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Genentech receives FDA approval for Actemra to treat juvenile idiopathic arthritis

The U.S. Food and Drug Administration today approved Actemra, given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis in children ages 2 years and older.

15 Apr 2011

New dengue test receives FDA marketing clearance

The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

11 Apr 2011

Hartwell honors UCSD scientists with Individual Biomedical Research Award

Three scientists at the University of California, San Diego School of Medicine are among this year's 12 winners of Hartwell Individual Biomedical Research Awards, honoring researchers whose work advances children's health.

7 Apr 2011

AstraZeneca receives FDA approval for vandetanib to treat medullary thyroid cancer

The U.S. Food and Drug Administration today approved vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.

7 Apr 2011

Boehringer Ingelheim receives FDA approval for Viramune XR to treat HIV-1 infection

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Viramune XR extended-release tablets, a one-pill, once-daily formulation of nevirapine for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

5 Apr 2011

Positive results from GDC-0973, GDC-0941 combination therapy Phase I trial against cancer

The combination of two compounds that inhibit two of the most frequently mutated cancer pathways is showing promise in an ongoing Phase I trial, according to data presented at the AACR 102nd Annual Meeting 2011, held here April 2-6.

4 Apr 2011

Study: Nanoparticles can prevent nickel-induced dermatitis

Tiny particles only billionths of a meter in diameter-about two thousand would fit across the width of a human hair-could offer big hope in a small package to the many millions of people who are allergic to the nickel in everything from jewelry to coins and cell phones, say scientists at Brigham and Women's Hospital.

4 Apr 2011

Boehringer Ingelheim's BI 201335 new data against HCV highlighted at EASL meeting

New data presented today at the International Liver CongressTM 2011, the 46th Annual Meeting of the European Association for the Study of the Liver, in Berlin, highlighted the efficacy of Boehringer Ingelheim's once-daily oral protease inhibitor BI 201335, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus infection. Genotype-1 HCV is the most challenging genotype of HCV to treat.

2 Apr 2011

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

New data presented today at the 46th Annual Meeting of the European Association for the Study of the Liver demonstrate the antiviral activity of Boehringer Ingelheim's once-daily oral protease inhibitor, BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus, the most challenging genotype of HCV to treat.

1 Apr 2011

Amgen appeals EMA CHMP negative opinion on Vectibix-chemotherapy combination for wild-type KRAS mCRC

Amgen announced today that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in March by the Committee For Medicinal Products for Human Use (CHMP) for the use of Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC).

31 Mar 2011

Mary Ann Liebert to launch new 'Shingles and PHN' open access journal

Shingles and PHN, a new, bimonthly open access peer-reviewed journal, will be launched in fall 2011 by Mary Ann Liebert, Inc., publishers.

30 Mar 2011

U.S. FDA approves Yervoy to treat patients with late-stage melanoma

The U.S. Food and Drug Administration today approved Yervoy to treat patients with late-stage melanoma, the most dangerous type of skin cancer.

28 Mar 2011

Purdue demonstrates efficacy of Butrans transdermal delivery system for chronic pain in opioid-naive patients

Physicians from Purdue Pharma LP, Stamford, CT, showcased study results that demonstrate the analgesic efficacy and safety of Butrans for the relief of moderate to severe chronic low back pain in opioid-naive patients. Butrans is a transdermal delivery system that provides systemic delivery of buprenorphine, a Schedule III medication, continuously over a 7-day period.

25 Mar 2011

Positive top-line results from Targacept's TC-5619 Phase 2 trial in adults with ADHD

Targacept, Inc today announced top-line results from a Phase 2 proof of concept trial of TC-5619 as a treatment for adults with attention deficit/hyperactivity disorder.

25 Mar 2011

Researchers identify gene that can predict hypersensitivity to epilepsy drug

Research published this week in the New England Journal of Medicine. A multinational team of scientists led by the Royal College of Surgeons in Ireland and the University of Liverpool has identified a gene that could indicate if epilepsy patients starting a common drug treatment are likely to experience side-effects ranging from a mild skin irritation to the potentially fatal Steven-Johnson Syndrome.

25 Mar 2011

Merck & Co receives FDA approval for Zostavax vaccine to treat shingles

The Food and Drug Administration today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

25 Mar 2011

MnSOD oral drug can protect against lung cancer radiation therapy

Patients with advanced non-small cell lung cancer can safely take an experimental oral drug intended to protect healthy tissue from the effects of radiation, according to a study led by researchers at the University of Pittsburgh Cancer Institute and published in this month's issue of Human Gene Therapy.

23 Mar 2011

EMA CHMP adopts negative opinion for Amgen's Vectibix in treatment of wild-type KRAS metastatic colorectal cancer

Amgen has received notice that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Amgen's application to extend the marketing authorization in Europe for Vectibix® (panitumumab) to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).

18 Mar 2011

FDA advisory panel votes in favor of NovoTTF-100A System for supra-tentorial glioblastoma multiforme tumors

Novocure announced today that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted (7 yes; 3 no; 2 abstain) that for patients with supra-tentorial glioblastoma multiforme (GBM) tumors that recur after maximal surgical and radiation treatments, there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) outweigh its risks when administered as a monotherapy in place of standard medical therapy.

18 Mar 2011

New drug for Lupus approved

A new drug for lupus has won U.S. approval. The drug, Benlysta from Human Genome Sciences Inc., is administered once a month intravenously.

12 Mar 2011

Rash News and Research

Genentech receives FDA approval for Actemra to treat juvenile idiopathic arthritis

New dengue test receives FDA marketing clearance

Hartwell honors UCSD scientists with Individual Biomedical Research Award

AstraZeneca receives FDA approval for vandetanib to treat medullary thyroid cancer

Boehringer Ingelheim receives FDA approval for Viramune XR to treat HIV-1 infection

Positive results from GDC-0973, GDC-0941 combination therapy Phase I trial against cancer

Study: Nanoparticles can prevent nickel-induced dermatitis

Boehringer Ingelheim's BI 201335 new data against HCV highlighted at EASL meeting

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

Amgen appeals EMA CHMP negative opinion on Vectibix-chemotherapy combination for wild-type KRAS mCRC

Mary Ann Liebert to launch new 'Shingles and PHN' open access journal

U.S. FDA approves Yervoy to treat patients with late-stage melanoma

Purdue demonstrates efficacy of Butrans transdermal delivery system for chronic pain in opioid-naive patients

Positive top-line results from Targacept's TC-5619 Phase 2 trial in adults with ADHD

Researchers identify gene that can predict hypersensitivity to epilepsy drug

Merck & Co receives FDA approval for Zostavax vaccine to treat shingles

MnSOD oral drug can protect against lung cancer radiation therapy

EMA CHMP adopts negative opinion for Amgen's Vectibix in treatment of wild-type KRAS metastatic colorectal cancer

FDA advisory panel votes in favor of NovoTTF-100A System for supra-tentorial glioblastoma multiforme tumors

New drug for Lupus approved

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