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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.

19 Oct 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.

8 Oct 2015

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.

28 Sep 2015

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.

From Novo Nordisk 26 Sep 2015

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).

16 Sep 2015

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.

9 Sep 2015

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.

26 Aug 2015

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).

20 Aug 2015

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.

12 Aug 2015

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.

4 Aug 2015

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.

25 Jul 2015

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.

24 Jul 2015

Acupuncture can be more effective in treatment of dermatologic conditions

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, "placebo acupuncture," or no treatment, according to a review of the medical literature published in the Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.

15 Jul 2015

Risk of hepatobiliary cancer, cardiovascular diseases later in life is higher in women with ICP

In a new study of more than 125,000 pregnant women in Sweden, researchers 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.

9 Jul 2015

$Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC$

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone.

19 Jun 2015

Tioga Pharmaceuticals announces commencement of asimadoline Phase 2 study for treatment of pruritus

Tioga Pharmaceuticals, a clinical stage biotechnology company, today announced the initiation of a Phase 2 clinical study of asimadoline, a novel, well-studied kappa-opioid receptor specific agonist, for the treatment of pruritus or itching. The double-blind, placebo-controlled clinical study is designed to evaluate the safety, tolerability, and clinical efficacy of asimadoline in patients with pruritus due to atopic dermatitis and is being conducted at 20 clinical study centers in the United States.

11 Jun 2015

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis.

10 Jun 2015

FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent (alirocumab) Injection.

9 Jun 2015

Merck Canada announces conditional approval of KEYTRUDA (pembrolizumab) for melanoma treatment

Merck Canada Inc. announced today that KEYTRUDATM (pembrolizumab) was authorized for sale with conditions by Health Canada on May 19, 2015. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to fight advanced melanoma, the most serious form of skin cancer. It is the first of a new class of therapies called anti-PD-1s approved in Canada.

8 Jun 2015

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted for filing and review its Biologics License Application for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness.

2 Jun 2015