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.

Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Dyax Corp. and CMIC Co., Ltd, announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

Santarus, Inc., a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.

13 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

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

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

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

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 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

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

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

ViroPharma Incorporated today announced that data from Phase 3 studies of Cinryze (C1 esterase inhibitor [human]) have been published in the August 5, 2010 issue of the New England Journal of Medicine. The paper entitled Nanofiltered C1 Inhibitor Concentrate for Treatment of Hereditary Angioedema by Dr. Bruce L. Zuraw et al. describes the safety and efficacy of Cinryze in treating and preventing attacks of hereditary angioedema. Cinryze is the first and only FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease; it is not approved by the FDA to treat acute angioedema attacks.

6 Aug 2010

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Dyax Corp. announced today that results from EDEMA3, the Company's first Phase 3 trial evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema, were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.

6 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Dyax second-quarter total revenues increase to $15.1 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2010.

28 Jul 2010

ViroPharma second-quarter net sales increase 33% to $109.0 million

ViroPharma Incorporated reported today its financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Dyax Corp. today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

20 Jul 2010

EMA completes validation process for Dyax's ecallantide MAA

Dyax Corp. announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU).

6 Jul 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

Angioedema News and Research

Further Reading

Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

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

FDA approves Novartis' Tekamlo for treatment of high blood pressure

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

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Tasigna receives approval for chronic myeloid leukemia in Canada

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

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Dyax second-quarter total revenues increase to $15.1 million

ViroPharma second-quarter net sales increase 33% to $109.0 million

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

EMA completes validation process for Dyax's ecallantide MAA

Merck challenges New York jury decision in federal FOSAMAX retrial

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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