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.

TherapeuticsMD announces FDA approval of BIJUVA capsules to manage vasomotor symptoms of menopause

TherapeuticsMD, Inc., an innovative women's healthcare company, today announced that the United States Food and Drug Administration has approved BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

29 Oct 2018

New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug

HealthCore, Inc., the outcomes research subsidiary of Anthem, Inc. and Novo Nordisk Inc., which manufacturers the once weekly GLP-1 receptor agonist Ozempic (semaglutide), are working together to launch the first of its kind pragmatic study to understand the benefits of semaglutide as compared with all other available diabetes drugs in a real-world pragmatic clinical trial for Type 2 diabetes - one of the nation's fastest growing chronic diseases.

17 Oct 2018

Pediatric antibiotic prescriptions lead to nearly 70,000 ER visits in the U.S. each year

The use of antibiotics drives the development of antibiotic resistance, a major threat to public health worldwide. But these drugs also carry the risk of harm to individual patients, including children.

23 Aug 2018

New drug offers hope to prevent attacks of hereditary angioedema

Hereditary angioedema is a chronic disorder that can sometimes be life-threatening. Now, a new drug therapy has been successfully tested in an international study headed by the University Hospital Frankfurt.

26 Jul 2018

Celgene to share new and updated data around novel hematological therapies

Celgene Corporation today announced that data from a broad range of early and late stage studies evaluating Celgene investigational agents and investigational uses of marketed products will be presented at the 23rd European Hematology Association annual meeting in Stockholm, Sweden, from June 14-17, 2018.

22 May 2018

FDA grants approval to first biosimilar for treatment of patients with breast, stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

4 Dec 2017

AstraZeneca’s new precision biologic gets FDA approval to treat severe eosinophilic asthma

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

14 Nov 2017

ACADIA Pharmaceuticals announces results from Phase II study of antipsychotic in Alzheimer's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced the presentation of data from the Phase II -019 Study of pimavanserin in Alzheimer's disease psychosis at the 10th Clinical Trials on Alzheimer's Disease meeting in Boston.

3 Nov 2017

Shire and Parion Sciences to collaborate on P-321 for ophthalmic indications

Shire plc and Parion Sciences, Inc. have announced they have entered into an agreement granting Shire exclusive worldwide rights to develop and commercialize P-321. Shire will lead development of P-321, an investigational epithelial sodium channel (ENaC) inhibitor for the potential treatment of dry eye disease in adults, with the opportunity for Parion to co-fund.

3 May 2017

Joslin scientists suggest new approach to improve stroke therapy

The standard of care for treating strokes caused by blood clots involves the therapeutic infusion of tissue plasminogen activator (tPA), which can help to dissolve the clots and restore blood flow.

27 Jan 2017

Shire’s Xiidra receives FDA approval for treating dry eye disease in adult patients

Shire plc announces that the U.S. Food and Drug Administration has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients.

12 Jul 2016

TARGET My Hives app for people impacted by chronic urticaria now available in Android, iOS systems

Exco InTouch, a leading provider of digital health technology, announces the launch of the TARGET My Hives app for Android– the digital healthcare platform is now available in both Android and iOS systems.

20 Jun 2016

New RNA aptamer can prevent pathogenic protein misfolding

Several diseases occur when mutations cause misfolding of proteins. These include "serpinopathies" which is a group of rare heritable diseases. They are caused by mutations of so-called "serpin" inhibitors of proteolytic enzymes involved in blood coagulation, tissue remodeling, and other important physiological functions.

10 Jun 2016

Zinbryta gets FDA approval for treating adults with relapsing forms of MS

The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.

28 May 2016

Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Novartis today announced that the United States Food and Drug Administration approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

26 Feb 2016

Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that it has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration seeking approval for the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] to treat children under the age of 12 with hemophilia A and for use in surgical settings.

26 Feb 2016

FDA-approved, once-daily 24-hour aspirin now available for prevention of stroke and acute cardiac events

New Haven Pharmaceuticals, Inc. today announced the availability by prescription of DURLAZA, the first and only 24-hour, extended-release aspirin capsules (162.5mg) approved by the U.S. Food and Drug Administration (FDA) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients.

7 Jan 2016

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

22 Dec 2015

Basaglar (insulin glargine injection) approved to improve glycemic control in diabetes patients

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

17 Dec 2015

New Haven Pharmaceuticals' DURLAZA drug delivers sustained antiplatelet control for full 24 hours

New Haven Pharmaceuticals, Inc. today announced new study data that shows the company's FDA-approved drug DURLAZA delivers sustained antiplatelet control for a full 24-hour period in high-risk patients.

10 Nov 2015