis of its Optina trial on DME.

9 Jul 2012

EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

23 Jun 2012

Pfizer receives FDA approval for Lyrica to manage neuropathic pain associated with SCI

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury.

22 Jun 2012

Dyax to discontinue ecallantide Phase 2 trial for ACE inhibitor-induced angioedema

Dyax Corp. announced today the decision to discontinue the Company's Phase 2 trial investigating ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema based upon the results of an interim analysis.

15 Jun 2012

Ampio’s CRO completes Optina clinical trial for DME

Ampio Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.

11 Jun 2012