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Incyte seeks FDA marketing approval of ruxolitinib for myelofibrosis

Incyte Corporation announced today that it has submitted a New Drug Application (NDA) for its lead investigational compound, ruxolitinib (INCB18424), to the US Food and Drug Administration (FDA).

6 Jun 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 Jun 2011

Incyte's ruxolitinib Phase III trial data on myelofibrosis presented at ASCO 2011

Incyte Corporation announced today results from the global, pivotal Phase III clinical program of ruxolitinib in patients with myelofibrosis (MF) at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting.

6 Jun 2011

Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced results from a second Phase 3 randomized, double blind study demonstrating that YERVOY (ipilimumab) prolonged the lives of patients with metastatic melanoma.

6 Jun 2011

YM reports updated interim results from CYT387 Phase I/II study on myelofibrosis

YM BioSciences Inc., today reported updated interim safety and efficacy results from the Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the treatment of myelofibrosis.

4 Jun 2011

Roche, Bristol-Myers Squibb to evaluate YERVOY and vemurafenib treatment for metastatic melanoma

Bristol-Myers Squibb Company announced today it has entered in to a clinical collaboration agreement with Roche to evaluate the utility of Bristol-Myers Squibb's CTLA-4 inhibitor, YERVOY (ipilimumab), in combination with Roche's investigational oral BRAF inhibitor, vemurafenib, in treating patients with a specific type of metastatic melanoma.

4 Jun 2011

Vertex Incivek receives FDA approval for treatment of chronic hepatitis C

The U.S. Food and Drug Administration today approved Incivek treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

24 May 2011

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.

20 May 2011

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

YM BioSciences Inc., today reported updated interim results for the first 60 patients with high/intermediate-risk myelofibrosis who have completed a minimum of three cycles of treatment (12 weeks) in its ongoing Phase I/II multi-center study.

19 May 2011

Merck's Phase III study shows efficacy results of tafluprost to treat ocular hypertension

Merck, known as MSD outside the United States and Canada, announced today that new Phase III data showed that patients with open-angle glaucoma or ocular hypertension, who were dosed once-daily with tafluprost, Merck's investigational, preservative-free prostaglandin analogue ophthalmic solution, experienced a reduction in intraocular pressure comparable to patients taking twice-daily preservative-free timolol maleate, a beta-adrenergic antagonist.

3 May 2011

AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

AstraZeneca announced today that the U.S. Food and Drug Administration has approved the use of NEXIUM I.V. for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease with erosive esophagitis when oral therapy is not possible or appropriate.

3 May 2011

Antiviral Drugs Advisory Committee recommends FDA to approve telaprevir for hepatitis C

Vertex Pharmaceuticals Incorporated announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C.

29 Apr 2011

The Lancet publishes phase 3 clinical study data on VIVITROL for treatment of opioid dependence

Alkermes, Inc. today announced that results from the phase 3 clinical study of VIVITROL® (naltrexone for extended-release injectable suspension) in opioid dependence have been published by The Lancet. The six-month, phase 3 trial met its primary endpoint and showed significantly greater opioid-free weeks among patients treated with VIVITROL, compared to placebo.

28 Apr 2011

Rwanda, QIAGEN and Merck launch comprehensive national cervical cancer prevention program

The Government of Rwanda, together with QIAGEN N.V. and Merck, known as MSD outside the United States and Canada, today announced the launch, in Kigali, Rwanda, of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.

From QIAGEN Manchester Limited 25 Apr 2011

Salix Pharmaceuticals receives three U.S. patents relating to rifaximin

Salix Pharmaceuticals, Ltd. today announced that the U.S. Patent and Trademark Office has issued three patents relating to rifaximin.

21 Apr 2011

Baxter's ARTISS phase III study results in face lift surgery presented at AAPS meeting

Baxter International Inc. announced today the results of a phase III study evaluating the safety and efficacy of ARTISS in 75 patients.

From Baxter International Inc. 12 Apr 2011

Positive data from PROCHIEVE vaginal progesterone Phase III study published in peer-reviewed journal

Columbia Laboratories, Inc., and Watson Pharmaceuticals, Inc., today announced the publication of Phase III PROCHIEVE® (progesterone gel) data in today's online version of Ultrasound in Obstetrics & Gynecology, the leading peer-reviewed journal of the International Society of Ultrasound in Obstetrics & Gynecology.

7 Apr 2011

Lupin grants Salix exclusive worldwide rights to rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use. This agreement expands the collaboration that Salix and Lupin entered into as of September 30, 2009.

6 Apr 2011

Vertex announces final results from Phase 3 REALIZE study against HCV

Vertex Pharmaceuticals Incorporated today announced final results from its pivotal Phase 3 REALIZE study that evaluated people with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon and ribavirin was unsuccessful either because they relapsed, had a partial response or had a null response.

1 Apr 2011

Positive results from Intercept OCA Phase II trial in patients with PBC

Intercept Pharmaceuticals, Inc., today announced positive results from a 59 patient, placebo controlled, double-blind Phase II clinical trial of obeticholic acid given as monotherapy to patients with primary biliary cirrhosis.

1 Apr 2011

Pruritus News and Research

Incyte seeks FDA marketing approval of ruxolitinib for myelofibrosis

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Incyte's ruxolitinib Phase III trial data on myelofibrosis presented at ASCO 2011

Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

YM reports updated interim results from CYT387 Phase I/II study on myelofibrosis

Roche, Bristol-Myers Squibb to evaluate YERVOY and vemurafenib treatment for metastatic melanoma

Vertex Incivek receives FDA approval for treatment of chronic hepatitis C

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

Merck's Phase III study shows efficacy results of tafluprost to treat ocular hypertension

AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

Antiviral Drugs Advisory Committee recommends FDA to approve telaprevir for hepatitis C

The Lancet publishes phase 3 clinical study data on VIVITROL for treatment of opioid dependence

Rwanda, QIAGEN and Merck launch comprehensive national cervical cancer prevention program

Salix Pharmaceuticals receives three U.S. patents relating to rifaximin

Baxter's ARTISS phase III study results in face lift surgery presented at AAPS meeting

Positive data from PROCHIEVE vaginal progesterone Phase III study published in peer-reviewed journal

Lupin grants Salix exclusive worldwide rights to rifaximin

Vertex announces final results from Phase 3 REALIZE study against HCV

Positive results from Intercept OCA Phase II trial in patients with PBC

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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