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Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it has successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed Phase III clinical study for COL-003, the Company's tamper-resistant, extended release oxycodone product utilizing its proprietary DETERx technology.

27 Sep 2011

InterMune reports new data from Esbriet clinical trial on IPF

InterMune, Inc. today reported that new data was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet(pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease.

26 Sep 2011

Afinitor Phase III study on angiomyolipomas associated with TSC meets primary endpoint

A Phase III study of Afinitor (everolimus) tablets in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex (TSC) met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors.

26 Sep 2011

Combination of Afinitor, exemestane reduces risk of breast cancer progression in women

A pivotal Phase III study shows Afinitor (everolimus) tablets plus exemestane, a hormonal therapy, more than doubled the time women lived without tumor growth (progression-free survival; PFS) and significantly reduced the risk of cancer progression by 57% versus exemestane alone in patients with advanced breast cancer.

26 Sep 2011

Combination of abiraterone acetate, prednisone reduces fatigue in men with prostate cancer

Men with prostate cancer that has spread to other parts of the body and that is resistant to hormone therapy suffer less from fatigue if they are treated with a combination of abiraterone acetate and prednisone, according to results from a phase III clinical trial presented today.

26 Sep 2011

Regeneron announces additional data from aflibercept Phase 3 trial on colorectal cancer

Regeneron Pharmaceuticals, Inc. today announced that additional data from the Phase 3 VELOUR trial will be presented at the 2011 European Multidisciplinary Cancer Congress (EMCC) which will take place from September 23-27 in Stockholm, Sweden.

26 Sep 2011

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

First Radium-223 Chloride Phase III study in prostate cancer

Until recently, options for patients with bone metastases from advanced prostate cancer have been very limited. But now the first Phase III study of an alpha-pharmaceutical in these patients has shown that it can prolong survival significantly, according to research reported today (Saturday) at the 2011 European Multidisciplinary Cancer Congress.

26 Sep 2011

RegeneRx completes RGN-259 Phase 2 trial on dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. today announced that treatment and follow-up have been completed on 69 patients in the Company's Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial's protocol.

26 Sep 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Soy protein reduces progression of atherosclerosis in women within 5 years of menopause

A new study published in the November 2011 issue of Stroke reveals some promising data on the positive effects of soy protein reducing the progression of clogged arteries in women who were within five years of menopause. This study was the largest and longest randomized controlled human study conducted to-date that directly investigated the efficacy of isolated soy protein consumption on the progression of atherosclerosis.

23 Sep 2011

Levosimendan may effectively improve muscle function in patients with respiratory failure

Treatment with the calcium-sensitizing drug levosimendan may be effective in improving muscle function in patients with respiratory muscle weakness, which often accompanies chronic diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure, according to researchers in the Netherlands, who studied the effects of the drug on healthy volunteers.

23 Sep 2011

Anti-obesity drug Contrave may get another chance to prove itself

With rise obesity around the world there should have been a number of drugs to combat it. The reality is different. There are no safe and effective drugs in the market at present.

22 Sep 2011

Aradigm announces two ciprofloxacin Phase 2b study data on non-CF bronchiectasis

Aradigm Corporation today announced it is presenting data on September 26, 2011, from its Phase 2b studies at the ERS Annual Congress in Amsterdam, Netherlands. The two podium presentations review the results from the Company's two clinical trials of inhaled ciprofloxacin in non-cystic fibrosis bronchiectasis (BE) patients.

22 Sep 2011

Theraclone initiates TCN-032 Phase 1 trial in influenza A

Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, announced today first dosing of subjects in a Phase 1 clinical trial of TCN-032, a broadly protective, fully human monoclonal antibody for the treatment of influenza A virus.

22 Sep 2011

NEJM publishes Boehringer Ingelheim's BIBF 1120 phase II trial on IPF

Boehringer Ingelheim's investigational tyrosine kinase inhibitor (TKI) BIBF 1120 demonstrated a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF), according to phase II clinical trial results published today online in the New England Journal of Medicine.

22 Sep 2011

S-equol improve appearance of crow's feet skin wrinkles in Japanese menopausal women

A soy germ-based nutritional supplement containing Natural S-equol significantly improved the appearance of crow's feet skin wrinkles of the outer corner of the eyes in Japanese menopausal women, suggesting that supplements containing Natural S-equol have potential to slow skin aging, according to data from a controlled pilot study simultaneously published online in the peer-review journal Menopause and presented in a poster session at the North American Menopause Society annual meeting.

22 Sep 2011

Children of parents with drink problem may consume more alcohol after stressful situations

If either of your parents has a drink problem, there is a greater risk that you will consume more alcohol after stressful situations, reveals current research from the Sahlgrenska Academy, at the University of Gothenburg, Sweden.

21 Sep 2011

New research has potential to alleviate side effects of cancer treatments

Beth Faiman MSN, CNP, a doctoral candidate at the Frances Payne Bolton School of Nursing at Case Western Reserve University, is studying whether an over-the-counter medication could ease chemotherapy side effects for people with blood and bone marrow cancers.

20 Sep 2011

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

Santarus, Inc., a specialty biopharmaceutical company, today announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis.

20 Sep 2011

Placebo News and Research

Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

InterMune reports new data from Esbriet clinical trial on IPF

Afinitor Phase III study on angiomyolipomas associated with TSC meets primary endpoint

Combination of Afinitor, exemestane reduces risk of breast cancer progression in women

Combination of abiraterone acetate, prednisone reduces fatigue in men with prostate cancer

Regeneron announces additional data from aflibercept Phase 3 trial on colorectal cancer

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

First Radium-223 Chloride Phase III study in prostate cancer

RegeneRx completes RGN-259 Phase 2 trial on dry eye syndrome

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Soy protein reduces progression of atherosclerosis in women within 5 years of menopause

Levosimendan may effectively improve muscle function in patients with respiratory failure

Anti-obesity drug Contrave may get another chance to prove itself

Aradigm announces two ciprofloxacin Phase 2b study data on non-CF bronchiectasis

Theraclone initiates TCN-032 Phase 1 trial in influenza A

NEJM publishes Boehringer Ingelheim's BIBF 1120 phase II trial on IPF

S-equol improve appearance of crow's feet skin wrinkles in Japanese menopausal women

Children of parents with drink problem may consume more alcohol after stressful situations

New research has potential to alleviate side effects of cancer treatments

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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