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FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for DALVANCE (dalbavancin) for injection. [More]
Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

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)]. [More]
Novel strategies on the way for difficult-to-treat head and neck cancer

Novel strategies on the way for difficult-to-treat head and neck cancer

Novel strategies are on the way for difficult-to-treat and advanced head and neck cancer, the most heterogeneous group of malignancies which are generally associated with poor survival, and encouraging results have been presented at the first ESMO Asia 2015 Congress in Singapore. [More]
Lilly, Merck announce another immuno-oncology collaboration

Lilly, Merck announce another immuno-oncology collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types. [More]
FDA approves recombinant von Willebrand factor for treating bleeding episodes in adults with VWD

FDA approves recombinant von Willebrand factor for treating bleeding episodes in adults with VWD

The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. [More]
Heightened levels of psychological stress associated with skin complaints in college students

Heightened levels of psychological stress associated with skin complaints in college students

College is a stressful time in the lives of students, and a new study by researchers at the Lewis Katz School of Medicine at Temple University and Temple University found that heightened levels of psychological stress are associated with skin complaints. [More]
Lilly, Merck expand oncology clinical trial collaboration

Lilly, Merck expand oncology clinical trial collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's ALIMTA (pemetrexed for injection) and Merck's KEYTRUDA (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC). [More]
Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda Pharmaceuticals, U.S.A., Inc., today announced that data highlighting the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), will be presented during the 2015 American College of Gastroenterology Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21. [More]
LEO Pharma's Enstilar gets FDA approval for topical treatment of plaque psoriasis

LEO Pharma's Enstilar gets FDA approval for topical treatment of plaque psoriasis

LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, announced today that Enstilar has been approved by the U.S. Food and Drug Administration for the topical treatment of plaque psoriasis in adults 18 years of age and older. [More]
Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan plc today announced that its infectious disease portfolio will be featured in 13 abstracts highlighting data at IDWeek 2015, which takes place from October 7-11, 2015, in San Diego. [More]
Promising drug candidate for chronic intractable itch

Promising drug candidate for chronic intractable itch

If you have an itch, you have to scratch it. But that’s a problem for people with a condition called “chronic intractable itch,” where that itchy sensation never goes away—a difficult-to-treat condition closely associated with dialysis and renal failure. [More]
Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration approved the new drug application for Tresiba (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba provides a long duration of action beyond 42 hours. [More]
AstraZeneca presents safety and efficacy data for ExQW at 51st Annual Meeting of EASD

AstraZeneca presents safety and efficacy data for ExQW at 51st Annual Meeting of EASD

AstraZeneca today announced new analyses of exenatide once weekly (ExQW) demonstrating a favorable gastrointestinal (GI) tolerability profile, including less frequent upper and lower GI adverse events (AE), compared to shorter-acting glucagon-like peptide-1 receptor agonists (GLP-1RA), exenatide twice daily (ExBID) and liraglutide once daily (LiraQD). [More]
Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO (oxycodone HCI, USP) tablets -CII in the United States. [More]
FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira today announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). [More]
Risk of hepatobiliary cancer higher in women with intrahepatic cholestasis of pregnancy

Risk of hepatobiliary cancer higher in women with intrahepatic cholestasis of pregnancy

In a new study of more than 125,000 pregnant women in Sweden, researchers at the Sahlgrenska Academy found that the risk of hepatobiliary cancer and immune-mediated and cardiovascular diseases later in life is higher in women with intrahepatic cholestasis of pregnancy (ICP) than in women without this condition. [More]
Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher Pharmaceuticals Inc. today announced that it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin to the U.S. Food & Drug Administration. [More]
Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis today announced the US Food and Drug Administration has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. [More]
EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. [More]
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