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.

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire plc, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association 166th Annual Meeting in San Francisco, May 18-22.

20 May 2013

Boehringer Ingelheim updates HCPs, patients on COMBIVENT RESPIMAT Inhalation Spray

As part of the company's commitment to chronic obstructive pulmonary disease patients, Boehringer Ingelheim Pharmaceuticals, Inc., a leader in respiratory health, is updating healthcare professionals and patients that the transition to COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray for the maintenance treatment of COPD is nearly complete.

18 May 2013

Biocryst reports financial results for first quarter 2013

BioCryst Pharmaceuticals, Inc. announced financial results for the first quarter ended March 31, 2013.

7 May 2013

Merck, Pfizer sign collaboration agreement for development and commercialization of ertugliflozin

Merck & Co., Inc., known as MSD outside the United States and Canada, and Pfizer Inc. today announced that they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of type 2 diabetes.

From Pfizer, Inc. 30 Apr 2013

Dyax reports Q1 2013 financial results; LFRP portfolio continues to be a growth driver

Dyax Corp. today announced financial results for the first quarter ended March 31, 2013. The Company will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and updates regarding its key value drivers - the KALBITOR® (ecallantide) business, the broader angioedema portfolio and the Licensing and Funded Research Program (LFRP).

26 Apr 2013

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection.

24 Apr 2013

ViroPharma announces results of VP20621 Phase 2 study for preventing recurrent CDI

ViroPharma Incorporated, an international biopharmaceutical company committed to developing and commercializing innovative products that address unmet medical needs and rare diseases, today announced the results of a Phase 2 study of VP20621 (non-toxigenic Clostridium difficile; NTCD) a novel treatment approach for preventing recurrent C. difficile infections.

23 Apr 2013

Santarus, Pharming Group submit Biologics License Application to FDA for RUCONEST

Santarus, Inc. and Pharming Group NV today announced the submission of a Biologics License Application to the U.S. Food and Drug Administration to obtain marketing approval for RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema.

17 Apr 2013

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck's investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting.

11 Apr 2013

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

4 Apr 2013

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

BioCryst Pharmaceuticals, Inc. announced that it received a preliminary comment letter from the U.S. Food & Drug Administration that outlines a pathway by which BioCryst could file a New Drug Application seeking regulatory approval of intravenous (i.v.) peramivir.

1 Apr 2013

BioCryst starts BCX4161 Phase 1 clinical trial for treatment of hereditary angioedema

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX4161 in healthy volunteers.

25 Mar 2013

Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

From Baxter International Inc. 26 Feb 2013

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen, immune globulin intravenous [human].

21 Feb 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

Angioedema News and Research

Further Reading

European Commission amends marketing authorisation for Celgene's REVLIMID

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Boehringer Ingelheim updates HCPs, patients on COMBIVENT RESPIMAT Inhalation Spray

Biocryst reports financial results for first quarter 2013

Merck, Pfizer sign collaboration agreement for development and commercialization of ertugliflozin

Dyax reports Q1 2013 financial results; LFRP portfolio continues to be a growth driver

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

ViroPharma announces results of VP20621 Phase 2 study for preventing recurrent CDI

Santarus, Pharming Group submit Biologics License Application to FDA for RUCONEST

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

BioCryst starts BCX4161 Phase 1 clinical trial for treatment of hereditary angioedema

Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

BioCryst fourth quarter revenues decrease to $4.1 million

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Dyax fourth quarter total revenues increase to $16.0 million

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Advancing Intracellular Delivery with LumiPore®

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