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Taiho Pharmaceutical obtains approval in Japan for anticancer drug Lonsurf

Taiho Pharmaceutical Co., Ltd. (Tokyo, President: Masayuki Kobayashi) announced on March 24 that it has obtained approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market the oral combination anticancer drug "Lonsurf(R) combination tablet T15, T20" (nonproprietary names: trifluridine and tipiracil hydrochloride; development code: TAS-102), for the treatment of patients with unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies).

24 Mar 2014

FDA approves Xolair for treatment of chronic idiopathic urticaria

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, a form of chronic hives.

24 Mar 2014

Otsuka obtains regulatory approval in Japan for pharmacological treatment of ADPKD

Otsuka Pharmaceutical Co., Ltd. today announced it has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD). Samsca (generic name: tolvaptan) has been approved in Japan in 7.5-mg and 15-mg tablet forms for extended use for the additional indication of ADPKD. Also, the new dosage form of 30-mg Samsca tablets has received approval for the indication of ADPKD.

24 Mar 2014

New weapon against secondary progressive MS

Statins may provide doctors with an unlikely new weapon with which to slow the progression of multiple sclerosis (MS).

20 Mar 2014

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

Emmaus Life Sciences, Inc., a biopharmaceutical company dedicated primarily to the discovery, development and commercialization of innovative treatments and therapies for rare and orphan diseases, today announced that preliminary top-line results of its Phase 3 clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial.

20 Mar 2014

New data shows curative effects of GFT505 in NASH associated with metabolic disorders

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces new data from Professor Isabelle Leclercq of Université Catholique de Louvain (Belgium) demonstrating the curative effects of GFT505 in an experimental model of NASH associated with metabolic disorders.

20 Mar 2014

Tamiflu cuts H1N1 pandemic deaths by 25%, shows study

Adults hospitalised with H1N1 influenza during the 2009–2010 pandemic were 25% less likely to die from the disease if they were given antiviral drugs called neuraminidase inhibitors (NAIs) such as Tamiflu, according to a large meta-analysis involving more than 29 000 patients from 38 countries, published in The Lancet Respiratory Medicine journal. The findings also indicate that treatment within 2 days of flu symptoms developing halved the risk of death compared with later treatment or no treatment.

20 Mar 2014

Simvastatin may slow progression of multiple sclerosis

Results of a phase 2 study published in The Lancet suggest that simvastatin, a cheap cholesterol lowering drug, might be a potential treatment option for the secondary progressive, or chronic, stage of multiple sclerosis (MS), which is currently untreatable.

20 Mar 2014

Ipsen: Dysport Phase IIa clinical trial effective in treatment of NDO

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced positive results from its phase IIa clinical trial assessing Dysport in the treatment of Neurogenic Detrusor Overactivity (NDO) in patients with urinary incontinence not adequately managed by anticholinergics.

19 Mar 2014

Playing science-based mobile gaming app for 25 minutes can reduce anxiety

Playing a science-based mobile gaming app for 25 minutes can reduce anxiety in stressed individuals, according to research published in Clinical Psychological Science, a journal of the Association for Psychological Science.

19 Mar 2014

Amgen announces results from Phase 3 TESLA Trial of evolocumab in patients with HoFH

Amgen (NASDAQ: AMGN) today announced that the Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C).

19 Mar 2014

Medivir announces phase III ATTAIN study of simeprevir inhibitor in treatment of adult patients with HCV

Medivir AB today announced that new phase III data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia.

19 Mar 2014

Ironwood Pharmaceuticals starts Phase IIa clinical study of IW-3718 for gastroesophageal reflux disease

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that dosing has begun in its Phase IIa clinical study of its investigational compound IW-3718 in patients suffering from gastroesophageal reflux disease (GERD) who have not responded adequately to treatment with a proton pump inhibitor (PPI). Data are expected in the first half of 2015.

18 Mar 2014

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy".

18 Mar 2014

Ocular Therapeutix starts Phase 3 clinical program to evaluate safety, efficacy of dexamethasone

Ocular Therapeutix, Inc. announces the start of its Phase 3 clinical program to evaluate the safety and efficacy of their sustained release dexamethasone, an ophthalmic corticosteroid for the treatment of post-operative inflammation and pain following cataract surgery. Ocular Therapeutix's dexamethasone is administered as a one-time, bioabsorbable intracanalicular plug for release of the steroid to the ocular surface for up 30 days.

18 Mar 2014

L. reuteri Protectis reduces diarrhea, respiratory tract infections in healthy children

Healthy children attending day-care centres have a significantly lower risk of getting diarrhoea or respiratory tract infections when given a daily supplement of Lactobacillus reuteri Protectis, a study in 336 children shows. "Our study confirms earlier published data in proving that preventive use of L. reuteri Protectis in healthy children reduces diarrhoeic episodes.

17 Mar 2014

Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

Edison Pharmaceuticals today announced the initiation of a phase 2 study entitled "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone™) in Children with Pearson Syndrome." The Investigative New Drug application (IND) was approved by the Food and Drug Administration, Office of Hematology and Oncology Products.

17 Mar 2014

FDA grants Fast Track designation to Edison’s lead drug EPI-743

Edison Pharmaceuticals today announced that the United States Food and Drug Administration granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. EPI-743 is being developed for pediatric and adult mitochondrial disease, including Friedreich's ataxia.

17 Mar 2014

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

16 Mar 2014

Stem cell therapy may benefit patients with debilitating heart failure

Researchers want to know whether patients with debilitating heart failure can benefit by having their own stem cells injected into their ailing heart muscle.

14 Mar 2014

Placebo News and Research

Taiho Pharmaceutical obtains approval in Japan for anticancer drug Lonsurf

FDA approves Xolair for treatment of chronic idiopathic urticaria

Otsuka obtains regulatory approval in Japan for pharmacological treatment of ADPKD

New weapon against secondary progressive MS

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

New data shows curative effects of GFT505 in NASH associated with metabolic disorders

Tamiflu cuts H1N1 pandemic deaths by 25%, shows study

Simvastatin may slow progression of multiple sclerosis

Ipsen: Dysport Phase IIa clinical trial effective in treatment of NDO

Playing science-based mobile gaming app for 25 minutes can reduce anxiety

Amgen announces results from Phase 3 TESLA Trial of evolocumab in patients with HoFH

Medivir announces phase III ATTAIN study of simeprevir inhibitor in treatment of adult patients with HCV

Ironwood Pharmaceuticals starts Phase IIa clinical study of IW-3718 for gastroesophageal reflux disease

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Ocular Therapeutix starts Phase 3 clinical program to evaluate safety, efficacy of dexamethasone

L. reuteri Protectis reduces diarrhea, respiratory tract infections in healthy children

Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

FDA grants Fast Track designation to Edison’s lead drug EPI-743

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Stem cell therapy may benefit patients with debilitating heart failure

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