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Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Pfizer Inc. today announced that the ORAL Sync Phase 3 study of tofacitinib, formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis, met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4 <2.6 at six months.

5 Mar 2011

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

Giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months halved the risk of HIV transmission to the infants at age 6 months compared with giving infants the drug daily for six weeks, according to preliminary clinical trial data presented today.

4 Mar 2011

European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved a label update for ONGLYZA in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the patient group is a new once-daily 2.5 mg dose.

4 Mar 2011

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Eisai Inc. today announced that the U.S. Food and Drug Administration has approved BANZEL Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

3 Mar 2011

Rockwell Medical fourth quarter net loss increases to $1.7 million

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today fourth quarter and full-year 2010 results.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Depomed, Inc. announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada for the non-hormonal treatment of menopausal hot flashes.

3 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Osiris Therapeutics, Inc., today announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal, an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack.

3 Mar 2011

Scientists devise new on-line calculator to predict food allergies in children

An on-line calculator that predicts, within seconds, the presence of the three major food allergies in children has been developed by researchers at University College Cork.

2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

From Baxter International Inc. 2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Vaccine-induced cellular immune responses against HIV-1 infection exert selective pressure on the virus

An AIDS vaccine tested in people, but found to be ineffective, influenced the genetic makeup of the virus that slipped past. The findings suggest new ideas for developing HIV vaccines.

2 Mar 2011

High blood pressure medications useful even in those without hypertension: Study

Researchers have studied existing evidence to suggest that people who have had a stroke or a heart attack might benefit from taking blood pressure medications, even if they do not have high blood. They noted that for every 1,000 people taking the drugs in clinical trials, on average 15 fewer died from heart disease than when the patients got dummy treatment. The study however could not explain the cause for this benefit. The study, which was funded by Tulane University and the National Institutes of Health, was published in the March 2 issue of the Journal of the American Medical Association.

1 Mar 2011

QLT fourth quarter revenues decrease 7.3% to $10.0 million

QLT Inc. today reported financial results for the fourth quarter ended December 31, 2010 and full year 2010 as well as issued its guidance for 2011. Unless specified otherwise, all amounts are in U.S. dollars and in accordance with U.S. GAAP.

1 Mar 2011

FDA approves Forest Labs' Daliresp to treat COPD

Forest Laboratories, Inc. announced today that Daliresp was approved by the U.S. Food and Drug Administration as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

1 Mar 2011

Tenofovir gel more effective than oral tablet for HIV treatment: Study

In the first study to make head-to-head comparisons between tenofovir gel and oral tenofovir - two promising approaches for preventing HIV in women - researchers found that daily use of the vaginal gel achieved a more than 100-times higher concentration of active drug in vaginal tissue than did the oral tablet, while, compared to the gel, the tablet used daily was associated with a 20-times higher active drug concentration in blood.

1 Mar 2011

Anti-AIDS gel shows promise

Dr. Ian McGowan, a professor of medicine at the University of Pittsburgh who is leading a second-phase study of the gel said, “These are early results, but [they] help set the stage for current and future trials of rectal microbicides and the development of a rectal-specific formulation of tenofovir gel.” Researchers have focused on the use of microbicides such as tenofovir, as a preventive treatment to be used in vaginal sex. However, scientists think unprotected anal sex is much more risky.

1 Mar 2011

Intercell reports EUR 255.2m net loss for full year 2010

Today Intercell AG announced its financial results for Q4 and the preliminary results for the full financial year 2010 and presented an update on the Company's development programs.

1 Mar 2011

Placebo News and Research

Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Rockwell Medical fourth quarter net loss increases to $1.7 million

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Scientists devise new on-line calculator to predict food allergies in children

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Vaccine-induced cellular immune responses against HIV-1 infection exert selective pressure on the virus

High blood pressure medications useful even in those without hypertension: Study

QLT fourth quarter revenues decrease 7.3% to $10.0 million

FDA approves Forest Labs' Daliresp to treat COPD

Tenofovir gel more effective than oral tablet for HIV treatment: Study

Anti-AIDS gel shows promise

Intercell reports EUR 255.2m net loss for full year 2010

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